Purpose

This randomized phase III trial studies how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients with stage III-IV melanoma that contains a mutation known as BRAFV600 and cannot be removed by surgery. Ipilimumab and nivolumab may block tumor growth by targeting certain cells. Dabrafenib and trametinib may block tumor growth by targeting the BRAFV600 gene. It is not yet known whether treating patients with ipilimumab and nivolumab followed by dabrafenib and trametinib is more effective than treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Criteria


Inclusion Criteria:

- STEP 1

- Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1

- Women must not be pregnant or breast-feeding

- All females of childbearing potential must have a blood test or urine study
within 2 weeks prior to registration to rule out pregnancy

- A female of childbearing potential is any woman, regardless of sexual orientation
or whether they have undergone tubal ligation, who meets the following criteria:
1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been
naturally postmenopausal for at least 24 consecutive months (i.e., has had menses
at any time in the preceding 24 consecutive months)

- Women of child-bearing potential and sexually active males must agree to use at least
two other accepted and effective methods of contraception and/or to abstain from
sexual intercourse for the duration of their participation in the study, and for at
least 4 weeks after treatment with dabrafenib or for 4 months after dabrafenib in
combination with trametinib; women of child-bearing potential must use at least two
other accepted and effective methods of contraception and/or to abstain from sexual
intercourse for at least 5 months after the last dose of nivolumab and/or ipilimumab
and sexually active males must use at least two other accepted and effective methods
of contraception and/or abstain from sexual intercourse for at least 7 months after
the last dose of nivolumab and/or ipilimumab; should a woman become pregnant or
suspect she is pregnant while she is participating in this study, she should inform
her treating physician immediately

- Patients must have unresectable stage III or stage IV disease

- Patients must have measurable disease; all sites of disease must be evaluated within 4
weeks prior to randomization

- Patients must have histological or cytological confirmation of melanoma that is
metastatic or unresectable and clearly progressive

- NOTE: Any patient with BRAF V600 mutant melanoma (whether cutaneous, acral or
mucosal primary) who meets the eligibility criteria is eligible for participation
in this trial; patients with uveal melanoma are not eligible for this trial

- Patients must have BRAF V600 mutation, identified by a Food and Drug Administration
(FDA)-approved test at a Clinical Laboratory Improvement Act (CLIA)-certified lab; if
test at CLIA-certified lab used a non-FDA approved method, information about the assay
must be provided (FDA approved tests for BRAF V600 mutations in melanoma include:
THxID BRAF Detection Kit and Cobas 4800 BRAF V600 Mutation Test)

- Patients may have had prior systemic therapy in the adjuvant setting; however this
adjuvant treatment must not have included a CTLA4 or PD1 pathway blocking antibody or
a BRAF/MEK inhibitor; also, patients may not have had any prior systemic treatment for
advanced (measurable metastatic) disease

- Patients must have discontinued chemotherapy, immunotherapy or other investigational
agents used in the adjuvant setting >= 4 weeks prior to entering the study and
recovered from adverse events due to those agents; mitomycin and nitrosoureas must
have been discontinued at least 6 weeks prior to entering the study; patients must
have discontinued radiation therapy >= 2 weeks prior to entering the study and
recovered from any adverse events associated with treatment; prior surgery must be >=
4 weeks from registration and patients must be fully recovered from post-surgical
complications

- Patients must not receive any other investigational agents while on study or within
four weeks prior to registration

- Patients are ineligible if they have any currently active central nervous system (CNS)
metastases; patients who have treated brain metastases (with either surgical resection
or stereotactic radiosurgery [SRS]) could be eligible; patients must not have taken
any steroids =< 10 days prior to randomization for the purpose of managing their brain
metastases; patients with only whole brain irradiation for treatment of CNS metastases
will be ineligible

- Patients must not have other current malignancies, other than basal cell skin cancer,
squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in
situ of the breast; patients with other malignancies are eligible if they have been
continuously disease-free for > 3 years prior to the time of registration; patients
with history of RAS mutation-positive tumors are not eligible regardless of interval
from the current study; Note: prospective RAS testing is not required; however, if the
results of previous RAS testing are known, they must be used in assessing eligibility

- White blood count >= 3,000/uL, obtained within 4 weeks prior to randomization

- Absolute neutrophil count (ANC) >= 1,500/uL, obtained within 4 weeks prior to
randomization

- Platelet count >= 100,000/uL, obtained within 4 weeks prior to randomization

- Hemoglobin > 9 g/dL, obtained within 4 weeks prior to randomization

- Serum creatinine =< 1.5 x upper limit of normal (ULN) or serum creatinine clearance
(CrCl) >= 40 ml/min, obtained within 4 weeks prior to randomization

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN (=< 5 x
ULN for patients with documented liver metastases)

- Alkaline phosphatase =< 2 x ULN (=< 5 x ULN for patients with known liver involvement
and =< 7 x ULN for patients with known bone involvement)

- Total bilirubin =< 1.5 x ULN except subjects with normal direct bilirubin or those
with known Gilbert's syndrome, obtained within 4 weeks prior to randomization

- Serum lactate dehydrogenase (LDH) < 10 X ULN (patients with LDH > 10 X ULN are felt to
have aggressive disease and should be considered for BRAF inhibitor therapy off
protocol), obtained within 4 weeks prior to randomization

- Patients must not have any serious or unstable pre-existing medical conditions (aside
from malignancy exceptions specified above), including but not limited to, ongoing or
active infection requiring parenteral antibiotics on day 1, history of bleeding
diathesis or need for concurrent anticoagulation (international normalized ratio [INR]
=< 1.5 and partial thromboplastin time [PTT] within 1.1 x ULN), or psychiatric
illness/social situations that would limit compliance with study requirements,
interfere with subject's safety, or obtaining informed consent; therapeutic level
dosing of warfarin can be used with close monitoring of prothrombin time (PT)/INR by
the site; exposure may be decreased due to enzyme induction when on treatment, thus
warfarin dosing may need to be adjusted based upon PT/INR; consequently, when
discontinuing dabrafenib, warfarin exposure may be increased and thus close monitoring
via PT/INR and warfarin dose adjustments must be made as clinically appropriate;
prophylactic low dose warfarin may be given to maintain central catheter patency

- Patients must not have a history of or evidence of cardiovascular risks including any
of the following:

- QT interval corrected for heart rate using the Bazett's formula (QTcB) >= 480
msec. at baseline

- History of acute coronary syndromes (including myocardial infarction or unstable
angina), coronary angioplasty, or stenting within the past 24 weeks prior to
registration

- History prior to registration or evidence of current >= class II congestive heart
failure as defined by the New York Heart Association (NYHA) functional
classification system

- Left ventricular ejection fraction (LVEF) =< lower limit of normal on cardiac
echocardiogram (echo) or multi gated acquisition scan (MUGA)

- Intra-cardiac defibrillator

- History of abnormal cardiac valve morphology (>= grade 2) documented by ECHO
(subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be
entered on study); subjects with moderate valvular thickening should not be
entered on study

- History or evidence of current clinically significant uncontrolled cardiac
arrhythmias; clarification: subjects with atrial fibrillation controlled for > 30
days prior to dosing are eligible

- Treatment refractory hypertension defined as a blood pressure of systolic > 140
mmHg and/or diastolic > 90 mm Hg which cannot be controlled by anti-hypertensive
therapy

- Individuals who are known to be human immunodeficiency virus (HIV) infected are
eligible (note: HIV testing is not required for entry into the study)

- Patients with evidence of active hepatitis B virus (HBV) or hepatitis C Virus (HCV)
infection are not eligible; patients with cleared HBV and HCV infection will be
allowed

- Patients with active autoimmune disease or history of autoimmune disease that might
recur, which may affect vital organ function or require immune suppressive treatment
including systemic corticosteroids, should be excluded; these include but are not
limited to patients with a history of immune related neurologic disease, multiple
sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia
gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE),
connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's,
ulcerative colitis, hepatitis; and patients with a history of toxic epidermal
necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be
excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed
with replacement hormones including physiologic corticosteroids are eligible; patients
with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis
controlled with topical medication and patients with positive serology, such as
antinuclear antibodies (ANA), should be evaluated for the presence of target organ
involvement and potential need for systemic treatment; if no systemic immune
suppression is deemed necessary they can be eligible

- The following medications or non-drug therapies are also prohibited while on treatment
in this study:

- Other anti-cancer therapies

- Other investigational drugs

- Patients taking any medications or substances that are strong inhibitors or
inducers of CYP3A or CYP2C8 are ineligible

- Patients must not have history of retinal vein occlusion (RVO)

- Patients must not have evidence of interstitial lung disease or pneumonitis

- Patients must not have malabsorption, swallowing difficulty, or other conditions that
would interfere with the ingestion or absorption of dabrafenib or trametinib

- STEP 2 (CROSSOVER ARM FOR PATIENTS WITH PROGRESSIVE DISEASE)

- The patient must have met all eligibility criteria (except as detailed below) at the
time of crossover

- RECIST defined measurable disease is not required

- Only prior systemic therapy as part of step 1 is allowed; patients who received
allowed systemic therapy in the adjuvant setting prior to Step 1 and were
eligible for Step 1 are not excluded from proceeding to Step 2 if they meet other
eligibility criteria

- Malabsorption, swallowing difficulty, or other conditions that would interfere
with the ingestion or absorption of dabrafenib or trametinib, or history of
retinal vein occlusion are acceptable for patients crossing over to ipilimumab +
nivolumab treatment

- History of autoimmune disease, excluding interstitial lung disease or
pneumonitis, is allowed in patients crossing over to dabrafenib/trametinib
therapy

- Patients crossing over from nivolumab/ipilimumab to dabrafenib/trametinib who
underwent surgery or SRS to CNS metastases need not be off of steroids to start
treatment

- There is no restriction on serum LDH at crossover

- Patients with a history of cardiovascular risks that developed during step 1 of
therapy should be discussed with study principal investigator (PI) at time of
crossover

- Patients must have melanoma that is metastatic and clearly progressive on prior
therapy

- Patients must be at least 2 weeks and within 12 weeks from documented progressive
disease (PD) on Step 1 of current study; all sites of disease must be evaluated within
4 weeks prior to registration

- Patients must have recovered from adverse events (toxicities resolved to grade 1 or
less) of prior therapy; patients with immune related toxicities from ipilimumab +
nivolumab may continue onto Step 2 even if still on steroids to control side effects,
so long as toxicity has resolved to grade 1 or less

- Patients must have discontinued radiation therapy prior to registering to Step 2 of
the study and recovered from any adverse events associated with treatment; prior
surgery must be >= 2 weeks from registration to Step 2 and patients must be fully
recovered from post-surgical complications

- Patients are ineligible if they have any currently active CNS metastases; patients who
have treated brain metastases (with either surgical resection or stereotactic
radiosurgery [SRS]) could be eligible to proceed; patients crossing over from
dabrafenib/trametinib to nivolumab (nivo)/ipilimumab (ipi) must not have taken any
steroids =< 10 days prior to registration for the purpose of managing their brain
metastases; patients with only whole brain irradiation for treatment of CNS metastases
are ineligible

- Patients must not have other current malignancies, other than basal cell skin cancer,
squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in
situ of the breast

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A (immunotherapy)
IMMUNOTHERAPY INDUCTION (COURSES 1-2): Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. IMMUNOTHERAPY MAINTENANCE (COURSES 3-14): Patients receive nivolumab IV over 60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients re-register and cross over to Arm C.
  • Biological: Ipilimumab
    Given IV
    Other names:
    • Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
    • BMS-734016
    • MDX-010
    • MDX-CTLA4
    • Yervoy
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Biological: Nivolumab
    Given IV
    Other names:
    • BMS-936558
    • MDX-1106
    • NIVO
    • ONO-4538
    • Opdivo
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
Experimental
Arm B (BRAF inhibitor therapy)
Patients receive dabrafenib PO BID and trametinib PO daily on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients re-register and cross over to Arm D.
  • Drug: Dabrafenib
    Given PO
    Other names:
    • BRAF Inhibitor GSK2118436
    • GSK-2118436A
    • GSK2118436
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Drug: Trametinib
    Given PO
    Other names:
    • GSK1120212
    • JTP-74057
    • MEK Inhibitor GSK1120212
    • Mekinist
Experimental
Arm C (BRAF inhibitor therapy)
Patients receive dabrafenib PO BID and trametinib PO daily on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
  • Drug: Dabrafenib
    Given PO
    Other names:
    • BRAF Inhibitor GSK2118436
    • GSK-2118436A
    • GSK2118436
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Drug: Trametinib
    Given PO
    Other names:
    • GSK1120212
    • JTP-74057
    • MEK Inhibitor GSK1120212
    • Mekinist
Experimental
Arm D (immunotherapy)
IMMUNOTHERAPY INDUCTION (COURSES 1-2): Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. IMMUNOTHERAPY MAINTENANCE (COURSES 3-14): Patients receive nivolumab IV over 60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
  • Biological: Ipilimumab
    Given IV
    Other names:
    • Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
    • BMS-734016
    • MDX-010
    • MDX-CTLA4
    • Yervoy
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Biological: Nivolumab
    Given IV
    Other names:
    • BMS-936558
    • MDX-1106
    • NIVO
    • ONO-4538
    • Opdivo
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment

Recruiting Locations

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
Contact:
Robert M. Conry
800-828-8816

Anchorage Associates in Radiation Medicine
Anchorage, Alaska 98508
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Alaska Breast Care and Surgery LLC
Anchorage, Alaska 99508
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Alaska Oncology and Hematology LLC
Anchorage, Alaska 99508
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Alaska Women's Cancer Care
Anchorage, Alaska 99508
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Anchorage Oncology Centre
Anchorage, Alaska 99508
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Katmai Oncology Group
Anchorage, Alaska 99508
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Providence Alaska Medical Center
Anchorage, Alaska 99508
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Fairbanks Memorial Hospital
Fairbanks, Alaska 99701
Contact:
John A. Keech
907-458-5380

CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas 71913
Contact:
Mehmet S. Copur
308-398-6518
clinicaltrials@sfmc-gi.org

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Issam Makhoul
501-686-8274

Kaiser Permanente-Anaheim
Anaheim, California 92807
Contact:
Gary L. Buchschacher
626-564-3455

Kaiser Permanente-Baldwin Park
Baldwin Park, California 91706
Contact:
Gary L. Buchschacher
626-564-3455

Kaiser Permanente-Bellflower
Bellflower, California 90706
Contact:
Gary L. Buchschacher
626-564-3455

Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California 94704
Contact:
Jorge A. Garcia-Young
415-209-2686
bernicl@sutterhealth.org

Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California 91505
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

City of Hope Comprehensive Cancer Center
Duarte, California 91010
Contact:
Kim A. Margolin
800-826-4673
becomingapatient@coh.org

Kaiser Permanente-Fontana
Fontana, California 92335
Contact:
Gary L. Buchschacher
626-564-3455

Kaiser Permanente-Fresno
Fresno, California 93720
Contact:
Tatjana Kolevska
510-891-3400

Kaiser Permanente - Harbor City
Harbor City, California 90710
Contact:
Gary L. Buchschacher
626-564-3455

Kaiser Permanente-Irvine
Irvine, California 92618
Contact:
Gary L. Buchschacher
626-564-3455

Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
Contact:
Gary L. Buchschacher
626-564-3455

Kaiser Permanente-Cadillac
Los Angeles, California 90034
Contact:
Gary L. Buchschacher
626-564-3455

UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California 90095
Contact:
Bartosz Chmielowski
888-798-0719

Palo Alto Medical Foundation-Camino Division
Mountain View, California 94040
Contact:
Jorge A. Garcia-Young
415-209-2686
bernicl@sutterhealth.org

Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View, California 94040
Contact:
Jorge A. Garcia-Young
415-209-2686
bernicl@sutterhealth.org

Sutter Cancer Research Consortium
Novato, California 94945
Contact:
Jorge A. Garcia-Young
415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente-Oakland
Oakland, California 94611
Contact:
Tatjana Kolevska
510-891-3400

Kaiser Permanente-Ontario
Ontario, California 91761
Contact:
Gary L. Buchschacher
626-564-3455

Palo Alto Medical Foundation Health Care
Palo Alto, California 94301
Contact:
Jorge A. Garcia-Young
415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente - Panorama City
Panorama City, California 91402
Contact:
Gary L. Buchschacher
626-564-3455

Feather River Cancer Center
Paradise, California 95969
Contact:
Sam Mazj
530-876-7995
haleew@ah.org

City of Hope Rancho Cucamonga
Rancho Cucamonga, California 91730
Contact:
Kim A. Margolin
800-826-4673
becomingapatient@coh.org

Eisenhower Medical Center
Rancho Mirage, California 92270
Contact:
Varun Gupta
760-834-3798

Kaiser Permanente-Richmond
Richmond, California 94801
Contact:
Tatjana Kolevska
510-891-3400

Kaiser Permanente-Riverside
Riverside, California 92505
Contact:
Gary L. Buchschacher
626-564-3455

Kaiser Permanente-Roseville
Roseville, California 95661
Contact:
Tatjana Kolevska
510-891-3400

Sutter Medical Center Sacramento
Sacramento, California 95816
Contact:
Jorge A. Garcia-Young
415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente - Sacramento
Sacramento, California 95825
Contact:
Tatjana Kolevska
510-891-3400

Kaiser Permanente-San Diego Mission
San Diego, California 92108
Contact:
Gary L. Buchschacher
626-564-3455

Kaiser Permanente-San Diego Zion
San Diego, California 92120
Contact:
Gary L. Buchschacher
626-564-3455

California Pacific Medical Center-Pacific Campus
San Francisco, California 94115
Contact:
Jorge A. Garcia-Young
415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente-San Marcos
San Marcos, California 92078
Contact:
Gary L. Buchschacher
626-564-3455

Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California 95051
Contact:
Tatjana Kolevska
510-891-3400

Kaiser Permanente-Stockton
Stockton, California 95210
Contact:
Tatjana Kolevska
510-891-3400

Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California 94086
Contact:
Jorge A. Garcia-Young
415-209-2686
bernicl@sutterhealth.org

Kaiser Permanente-Vallejo
Vallejo, California 94589
Contact:
Tatjana Kolevska
510-891-3400

Kaiser Permanente-Walnut Creek
Walnut Creek, California 94596
Contact:
Tatjana Kolevska
510-891-3400

Kaiser Permanente-Woodland Hills
Woodland Hills, California 91367
Contact:
Gary L. Buchschacher
626-564-3455

University of Colorado Hospital
Aurora, Colorado 80045
Contact:
Karl D. Lewis
720-848-0650

Penrose-Saint Francis Healthcare
Colorado Springs, Colorado 80907
Contact:
Mehmet S. Copur
501-622-2100

Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado 80907
Contact:
Mehmet S. Copur
501-622-2100

UCHealth Memorial Hospital Central
Colorado Springs, Colorado 80909
Contact:
Karl D. Lewis
720-848-0650

Porter Adventist Hospital
Denver, Colorado 80210
Contact:
Mehmet S. Copur
501-622-2100

SCL Health Saint Joseph Hospital
Denver, Colorado 80218
Contact:
Keren Sturtz
303-777-2663
ccrp@co-cancerresearch.org

Mercy Medical Center
Durango, Colorado 81301
Contact:
Mehmet S. Copur
501-622-2100

Southwest Oncology PC
Durango, Colorado 81301
Contact:
Mehmet S. Copur
501-622-2100

Comprehensive Cancer Care and Research Institute of Colorado LLC
Englewood, Colorado 80113
Contact:
Keren Sturtz
303-777-2663
ccrp@co-cancerresearch.org

Swedish Medical Center
Englewood, Colorado 80113
Contact:
Keren Sturtz
303-777-2663
ccrp@co-cancerresearch.org

Poudre Valley Hospital
Fort Collins, Colorado 80524
Contact:
Karl D. Lewis
720-848-0650

Mountain Blue Cancer Care Center
Golden, Colorado 80401
Contact:
Mehmet S. Copur
501-622-2100

North Colorado Medical Center
Greeley, Colorado 80631
Contact:
Keren Sturtz
303-777-2663
ccrp@co-cancerresearch.org

Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado 80228
Contact:
Mehmet S. Copur
501-622-2100

Saint Anthony Hospital
Lakewood, Colorado 80228
Contact:
Mehmet S. Copur
501-622-2100

Littleton Adventist Hospital
Littleton, Colorado 80122
Contact:
Mehmet S. Copur
501-622-2100

Longmont United Hospital
Longmont, Colorado 80501
Contact:
Mehmet S. Copur
501-622-2100

Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado 80501
Contact:
Mehmet S. Copur
501-622-2100

McKee Medical Center
Loveland, Colorado 80539
Contact:
Keren Sturtz
303-777-2663
ccrp@co-cancerresearch.org

Parker Adventist Hospital
Parker, Colorado 80138
Contact:
Mehmet S. Copur
501-622-2100

Rocky Mountain Cancer Centers-Parker
Parker, Colorado 80138
Contact:
Mehmet S. Copur
501-622-2100

Saint Mary Corwin Medical Center
Pueblo, Colorado 81004
Contact:
Mehmet S. Copur
501-622-2100

Rocky Mountain Cancer Centers - Pueblo
Pueblo, Colorado 81008
Contact:
Mehmet S. Copur
501-622-2100

Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado 80260
Contact:
Mehmet S. Copur
501-622-2100

Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut 06360
Contact:
Dennis E. Slater
860-886-8362

Stamford Hospital/Bennett Cancer Center
Stamford, Connecticut 06904
Contact:
Salvatore A. Del Prete
203-323-8944

MedStar Georgetown University Hospital
Washington, District of Columbia 20007
Contact:
Michael B. Atkins
202-444-2223

MedStar Washington Hospital Center
Washington, District of Columbia 20010
Contact:
Michael B. Atkins
202-444-2223

Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida 33180
Contact:
Michael A. Schwartz
888-823-5923
ctsucontact@westat.com

Halifax Health Medical Center-Centers for Oncology
Daytona Beach, Florida 32114
Contact:
Ruby Anne E. Deveras
888-823-5923
ctsucontact@westat.com

Mount Sinai Medical Center
Miami Beach, Florida 33140
Contact:
Michael A. Schwartz
305-674-2625
info@msccop.com

University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
Contact:
Lynn G. Feun
305-243-2647

University Cancer and Blood Center LLC
Athens, Georgia 30607
Contact:
Sharad A. Ghamande
706-353-5006
research@universitycancer.com

Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Contact:
David H. Lawson
404-778-1868

Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
Contact:
David H. Lawson
ecog.rss@jimmy.harvard.edu

Northside Hospital
Atlanta, Georgia 30342
Contact:
Ronald G. Steis
404-303-3355

Augusta University Medical Center
Augusta, Georgia 30912
Contact:
Sharad A. Ghamande
706-721-1663
cancer@augusta.edu

Northside Hospital-Forsyth
Cumming, Georgia 30041
Contact:
Ronald G. Steis
404-303-3355

Dekalb Medical Center
Decatur, Georgia 30033
Contact:
Sharad A. Ghamande
706-721-1663
cancer@augusta.edu

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia 31405
Contact:
Howard A. Zaren
912-819-5704

Hawaii Oncology Inc-Pali Momi
'Aiea, Hawaii 96701
Contact:
Jeffrey L. Berenberg
808-586-2979

Pali Momi Medical Center
'Aiea, Hawaii 96701
Contact:
Jeffrey L. Berenberg
808-486-6000

Hawaii Cancer Care Inc-POB II
Honolulu, Hawaii 96813
Contact:
Jeffrey L. Berenberg
808-586-2979

Hawaii Oncology Inc-POB I
Honolulu, Hawaii 96813
Contact:
Jeffrey L. Berenberg
808-586-2979

Queen's Medical Center
Honolulu, Hawaii 96813
Contact:
Jeffrey L. Berenberg
808-586-2979

Straub Clinic and Hospital
Honolulu, Hawaii 96813
Contact:
Jeffrey L. Berenberg
808-522-4333

University of Hawaii Cancer Center
Honolulu, Hawaii 96813
Contact:
Jeffrey L. Berenberg
808-586-2979

Hawaii Oncology Inc-Kuakini
Honolulu, Hawaii 96817
Contact:
Jeffrey L. Berenberg
808-586-2979

Kuakini Medical Center
Honolulu, Hawaii 96817
Contact:
Jeffrey L. Berenberg
808-586-2979

Kapiolani Medical Center for Women and Children
Honolulu, Hawaii 96826
Contact:
Jeffrey L. Berenberg
808-983-6090

Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii 96766
Contact:
Jeffrey L. Berenberg
808-535-7960

Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
Contact:
Christopher M. Reynolds
208-367-7954

Saint Luke's Mountain States Tumor Institute
Boise, Idaho 83712
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
Contact:
Christopher M. Reynolds
208-367-7954

Kootenai Medical Center
Coeur d'Alene, Idaho 83814
Contact:
Benjamin T. Marchello
406-969-6060
mccinfo@mtcancer.org

Walter Knox Memorial Hospital
Emmett, Idaho 83617
Contact:
Christopher M. Reynolds
208-367-7954

Saint Luke's Mountain States Tumor Institute - Fruitland
Fruitland, Idaho 83619
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Idaho Urologic Institute-Meridian
Meridian, Idaho 83642
Contact:
Christopher M. Reynolds
208-367-7954

Saint Luke's Mountain States Tumor Institute - Meridian
Meridian, Idaho 83642
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Saint Alphonsus Medical Center-Nampa
Nampa, Idaho 83686
Contact:
Christopher M. Reynolds
208-367-7954

Saint Luke's Mountain States Tumor Institute - Nampa
Nampa, Idaho 83686
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Kootenai Cancer Center
Post Falls, Idaho 83854
Contact:
Benjamin T. Marchello
406-969-6060
mccinfo@mtcancer.org

Kootenai Cancer Clinic
Sandpoint, Idaho 83864
Contact:
Benjamin T. Marchello
406-969-6060
mccinfo@mtcancer.org

Saint Luke's Mountain States Tumor Institute-Twin Falls
Twin Falls, Idaho 83301
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Rush - Copley Medical Center
Aurora, Illinois 60504
Contact:
Kendrith M. Rowland
630-978-6212
Cancer.Research@rushcopley.com

Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
Contact:
Bryan A. Faller
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Canton
Canton, Illinois 61520
Contact:
Bryan A. Faller
309-243-3605
andersonj@illinoiscancercare.com

Centralia Oncology Clinic
Centralia, Illinois 62801
Contact:
Bryan A. Faller
217-876-4740
rhamrick@dmhhs.org

Northwestern University
Chicago, Illinois 60611
Contact:
Sunandana Chandra
312-695-1301
cancer@northwestern.edu

Rush University Medical Center
Chicago, Illinois 60612
Contact:
Timothy M. Kuzel
312-942-5498
clinical_trials@rush.edu

Carle on Vermilion
Danville, Illinois 61832
Contact:
Kendrith M. Rowland
630-978-6212
Cancer.Research@rushcopley.com

Cancer Care Specialists of Central Illinois
Decatur, Illinois 62526
Contact:
Bryan A. Faller
217-876-4740
rhamrick@dmhhs.org

Decatur Memorial Hospital
Decatur, Illinois 62526
Contact:
Bryan A. Faller
217-876-4740
rhamrick@dmhhs.org

Carle Physician Group-Effingham
Effingham, Illinois 62401
Contact:
Kendrith M. Rowland
630-978-6212
Cancer.Research@rushcopley.com

Crossroads Cancer Center
Effingham, Illinois 62401
Contact:
Bryan A. Faller
217-876-4740
rhamrick@dmhhs.org

Illinois CancerCare-Eureka
Eureka, Illinois 61530
Contact:
Bryan A. Faller
309-243-3605
andersonj@illinoiscancercare.com

NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois 60201
Contact:
Bruce E. Brockstein
847-570-2109

Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
Contact:
Bryan A. Faller
309-243-3605
andersonj@illinoiscancercare.com

Western Illinois Cancer Treatment Center
Galesburg, Illinois 61401
Contact:
Bryan A. Faller
309-344-2831

Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
Contact:
John D. Ayers
847-827-9060

NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois 60026
Contact:
Bruce E. Brockstein
847-570-2109

NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois 60035
Contact:
Bruce E. Brockstein
847-570-2109

Illinois CancerCare-Macomb
Macomb, Illinois 61455
Contact:
Bryan A. Faller
309-243-3605
andersonj@illinoiscancercare.com

Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
Contact:
Kendrith M. Rowland
630-978-6212
Cancer.Research@rushcopley.com

Loyola University Medical Center
Maywood, Illinois 60153
Contact:
Joseph I. Clark
708-202-8387

Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
Contact:
Bryan A. Faller
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Pekin
Pekin, Illinois 61554
Contact:
Bryan A. Faller
309-243-3605
andersonj@illinoiscancercare.com

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois 61554
Contact:
Bryan A. Faller
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peoria
Peoria, Illinois 61615
Contact:
Bryan A. Faller
309-243-3605
andersonj@illinoiscancercare.com

OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois 61615
Contact:
Bryan A. Faller
309-243-3605
andersonj@illinoiscancercare.com

Methodist Medical Center of Illinois
Peoria, Illinois 61636
Contact:
Bryan A. Faller
309-243-3605
andersonj@illinoiscancercare.com

OSF Saint Francis Medical Center
Peoria, Illinois 61637
Contact:
Bryan A. Faller
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peru
Peru, Illinois 61354
Contact:
Bryan A. Faller
309-243-3605
andersonj@illinoiscancercare.com

Valley Radiation Oncology
Peru, Illinois 61354
Contact:
Bryan A. Faller
815-664-4141

Southern Illinois University School of Medicine
Springfield, Illinois 62702
Contact:
Bryan A. Faller
217-545-7929

Springfield Clinic
Springfield, Illinois 62702
Contact:
Bryan A. Faller
800-444-7541

Memorial Medical Center
Springfield, Illinois 62781
Contact:
Bryan A. Faller
217-788-3528

Cancer Care Specialists of Illinois-Swansea
Swansea, Illinois 62226
Contact:
Bryan A. Faller
217-876-4740
rhamrick@dmhhs.org

Carle Cancer Center
Urbana, Illinois 61801
Contact:
Kendrith M. Rowland
630-978-6212
Cancer.Research@rushcopley.com

The Carle Foundation Hospital
Urbana, Illinois 61801
Contact:
Kendrith M. Rowland
630-978-6212
Cancer.Research@rushcopley.com

Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
Contact:
John D. Ayers
847-827-9060

Rush-Copley Healthcare Center
Yorkville, Illinois 60560
Contact:
Kendrith M. Rowland
630-978-6212
Cancer.Research@rushcopley.com

Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
Contact:
Theodore F. Logan
888-342-7602

Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana 46202
Contact:
Theodore F. Logan
317-630-7808

Franciscan Health Indianapolis
Indianapolis, Indiana 46237
Contact:
Stephen E. Rubenstein
317-528-7060

Kendrick Colon and Rectal Center-Indianapolis
Indianapolis, Indiana 46237
Contact:
Stephen E. Rubenstein
317-528-7060

Franciscan Health Mooresville
Mooresville, Indiana 46158
Contact:
Stephen E. Rubenstein
317-528-7060

Mary Greeley Medical Center
Ames, Iowa 50010
Contact:
Joseph J. Merchant
515-239-2621

McFarland Clinic PC - Ames
Ames, Iowa 50010
Contact:
Joseph J. Merchant
515-239-2621

McFarland Clinic PC-Boone
Boone, Iowa 50036
Contact:
Joseph J. Merchant
515-239-2621

Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa 50325
Contact:
Mehmet S. Copur
501-622-2100

Mercy Cancer Center-West Lakes
Clive, Iowa 50325
Contact:
Mehmet S. Copur
501-622-2100

Alegent Health Mercy Hospital
Council Bluffs, Iowa 51503
Contact:
Mehmet S. Copur
501-622-2100

Greater Regional Medical Center
Creston, Iowa 50801
Contact:
Mehmet S. Copur
501-622-2100

Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa 50314
Contact:
Mehmet S. Copur
501-622-2100

Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
Contact:
Mehmet S. Copur
501-622-2100

McFarland Clinic PC-Trinity Cancer Center
Fort Dodge, Iowa 50501
Contact:
Joseph J. Merchant
515-239-2621

McFarland Clinic PC-Jefferson
Jefferson, Iowa 50129
Contact:
Joseph J. Merchant
515-239-2621

McFarland Clinic PC-Marshalltown
Marshalltown, Iowa 50158
Contact:
Joseph J. Merchant
515-239-2621

Siouxland Regional Cancer Center
Sioux City, Iowa 51101
Contact:
Donald B. Wender
712-252-0088

Mercy Medical Center-West Lakes
West Des Moines, Iowa 50266
Contact:
Mehmet S. Copur
501-622-2100

Cancer Center of Kansas - Chanute
Chanute, Kansas 66720
Contact:
Shaker R. Dakhil
316-268-5374

Cancer Center of Kansas - Dodge City
Dodge City, Kansas 67801
Contact:
Shaker R. Dakhil
316-268-5374

Cancer Center of Kansas - El Dorado
El Dorado, Kansas 67042
Contact:
Shaker R. Dakhil
316-268-5374

Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas 66701
Contact:
Shaker R. Dakhil
316-268-5374

Central Care Cancer Center - Garden City
Garden City, Kansas 67846
Contact:
Rakesh Gaur
913-948-5588
aroland@kccop.org

Central Care Cancer Center - Great Bend
Great Bend, Kansas 67530
Contact:
Gary C. Doolittle
913-948-5588
aroland@kccop.org

Hays Medical Center
Hays, Kansas 67601
Contact:
Gary C. Doolittle
913-945-7552
ctnursenav@kumc.edu

Cancer Center of Kansas-Independence
Independence, Kansas 67301
Contact:
Shaker R. Dakhil
316-268-5374

University of Kansas Cancer Center-West
Kansas City, Kansas 66112
Contact:
Gary C. Doolittle
913-945-7552
ctnursenav@kumc.edu

University of Kansas Cancer Center
Kansas City, Kansas 66160
Contact:
Gary C. Doolittle
913-945-7552
ctnursenav@kumc.edu

Cancer Center of Kansas-Kingman
Kingman, Kansas 67068
Contact:
Shaker R. Dakhil
316-268-5374

Lawrence Memorial Hospital
Lawrence, Kansas 66044
Contact:
Shaker R. Dakhil
316-268-5374

Cancer Center of Kansas-Liberal
Liberal, Kansas 67905
Contact:
Shaker R. Dakhil
316-268-5374

Cancer Center of Kansas-Manhattan
Manhattan, Kansas 66502
Contact:
Shaker R. Dakhil
316-268-5784

Cancer Center of Kansas - McPherson
McPherson, Kansas 67460
Contact:
Shaker R. Dakhil
316-268-5374

Cancer Center of Kansas - Newton
Newton, Kansas 67114
Contact:
Shaker R. Dakhil
316-268-5374

Olathe Medical Center
Olathe, Kansas 66061
Contact:
Gary C. Doolittle
913-945-7552
ctnursenav@kumc.edu

University of Kansas Cancer Center-Overland Park
Overland Park, Kansas 66210
Contact:
Gary C. Doolittle
913-945-7552
ctnursenav@kumc.edu

Cancer Center of Kansas - Parsons
Parsons, Kansas 67357
Contact:
Shaker R. Dakhil
316-268-5374

Cancer Center of Kansas - Pratt
Pratt, Kansas 67124
Contact:
Shaker R. Dakhil
316-268-5374

Cancer Center of Kansas - Salina
Salina, Kansas 67401
Contact:
Shaker R. Dakhil
316-268-5374

Salina Regional Health Center
Salina, Kansas 67401
Contact:
Gary C. Doolittle
913-945-7552
ctnursenav@kumc.edu

Saint Francis Hospital and Medical Center - Topeka
Topeka, Kansas 66606
Contact:
Gary C. Doolittle
913-945-7552
ctnursenav@kumc.edu

Cancer Center of Kansas - Wellington
Wellington, Kansas 67152
Contact:
Shaker R. Dakhil
316-268-5374

University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
Contact:
Gary C. Doolittle
913-945-7552
ctnursenav@kumc.edu

Associates In Womens Health
Wichita, Kansas 67208
Contact:
Shaker R. Dakhil
316-268-5374

Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas 67208
Contact:
Shaker R. Dakhil
316-268-5374

Cancer Center of Kansas - Wichita
Wichita, Kansas 67214
Contact:
Shaker R. Dakhil
316-268-5374

Via Christi Regional Medical Center
Wichita, Kansas 67214
Contact:
Shaker R. Dakhil
316-268-5374

Cancer Center of Kansas - Winfield
Winfield, Kansas 67156
Contact:
Shaker R. Dakhil
316-268-5374

Flaget Memorial Hospital
Bardstown, Kentucky 40004
Contact:
Mehmet S. Copur
501-622-2100

Commonwealth Cancer Center-Corbin
Corbin, Kentucky 40701
Contact:
Mehmet S. Copur
501-622-2100

Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky 40504
Contact:
Mehmet S. Copur
501-622-2100

Saint Joseph Hospital East
Lexington, Kentucky 40509
Contact:
Mehmet S. Copur
501-622-2100

Jewish Hospital
Louisville, Kentucky 40202
Contact:
Mehmet S. Copur
501-622-2100

The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky 40202
Contact:
Jason A. Chesney
502-562-3429

Saints Mary and Elizabeth Hospital
Louisville, Kentucky 40215
Contact:
Mehmet S. Copur
501-622-2100

Jewish Hospital Medical Center Northeast
Louisville, Kentucky 40245
Contact:
Mehmet S. Copur
501-622-2100

Jewish Hospital Medical Center South
Shepherdsville, Kentucky 40165
Contact:
Mehmet S. Copur
501-622-2100

LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana 70805
Contact:
David S. Hanson
225-215-1353
clinicalresearch@marybird.com

Louisiana Hematology Oncology Associates LLC
Baton Rouge, Louisiana 70809
Contact:
David S. Hanson
225-215-1353
clinicalresearch@marybird.com

Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana 70809
Contact:
David S. Hanson
225-215-1353
clinicalresearch@marybird.com

Our Lady of the Lake Physicians Group - Medical Oncology
Baton Rouge, Louisiana 70809
Contact:
David S. Hanson
225-215-1353
clinicalresearch@marybird.com

Northshore Oncology Associates-Covington
Covington, Louisiana 70433
Contact:
David S. Hanson
225-215-1353
clinicalresearch@marybird.com

Oncology Center of The South Incorporated
Houma, Louisiana 70360
Contact:
David S. Hanson
225-215-1353
clinicalresearch@marybird.com

Louisiana State University Health Science Center
New Orleans, Louisiana 70112
Contact:
Augusto C. Ochoa
504-568-2428
emede1@lsuhsc.edu

University Medical Center New Orleans
New Orleans, Louisiana 70112
Contact:
Augusto C. Ochoa
504-903-3000

Ochsner Medical Center Jefferson
New Orleans, Louisiana 70121
Contact:
Marc R. Matrana
504-842-3708

Greater Baltimore Medical Center
Baltimore, Maryland 21204
Contact:
Mei Tang
443-849-3706

Saint Agnes Hospital
Baltimore, Maryland 21229
Contact:
Carole B. Miller
410-368-2910

MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland 21237
Contact:
Michael B. Atkins
202-444-2223

Frederick Memorial Hospital
Frederick, Maryland 21701
Contact:
Mark G. Goldstein
240-566-3584
clinicaltrials@fmh.org

Hickman Cancer Center
Adrian, Michigan 49221
Contact:
Rex B. Mowat
517-265-0116

Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
Contact:
Christopher M. Reynolds
208-367-7954

University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
Contact:
Leslie A. Fecher
800-865-1125

Bronson Battle Creek
Battle Creek, Michigan 49017
Contact:
Kathleen J. Yost
616-391-1230
crcwm-regulatory@crcwm.org

IHA Hematology Oncology Consultants-Brighton
Brighton, Michigan 48114
Contact:
Christopher M. Reynolds
208-367-7954

Saint Joseph Mercy Brighton
Brighton, Michigan 48114
Contact:
Christopher M. Reynolds
208-367-7954

IHA Hematology Oncology Consultants-Canton
Canton, Michigan 48188
Contact:
Christopher M. Reynolds
208-367-7954

Saint Joseph Mercy Canton
Canton, Michigan 48188
Contact:
Christopher M. Reynolds
208-367-7954

Caro Cancer Center
Caro, Michigan 48723
Contact:
Christopher M. Reynolds
208-367-7954

IHA Hematology Oncology Consultants-Chelsea
Chelsea, Michigan 48118
Contact:
Christopher M. Reynolds
208-367-7954

Saint Joseph Mercy Chelsea
Chelsea, Michigan 48118
Contact:
Christopher M. Reynolds
208-367-7954

Hematology Oncology Consultants-Clarkston
Clarkston, Michigan 48346
Contact:
Christopher M. Reynolds
208-367-7954

Newland Medical Associates-Clarkston
Clarkston, Michigan 48346
Contact:
Christopher M. Reynolds
208-367-7954

Wayne State University/Karmanos Cancer Institute
Detroit, Michigan 48201
Contact:
Lawrence E. Flaherty
313-576-9363

Saint John Hospital and Medical Center
Detroit, Michigan 48236
Contact:
Christopher M. Reynolds
208-367-7954

Great Lakes Cancer Management Specialists-Doctors Park
East China Township, Michigan 48054
Contact:
Christopher M. Reynolds
208-367-7954

Green Bay Oncology - Escanaba
Escanaba, Michigan 49829
Contact:
Brian L. Burnette
920-433-8889
Christy.Gilchrist@hshs.org

Weisberg Cancer Treatment Center
Farmington Hills, Michigan 48334
Contact:
Lawrence E. Flaherty
313-576-9790
ctoadmin@karmanos.org

Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan 48503
Contact:
Christopher M. Reynolds
208-367-7954

Genesee Hematology Oncology PC
Flint, Michigan 48503
Contact:
Christopher M. Reynolds
208-367-7954

Genesys Hurley Cancer Institute
Flint, Michigan 48503
Contact:
Christopher M. Reynolds
208-367-7954

Hurley Medical Center
Flint, Michigan 48503
Contact:
Christopher M. Reynolds
208-367-7954

Mercy Health Saint Mary's
Grand Rapids, Michigan 49503
Contact:
Kathleen J. Yost
616-391-1230
crcwm-regulatory@crcwm.org

Spectrum Health at Butterworth Campus
Grand Rapids, Michigan 49503
Contact:
Kathleen J. Yost
616-391-1230
crcwm-regulatory@crcwm.org

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan 48236
Contact:
Christopher M. Reynolds
208-367-7954

Lymphoma Clinic of Michigan
Grosse Pointe Woods, Michigan 48236
Contact:
Christopher M. Reynolds
208-367-7954

Michigan Breast Specialists-Grosse Pointe Woods
Grosse Pointe Woods, Michigan 48236
Contact:
Christopher M. Reynolds
208-367-7954

Borgess Medical Center
Kalamazoo, Michigan 49001
Contact:
Kathleen J. Yost
616-391-1230
crcwm-regulatory@crcwm.org

West Michigan Cancer Center
Kalamazoo, Michigan 49007
Contact:
Kathleen J. Yost
616-391-1230
crcwm-regulatory@crcwm.org

Sparrow Hospital
Lansing, Michigan 48912
Contact:
Christopher M. Reynolds
208-367-7954

Hope Cancer Clinic
Livonia, Michigan 48154
Contact:
Christopher M. Reynolds
208-367-7954

Saint Mary Mercy Hospital
Livonia, Michigan 48154
Contact:
Christopher M. Reynolds
208-367-7954

Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, Michigan 48044
Contact:
Christopher M. Reynolds
208-367-7954

Michigan Breast Specialists-Macomb Township
Macomb, Michigan 48044
Contact:
Christopher M. Reynolds
208-367-7954

Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan 48453
Contact:
Christopher M. Reynolds
208-367-7954

Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan 48162
Contact:
Rex B. Mowat
517-265-0116

Mercy Health Mercy Campus
Muskegon, Michigan 49444
Contact:
Kathleen J. Yost
616-391-1230
crcwm-regulatory@crcwm.org

21st Century Oncology-Pontiac
Pontiac, Michigan 48341
Contact:
Christopher M. Reynolds
208-367-7954

Hope Cancer Center
Pontiac, Michigan 48341
Contact:
Christopher M. Reynolds
208-367-7954

Newland Medical Associates-Pontiac
Pontiac, Michigan 48341
Contact:
Christopher M. Reynolds
208-367-7954

Saint Joseph Mercy Oakland
Pontiac, Michigan 48341
Contact:
Christopher M. Reynolds
208-367-7954

Spectrum Health Reed City Hospital
Reed City, Michigan 49677
Contact:
Kathleen J. Yost
616-391-1230
crcwm-regulatory@crcwm.org

Great Lakes Cancer Management Specialists-Rochester Hills
Rochester Hills, Michigan 48309
Contact:
Christopher M. Reynolds
208-367-7954

Saint Mary's of Michigan
Saginaw, Michigan 48601
Contact:
Christopher M. Reynolds
208-367-7954

Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan 48604
Contact:
Christopher M. Reynolds
208-367-7954

Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, Michigan 48312
Contact:
Christopher M. Reynolds
208-367-7954

Saint Joseph Health System-Tawas City
Tawas City, Michigan 48764
Contact:
Christopher M. Reynolds
734-712-3671
stephanie.couch@stjoeshealth.org

Advanced Breast Care Center PLLC
Warren, Michigan 48088
Contact:
Christopher M. Reynolds
208-367-7954

Bhadresh Nayak MD PC-Warren
Warren, Michigan 48093
Contact:
Christopher M. Reynolds
208-367-7954

Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren, Michigan 48093
Contact:
Christopher M. Reynolds
208-367-7954

Macomb Hematology Oncology PC
Warren, Michigan 48093
Contact:
Christopher M. Reynolds
208-367-7954

Michigan Breast Specialists-Warren
Warren, Michigan 48093
Contact:
Christopher M. Reynolds
208-367-7954

Saint John Macomb-Oakland Hospital
Warren, Michigan 48093
Contact:
Christopher M. Reynolds
208-367-7954

Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan 48661
Contact:
Christopher M. Reynolds
208-367-7954

Metro Health Hospital
Wyoming, Michigan 49519
Contact:
Kathleen J. Yost
616-391-1230
crcwm-regulatory@crcwm.org

Huron Gastroenterology PC
Ypsilanti, Michigan 48106
Contact:
Christopher M. Reynolds
208-367-7954

IHA Hematology Oncology Consultants-Ann Arbor
Ypsilanti, Michigan 48197
Contact:
Christopher M. Reynolds
208-367-7954

Sanford Clinic North-Bemidgi
Bemidji, Minnesota 56601
Contact:
Preston D. Steen
712-252-0088

Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota 56401
Contact:
Bret E. Friday
888-203-7267

Mercy Hospital
Coon Rapids, Minnesota 55433
Contact:
David M. King
952-993-1517
mmcorc@healthpartners.com

Essentia Health Cancer Center
Duluth, Minnesota 55805
Contact:
Bret E. Friday
888-203-7267

Essentia Health Saint Mary's Medical Center
Duluth, Minnesota 55805
Contact:
Bret E. Friday
888-203-7267

Miller-Dwan Hospital
Duluth, Minnesota 55805
Contact:
Bret E. Friday
888-203-7267

Fairview-Southdale Hospital
Edina, Minnesota 55435
Contact:
David M. King
952-993-1517
mmcorc@healthpartners.com

Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota 56537
Contact:
Bret E. Friday
888-203-7267

Unity Hospital
Fridley, Minnesota 55432
Contact:
David M. King
952-993-1517
mmcorc@healthpartners.com

Adams Clinic
Hibbing, Minnesota 55746
Contact:
Bret E. Friday
ecog.rss@jimmy.harvard.edu

Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota 55109
Contact:
David M. King
952-993-1517
mmcorc@healthpartners.com

Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
Contact:
David M. King
952-993-1517
mmcorc@healthpartners.com

Hennepin County Medical Center
Minneapolis, Minnesota 55415
Contact:
David M. King
952-993-1517
mmcorc@healthpartners.com

Health Partners Inc
Minneapolis, Minnesota 55454
Contact:
David M. King
952-993-1517
mmcorc@healthpartners.com

North Memorial Medical Health Center
Robbinsdale, Minnesota 55422
Contact:
David M. King
952-993-1517
mmcorc@healthpartners.com

Regions Hospital
Saint Paul, Minnesota 55101
Contact:
David M. King
952-993-1517
mmcorc@healthpartners.com

United Hospital
Saint Paul, Minnesota 55102
Contact:
David M. King
952-993-1517
mmcorc@healthpartners.com

Saint Francis Regional Medical Center
Shakopee, Minnesota 55379
Contact:
David M. King
952-993-1517
mmcorc@healthpartners.com

Lakeview Hospital
Stillwater, Minnesota 55082
Contact:
David M. King
952-993-1517
mmcorc@healthpartners.com

Essentia Health Virginia Clinic
Virginia, Minnesota 55792
Contact:
Bret E. Friday
844-681-7944

Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota 55125
Contact:
David M. King
952-993-1517
mmcorc@healthpartners.com

Parkland Health Center-Bonne Terre
Bonne Terre, Missouri 63628
Contact:
Bryan A. Faller
314-996-5569

Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Contact:
Bryan A. Faller
573-334-2230
sfmc@sfmc.net

Southeast Cancer Center
Cape Girardeau, Missouri 63703
Contact:
Bryan A. Faller
573-651-5550

Capital Region Southwest Campus
Jefferson City, Missouri 65109
Contact:
Bryan A. Faller
573-632-4814
swooden@mail.crmc.org

Truman Medical Center
Kansas City, Missouri 64108
Contact:
Gary C. Doolittle
913-945-7552
ctnursenav@kumc.edu

Missouri Baptist Medical Center
Saint Louis, Missouri 63131
Contact:
Bryan A. Faller
314-996-5569

Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
Contact:
Bryan A. Faller
314-996-5569

Mercy Hospital Springfield
Springfield, Missouri 65804
Contact:
Jay W. Carlson
888-221-4849

CoxHealth South Hospital
Springfield, Missouri 65807
Contact:
Jay W. Carlson
888-221-4849

Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
Contact:
Bryan A. Faller
314-996-5569

Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri 63127
Contact:
Bryan A. Faller
314-996-5569

Community Hospital of Anaconda
Anaconda, Montana 59711
Contact:
Benjamin T. Marchello
406-969-6060
mccinfo@mtcancer.org

Bozeman Deaconess Hospital
Bozeman, Montana 59715
Contact:
Benjamin T. Marchello
406-969-6060
mccinfo@mtcancer.org

Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
Contact:
Benjamin T. Marchello
406-969-6060
mccinfo@mtcancer.org

Saint Peter's Community Hospital
Helena, Montana 59601
Contact:
Benjamin T. Marchello
406-969-6060
mccinfo@mtcancer.org

Kalispell Regional Medical Center
Kalispell, Montana 59901
Contact:
Benjamin T. Marchello
406-969-6060
mccinfo@mtcancer.org

Saint Patrick Hospital - Community Hospital
Missoula, Montana 59802
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Nebraska Medicine-Bellevue
Bellevue, Nebraska 68123
Contact:
Alissa S. Marr
402-559-6941
unmcrsa@unmc.edu

CHI Health Saint Francis
Grand Island, Nebraska 68803
Contact:
Mehmet S. Copur
501-622-2100

Heartland Hematology and Oncology
Kearney, Nebraska 68845
Contact:
Mehmet S. Copur
501-622-2100

CHI Health Good Samaritan
Kearney, Nebraska 68847
Contact:
Mehmet S. Copur
501-622-2100

Saint Elizabeth Regional Medical Center
Lincoln, Nebraska 68510
Contact:
Mehmet S. Copur
402-483-2827

Nebraska Methodist Hospital
Omaha, Nebraska 68114
Contact:
Ralph J. Hauke
402-354-5144

Nebraska Medicine-Village Pointe
Omaha, Nebraska 68118
Contact:
Alissa S. Marr
888-823-5923
ctsucontact@westat.com

Alegent Health Immanuel Medical Center
Omaha, Nebraska 68122
Contact:
Mehmet S. Copur
501-622-2100

Hematology and Oncology Consultants PC
Omaha, Nebraska 68122
Contact:
Mehmet S. Copur
501-622-2100

Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska 68124
Contact:
Mehmet S. Copur
501-622-2100

Nebraska Cancer Specialists - Omaha
Omaha, Nebraska 68124
Contact:
Gamini S. Soori
402-991-0070
mwilwerding@canceralliance-ne.org

Alegent Health Lakeside Hospital
Omaha, Nebraska 68130
Contact:
Mehmet S. Copur
501-622-2100

Creighton University Medical Center
Omaha, Nebraska 68131
Contact:
Mehmet S. Copur
501-622-2100

University of Nebraska Medical Center
Omaha, Nebraska 68198
Contact:
Alissa S. Marr
402-559-6941
unmcrsa@unmc.edu

Midlands Community Hospital
Papillion, Nebraska 68046
Contact:
Mehmet S. Copur
501-622-2100

Cancer and Blood Specialists-Henderson
Henderson, Nevada 89052
Contact:
John A. Ellerton
702-384-0013

Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada 89052
Contact:
John A. Ellerton
702-384-0013

Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada 89052
Contact:
John A. Ellerton
702-822-2000

Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada 89074
Contact:
John A. Ellerton
702-384-0013

University Medical Center of Southern Nevada
Las Vegas, Nevada 89102
Contact:
John A. Ellerton
702-384-0013

Cancer and Blood Specialists-Shadow
Las Vegas, Nevada 89106
Contact:
John A. Ellerton
702-384-0013

Ann M Wierman MD LTD
Las Vegas, Nevada 89128
Contact:
John A. Ellerton
702-384-0013

Cancer and Blood Specialists-Tenaya
Las Vegas, Nevada 89128
Contact:
John A. Ellerton
702-384-0013

Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada 89128
Contact:
John A. Ellerton
702-384-0013

Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada 89144
Contact:
John A. Ellerton
702-384-0013

Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89148
Contact:
John A. Ellerton
702-384-0013

Nevada Cancer Specialists-Fort Apache
Las Vegas, Nevada 89148
Contact:
John A. Ellerton
702-384-0013

Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada 89169
Contact:
John A. Ellerton
702-384-0013

Renown Regional Medical Center
Reno, Nevada 89502
Contact:
John A. Ellerton
702-384-0013

Saint Mary's Regional Medical Center
Reno, Nevada 89503
Contact:
John A. Ellerton
805-474-9143

Radiation Oncology Associates
Reno, Nevada 89509
Contact:
John A. Ellerton
702-384-0013

Hackensack University Medical Center
Hackensack, New Jersey 07601
Contact:
Donna T. McNamara
201-996-2879

University of New Mexico Cancer Center
Albuquerque, New Mexico 87102
Contact:
Ian Rabinowitz
505-925-0366
LByatt@nmcca.org

New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico 87109
Contact:
Ian Rabinowitz
505-925-0366
LByatt@nmcca.org

Memorial Medical Center - Las Cruces
Las Cruces, New Mexico 88011
Contact:
Ian Rabinowitz
575-556-6545
Kim.Hoffman@lpnt.net

Presbyterian Rust Medical Center/Jorgensen Cancer Center
Rio Rancho, New Mexico 87124
Contact:
Ian Rabinowitz
505-559-6113
WBurman@phs.org

Roswell Park Cancer Institute
Buffalo, New York 14263
Contact:
Marc S. Ernstoff
877-275-7724

Mary Imogene Bassett Hospital
Cooperstown, New York 13326
Contact:
Eric Bravin
607-547-3073
diana.crean@bassett.org

University of Rochester
Rochester, New York 14642
Contact:
Paul M. Barr
585-275-5830

State University of New York Upstate Medical University
Syracuse, New York 13210
Contact:
Rahul Seth
315-464-5476

Asheville Hematology-Oncology Associates
Asheville, North Carolina 28803
Contact:
Raymond Thertulien
828-213-4150

Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina 28328
Contact:
James N. Atkins
252-399-7491

Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina 27534
Contact:
James N. Atkins
252-399-7491

Wayne Memorial Hospital
Goldsboro, North Carolina 27534
Contact:
James N. Atkins
252-399-7491

Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina 28791
Contact:
James E. Radford
828-696-1341

Onslow Memorial Hospital
Jacksonville, North Carolina 28546
Contact:
James N. Atkins
252-399-7491

Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina 28546
Contact:
James N. Atkins
252-399-7491

Kinston Medical Specialists PA
Kinston, North Carolina 28501
Contact:
Peter R. Watson
252-559-2200

Southeast Clinical Oncology Research (SCOR) Consortium NCORP
Winston-Salem, North Carolina 27104
Contact:
Asheesh Shipstone
423-578-8538

Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
Contact:
Preston D. Steen
712-252-0088

Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota 58103
Contact:
Bret E. Friday
888-203-7267

Roger Maris Cancer Center
Fargo, North Dakota 58122
Contact:
Preston D. Steen
712-252-0088

Sanford Broadway Medical Center
Fargo, North Dakota 58122
Contact:
Preston D. Steen
712-252-0088

Sanford Clinic North-Fargo
Fargo, North Dakota 58122
Contact:
Preston D. Steen
712-252-0088

UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio 44122
Contact:
Henry B. Koon
800-641-2422

Dayton Physicians LLC-Miami Valley South
Centerville, Ohio 45459
Contact:
Howard M. Gross
937-775-1350
som_dcop@wright.edu

Miami Valley Hospital South
Centerville, Ohio 45459
Contact:
Howard M. Gross
937-775-1350
som_dcop@wright.edu

University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio 45219
Contact:
Nagla Abdel Karim
800-293-5066
Jamesline@osumc.edu

Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio 45220
Contact:
Mehmet S. Copur
501-622-2100

Bethesda North Hospital
Cincinnati, Ohio 45242
Contact:
Mehmet S. Copur
501-622-2100

TriHealth Cancer Institute-Westside
Cincinnati, Ohio 45247
Contact:
Mehmet S. Copur
501-622-2100

TriHealth Cancer Institute-Anderson
Cincinnati, Ohio 45255
Contact:
Mehmet S. Copur
501-622-2100

Case Western Reserve University
Cleveland, Ohio 44106
Contact:
Henry B. Koon
800-641-2422

MetroHealth Medical Center
Cleveland, Ohio 44109
Contact:
Bruce J. Averbook
216-778-8526
kbauchens@metrohealth.org

Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio 44111
Contact:
Ahmad Tarhini
866-223-8100

Cleveland Clinic Foundation
Cleveland, Ohio 44195
Contact:
Ahmad Tarhini
866-223-8100

Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Contact:
Joanne M. Jeter
800-293-5066
Jamesline@osumc.edu

Columbus Oncology and Hematology Associates Inc
Columbus, Ohio 43214
Contact:
Timothy D. Moore
614-488-2745
sheree@columbusccop.org

Riverside Methodist Hospital
Columbus, Ohio 43214
Contact:
Timothy D. Moore
614-488-2745
sheree@columbusccop.org

Grant Medical Center
Columbus, Ohio 43215
Contact:
Timothy D. Moore
614-566-4475

Good Samaritan Hospital - Dayton
Dayton, Ohio 45406
Contact:
Howard M. Gross
937-775-1350
som_dcop@wright.edu

Miami Valley Hospital
Dayton, Ohio 45409
Contact:
Howard M. Gross
937-775-1350
som_dcop@wright.edu

Dayton Physicians LLC-Samaritan North
Dayton, Ohio 45415
Contact:
Howard M. Gross
937-775-1350
som_dcop@wright.edu

Samaritan North Health Center
Dayton, Ohio 45415
Contact:
Howard M. Gross
937-775-1350
som_dcop@wright.edu

Dayton Physicians LLC-Atrium
Franklin, Ohio 45005
Contact:
Howard M. Gross
937-775-1350
som_dcop@wright.edu

Dayton Physicians LLC-Wayne
Greenville, Ohio 45331
Contact:
Howard M. Gross
937-775-1350
som_dcop@wright.edu

Wayne Hospital
Greenville, Ohio 45331
Contact:
Howard M. Gross
937-775-1350
som_dcop@wright.edu

Greater Dayton Cancer Center
Kettering, Ohio 45409
Contact:
Howard M. Gross
937-775-1350
som_dcop@wright.edu

Kettering Medical Center
Kettering, Ohio 45429
Contact:
Howard M. Gross
937-775-1350
som_dcop@wright.edu

Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio 43537
Contact:
Rex B. Mowat
517-265-0116

Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio 43537
Contact:
Rex B. Mowat
517-265-0116

Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio 44124
Contact:
Ahmad Tarhini
866-223-8100

Licking Memorial Hospital
Newark, Ohio 43055
Contact:
Timothy D. Moore
614-488-2745
sheree@columbusccop.org

Newark Radiation Oncology
Newark, Ohio 43055
Contact:
Timothy D. Moore
614-488-2745
sheree@columbusccop.org

Mercy Health Perrysburg Cancer Center
Perrysburg, Ohio 43551
Contact:
Rex B. Mowat
517-265-0116

Southern Ohio Medical Center
Portsmouth, Ohio 45662
Contact:
Timothy D. Moore
614-488-2745
sheree@columbusccop.org

North Coast Cancer Care
Sandusky, Ohio 44870
Contact:
Ahmad Tarhini
866-223-8100

Mercy Saint Anne Hospital
Toledo, Ohio 43623
Contact:
Rex B. Mowat
517-265-0116

Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio 43623
Contact:
Rex B. Mowat
517-265-0116

Dayton Physicians LLC-Upper Valley
Troy, Ohio 45373
Contact:
Howard M. Gross
937-775-1350
som_dcop@wright.edu

Upper Valley Medical Center
Troy, Ohio 45373
Contact:
Howard M. Gross
937-775-1350
som_dcop@wright.edu

University Pointe
West Chester, Ohio 45069
Contact:
Nagla Abdel Karim
800-293-5066
Jamesline@osumc.edu

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Contact:
Alexandra P. Ikeguchi
405-271-8777
ou-clinical-trials@ouhsc.edu

Saint Alphonsus Medical Center-Baker City
Baker City, Oregon 97814
Contact:
Christopher M. Reynolds
208-367-7954

Saint Charles Health System
Bend, Oregon 97701
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Clackamas Radiation Oncology Center
Clackamas, Oregon 97015
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Providence Oncology and Hematology Care Southeast
Clackamas, Oregon 97015
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Bay Area Hospital
Coos Bay, Oregon 97420
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Providence Newberg Medical Center
Newberg, Oregon 97132
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Saint Alphonsus Medical Center-Ontario
Ontario, Oregon 97914
Contact:
Christopher M. Reynolds
208-367-7954

Providence Portland Medical Center
Portland, Oregon 97213
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Providence Saint Vincent Medical Center
Portland, Oregon 97225
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania 18103
Contact:
Christopher M. Reynolds
208-367-7954

UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania 15009
Contact:
Diwakar Davar
412-692-2001

Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania 18015
Contact:
Sanjiv S. Agarwala
ecog.rss@jimmy.harvard.edu

Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania 18017
Contact:
Christopher M. Reynolds
208-367-7954

Geisinger Medical Center
Danville, Pennsylvania 17822
Contact:
Joseph J. Vadakara
570-271-5251

UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania 15601
Contact:
Diwakar Davar
412-692-2001

UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania 15901
Contact:
Diwakar Davar
412-692-2001

Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania 17837
Contact:
Joseph J. Vadakara
570-271-5251

UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania 15132
Contact:
Diwakar Davar
412-692-2001

UPMC-Coraopolis/Heritage Valley Radiation Oncology
Moon, Pennsylvania 15108
Contact:
Diwakar Davar
412-692-2001

Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
Contact:
Larisa Greenberg
877-284-2000

UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania 15213
Contact:
Diwakar Davar
412-692-2001

UPMC-Presbyterian Hospital
Pittsburgh, Pennsylvania 15213
Contact:
Diwakar Davar
412-692-2001

UPMC-Saint Margaret
Pittsburgh, Pennsylvania 15215
Contact:
Diwakar Davar
412-692-2001

West Penn Hospital
Pittsburgh, Pennsylvania 15224
Contact:
Larisa Greenberg
877-284-2000

University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
Contact:
Diwakar Davar
412-692-2001

UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania 15232
Contact:
Diwakar Davar
412-692-2001

UPMC-Passavant Hospital
Pittsburgh, Pennsylvania 15237
Contact:
Diwakar Davar
412-692-2001

UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania 15243
Contact:
Diwakar Davar
412-692-2001

Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania 18840
Contact:
Philip A. Lowry
800-836-0388

UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania 16346
Contact:
Diwakar Davar
412-692-2001

UPMC Uniontown Hospital Radiation Oncology
Uniontown, Pennsylvania 15401
Contact:
Diwakar Davar
412-692-2001

UPMC Washington Hospital Radiation Oncology
Washington, Pennsylvania 15301
Contact:
Diwakar Davar
412-692-2001

Reading Hospital
West Reading, Pennsylvania 19611
Contact:
Terrence P. Cescon
610-988-9323

Wexford Health and Wellness Pavilion
Wexford, Pennsylvania 15090
Contact:
Larisa Greenberg
877-284-2000

Medical University of South Carolina
Charleston, South Carolina 29425
Contact:
Daniel Y. Reuben
843-792-9321

Greenville Health System Cancer Institute-Easley
Easley, South Carolina 29640
Contact:
Jeffrey K. Giguere
864-679-3966

Saint Francis Hospital
Greenville, South Carolina 29601
Contact:
Robert D. Siegel
864-255-1713

Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina 29605
Contact:
Jeffrey K. Giguere
864-679-3966

Greenville Health System Cancer Institute-Faris
Greenville, South Carolina 29605
Contact:
Jeffrey K. Giguere
864-679-3966

Greenville Memorial Hospital
Greenville, South Carolina 29605
Contact:
Jeffrey K. Giguere
864-679-3966

Saint Francis Cancer Center
Greenville, South Carolina 29607
Contact:
Robert D. Siegel
864-255-1713

Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina 29615
Contact:
Jeffrey K. Giguere
864-679-3966

Greenville Health System Cancer Institute-Greer
Greer, South Carolina 29650
Contact:
Jeffrey K. Giguere
864-679-3966

The Radiation Oncology Center-Hilton Head/Bluffton
Hilton Head Island, South Carolina 29926
Contact:
Howard A. Zaren
912-819-5704

Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina 29672
Contact:
Jeffrey K. Giguere
864-679-3966

Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina 29307
Contact:
Jeffrey K. Giguere
864-679-3966

Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
Contact:
Preston D. Steen
712-252-0088

Avera Cancer Institute
Sioux Falls, South Dakota 57105
Contact:
Benjamin M. Solomon
888-634-7268
oncregulatory@avera.org

Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
Contact:
Preston D. Steen
712-252-0088

Erlanger Medical Center
Chattanooga, Tennessee 37403
Contact:
Larry L. Schlabach
423-778-6947

Memorial Hospital
Chattanooga, Tennessee 37404
Contact:
Mehmet S. Copur
501-622-2100

Vanderbilt-Ingram Cancer Center Cool Springs
Franklin, Tennessee 37067
Contact:
Kristin K. Ancell
800-811-8480

Pulmonary Medicine Center of Chattanooga-Hixson
Hixson, Tennessee 37343
Contact:
Mehmet S. Copur
501-622-2100

Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee 37660
Contact:
Asheesh Shipstone
423-224-5593

Wellmont Medical Associates Oncology and Hematology-Kingsport
Kingsport, Tennessee 37660
Contact:
Asheesh Shipstone
423-224-5593

Thompson Cancer Survival Center
Knoxville, Tennessee 37916
Contact:
Wenqing Zhang
630-978-6212
Cancer.Research@rushcopley.com

Thompson Cancer Survival Center - West
Knoxville, Tennessee 37932
Contact:
Wenqing Zhang
630-978-6212
Cancer.Research@rushcopley.com

Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee 37204
Contact:
Kristin K. Ancell
800-811-8480

Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
Contact:
Kristin K. Ancell
800-811-8480

Thompson Oncology Group-Oak Ridge
Oak Ridge, Tennessee 37830
Contact:
Wenqing Zhang
630-978-6212
Cancer.Research@rushcopley.com

Memorial GYN Plus
Ooltewah, Tennessee 37363
Contact:
Mehmet S. Copur
501-622-2100

Saint Joseph Regional Cancer Center
Bryan, Texas 77802
Contact:
Mehmet S. Copur
501-622-2100

Southwest VA Regional Cancer Center
Norton, Virginia 24273
Contact:
Asheesh Shipstone
423-224-5593

Providence Regional Cancer System-Aberdeen
Aberdeen, Washington 98520
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

MultiCare Auburn Medical Center
Auburn, Washington 98001
Contact:
John A. Keech
907-458-5380

Virginia Mason Bainbridge Island Medical Center
Bainbridge Island, Washington 98110
Contact:
John A. Keech
907-458-5380

Overlake Hospital Medical Center
Bellevue, Washington 98004
Contact:
John A. Keech
907-458-5380

PeaceHealth Saint Joseph Medical Center
Bellingham, Washington 98225
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington 98310
Contact:
Mehmet S. Copur
308-398-6518
clinicaltrials@sfmc-gi.org

Harrison Medical Center
Bremerton, Washington 98310
Contact:
Mehmet S. Copur
308-398-6518
clinicaltrials@sfmc-gi.org

Highline Medical Center-Main Campus
Burien, Washington 98166
Contact:
Mehmet S. Copur
501-622-2100

Providence Regional Cancer System-Centralia
Centralia, Washington 98531
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Swedish Medical Center-Edmonds
Edmonds, Washington 98026
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Saint Elizabeth Hospital
Enumclaw, Washington 98022
Contact:
Mehmet S. Copur
501-622-2100

Providence Regional Cancer Partnership
Everett, Washington 98201
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Virginia Mason Federal Way Medical Center
Federal Way, Washington 98002
Contact:
John A. Keech
907-458-5380

Saint Francis Hospital
Federal Way, Washington 98003
Contact:
Mehmet S. Copur
501-622-2100

Tacoma/Valley Radiation Oncology Centers-Gig Harbor
Gig Harbor, Washington 98332
Contact:
John A. Keech
907-458-5380

MultiCare Gig Harbor Medical Park
Gig Harbor, Washington 98335
Contact:
John A. Keech
907-458-5380

Swedish Cancer Institute-Issaquah
Issaquah, Washington 98029
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Northwest Cancer Clinic
Kennewick, Washington 99336
Contact:
John A. Keech
509-987-1800
info@tacomaradiation.com

Providence Regional Cancer System-Lacey
Lacey, Washington 98503
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Saint Clare Hospital
Lakewood, Washington 98499
Contact:
Mehmet S. Copur
501-622-2100

PeaceHealth Saint John Medical Center
Longview, Washington 98632
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Virginia Mason Lynnwood Medical Center
Lynnwood, Washington 98036
Contact:
John A. Keech
907-458-5380

Jefferson Healthcare
Port Townsend, Washington 98368
Contact:
John A. Keech
907-458-5380

Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington 98370
Contact:
Mehmet S. Copur
308-398-6518
clinicaltrials@sfmc-gi.org

Peninsula Cancer Center
Poulsbo, Washington 98370
Contact:
John A. Keech
907-458-5380

MultiCare Good Samaritan Hospital
Puyallup, Washington 98372
Contact:
John A. Keech
907-458-5380

Tacoma/Valley Radiation Oncology Centers-Puyallup
Puyallup, Washington 98372
Contact:
John A. Keech
907-458-5380

Valley Medical Center
Renton, Washington 98055
Contact:
John A. Keech
907-458-5380

Virginia Mason Medical Center
Seattle, Washington 98101
Contact:
John A. Keech
907-458-5380

Pacific Gynecology Specialists
Seattle, Washington 98104
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Swedish Medical Center-Ballard Campus
Seattle, Washington 98107
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Kaiser Permanente Washington
Seattle, Washington 98112
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Swedish Medical Center-First Hill
Seattle, Washington 98122-4307
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Swedish Medical Center-Cherry Hill
Seattle, Washington 98122-5711
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Providence Regional Cancer System-Shelton
Shelton, Washington 98584
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Tacoma/Valley Radiation Oncology Centers-Jackson Hall
Tacoma, Washington 97405
Contact:
John A. Keech
907-458-5380

Franciscan Research Center-Northwest Medical Plaza
Tacoma, Washington 98405
Contact:
Mehmet S. Copur
501-622-2100

MultiCare Tacoma General Hospital
Tacoma, Washington 98405
Contact:
John A. Keech
907-458-5380

Northwest Medical Specialties PLLC
Tacoma, Washington 98405
Contact:
Mehmet S. Copur
501-622-2100

Northwest NCI Community Oncology Research Program
Tacoma, Washington 98405
Contact:
John A. Keech
253-403-2394

Tacoma/Valley Radiation Oncology Centers-Saint Joe's
Tacoma, Washington 98405
Contact:
John A. Keech
907-458-5380

PeaceHealth Southwest Medical Center
Vancouver, Washington 98664
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Providence Saint Mary Regional Cancer Center
Walla Walla, Washington 99362
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Providence Regional Cancer System-Yelm
Yelm, Washington 98597
Contact:
Alison K. Conlin
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

West Virginia University Charleston
Charleston, West Virginia 25304
Contact:
Steven J. Jubelirer
304-388-9944

Edwards Comprehensive Cancer Center
Huntington, West Virginia 25701
Contact:
Maria R. Tria Tirona
304-399-6617

West Virginia University Healthcare
Morgantown, West Virginia 26506
Contact:
Inderjit Mehmi
304-293-7374
cancertrialsinfo@hsc.wvu.edu

Langlade Hospital and Cancer Center
Antigo, Wisconsin 54409
Contact:
Harish G. Ahuja
877-405-6866

Duluth Clinic Ashland
Ashland, Wisconsin 54806
Contact:
Bret E. Friday
ecog.rss@jimmy.harvard.edu

Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin 54729
Contact:
Seth O. Fagbemi
800-347-0673

Marshfield Clinic Cancer Center - Eau Claire
Eau Claire, Wisconsin 54701
Contact:
Seth O. Fagbemi
800-924-8515

Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin 54301-3526
Contact:
Brian L. Burnette
920-433-8889

Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin 54301
Contact:
Brian L. Burnette
920-433-8889
Christy.Gilchrist@hshs.org

Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin 54303
Contact:
Brian L. Burnette
920-433-8889

Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin 54303
Contact:
Brian L. Burnette
920-433-8889
Christy.Gilchrist@hshs.org

Gundersen Lutheran Medical Center
La Crosse, Wisconsin 54601
Contact:
Kurt Oettel
608-775-2385
cancerctr@gundersenhealth.org

University of Wisconsin Hospital and Clinics
Madison, Wisconsin 53792
Contact:
Mark R. Albertini
608-256-1901

Holy Family Memorial Hospital
Manitowoc, Wisconsin 54221
Contact:
Brian L. Burnette
920-433-8889
Christy.Gilchrist@hshs.org

Saint Vincent Hospital Cancer Center at Marinette
Marinette, Wisconsin 54143
Contact:
Brian L. Burnette
920-433-8889
Christy.Gilchrist@hshs.org

Marshfield Clinic
Marshfield, Wisconsin 54449
Contact:
Seth O. Fagbemi
800-347-0673

Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Contact:
Amy K. Harker-Murray
214-648-7097

Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin 54548
Contact:
Seth O. Fagbemi
800-347-0673

Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin 54154
Contact:
Brian L. Burnette
920-433-8889
Christy.Gilchrist@hshs.org

Lakeview Medical Center-Marshfield Clinic
Rice Lake, Wisconsin 54868
Contact:
Seth O. Fagbemi
715-236-8100

Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin 54868
Contact:
Seth O. Fagbemi
800-347-0673

HSHS Saint Nicholas Hospital
Sheboygan, Wisconsin 53081
Contact:
Brian L. Burnette
920-433-8889
Christy.Gilchrist@hshs.org

Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin 54482
Contact:
Seth O. Fagbemi
855-829-8555

Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin 54235-1495
Contact:
Brian L. Burnette
920-433-8889
Christy.Gilchrist@hshs.org

Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin 54235
Contact:
Brian L. Burnette
920-433-8889

Aspirus Regional Cancer Center
Wausau, Wisconsin 54401
Contact:
Harish G. Ahuja
877-405-6866

Marshfield Clinic-Wausau Center
Wausau, Wisconsin 54401
Contact:
Seth O. Fagbemi
800-847-0016

Marshfield Clinic - Weston Center
Weston, Wisconsin 54476
Contact:
Seth O. Fagbemi
715-393-1400

Aspirus UW Cancer Center
Wisconsin Rapids, Wisconsin 54494
Contact:
Harish G. Ahuja
877-405-6866

Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin 54494
Contact:
Seth O. Fagbemi
800-656-0664

More Details

NCT ID
NCT02224781
Status
Recruiting
Sponsor
National Cancer Institute (NCI)

Detailed Description

PRIMARY OBJECTIVES:

I. To determine whether initial treatment with either combination ipilimumab + nivolumab (with subsequent dabrafenib in combination with trametinib) or dabrafenib in combination with trametinib (with subsequent ipilimumab + nivolumab) significantly improves 2 year overall survival (OS) in patients with unresectable stage III or stage IV BRAFV600 mutant melanoma.

SECONDARY OBJECTIVES:

I. To evaluate the impact of initial treatment on median OS and hazard ratio for death.

II. To determine whether initial treatment choice significantly improves 3 year OS.

III. To evaluate the anti-tumor activities (Response Evaluation Criteria in Solid Tumors [RECIST]-defined response rate, median progression-free survival [PFS]) and safety profiles of ipilimumab + nivolumab and dabrafenib-trametinib in a Cooperative Group trial of patients with V600 mutant melanoma.

IV. To evaluate the activity (RECIST-defined response rate, median PFS) and safety of dabrafenib-trametinib in patients who have had disease progression on ipilimumab + nivolumab and in comparison to its activity and safety in ipilimumab + nivolumab naive patients.

V. To evaluate the activity of ipilimumab + nivolumab (RECIST-defined response rate, median PFS) and safety in patients who have had disease progression on dabrafenib + trametinib and in comparison to its activity and safety in dabrafenib + trametinib naive patients.

VI. To assess the feasibility of crossover to the alternative treatment strategy (percentage of patients who are able to crossover from one arm to the other and complete at least an initial course of treatment after cross-over without intervening symptomatic disease progression or treatment limiting toxicity).

VII. Association of inherited variation with immune mediated adverse events and response to ipilimumab + nivolumab.

VIII. To determine the association of inherited genetic variation and immune-associated adverse events in patients with metastatic melanoma treated with ipilimumab containing regimens by completing candidate-based gene and pathway analyses of genes involved in lymphocyte activation, cytokines, cytokine receptors and within the major histocompatibility complex (MHC) region and an agnostic genome-wide single nucleotide polymorphism (SNP)-based approach.

IX. To investigate the association between inherited genetics and survival in patients with metastatic melanoma treated with ipilimumab containing regimens by completing candidate-based gene and pathway analyses of genes involved in lymphocyte activation, cytokines profile, cytokine receptors and within the MHC region and an agnostic genome-wide SNP-based approach.

X. To replicate genomic markers identified in the above aims in an independent sample set of patients treated with ipilimumab containing regimens and preliminarily characterize their potential functional role by completing replication of variation as associated with immune-related adverse events (irAEs) and survival and bio-informatic assessment of genomic markers.

XI. To determine the utility of circulating BRAF levels in determining the response and resistance to either BRAF/MEK directed and/or combination immunotherapy in patients with BRAF mutant melanoma.

XII. To determine if changes in blood BRAF levels utilizing peripheral blood BRAFV600 mutational testing in patients with stage IV BRAF mutant melanoma correlate with response and resistance to combination BRAF/MEK directed therapy.

XIII. To determine if changes in blood BRAF levels utilizing peripheral blood BRAFV600 mutational testing in patients with stage IV BRAF mutant melanoma correlate with response and resistance to combination immunotherapy.

XIV. To compare the kinetics of peripheral blood BRAFV600 levels during response and resistance in groups of patients receiving BRAF targeted therapy or combination immunotherapy as initial therapy.

XV. To compare the kinetics of peripheral blood BRAFV600 levels during response and resistance to combination BRAF targeted therapy or combination immunotherapy in individual patients (initial treatment vs crossover treatment).

PATIENT REPORTED OUTCOMES OBJECTIVES:

I. To evaluate differences in overall health between initial treatment arms (dabrafenib + trametinib vs. ipilimumab + nivolumab immunotherapy) at 2 years, accounting for toxicities and overall survival. (Primary) II. To assess differences in overall function over 2 years between initial treatment with dabrafenib + trametinib vs. ipilimumab + nivolumab. (Secondary) III. To document the effects of treatment crossover and treatment administration sequence on symptom burden and overall function. (Secondary) IV. To compare differences in function and symptoms by treatment sequence for ipilimumab + nivolumab (arm A vs. D), and dabrafenib + trametinib, (arm B vs. C) at baseline, 6 weeks, 12 weeks, and 6 months after the initiation of each treatment.

V. To describe the frequency and severity of treatment toxicities at baseline, 6 weeks, 12 weeks, and 6 months after initiation of each treatment.

TERTIARY OBJECTIVES:

I. To determine the effects of tobacco, operationalized as combustible tobacco (1a), other forms of tobacco (1b), and environmental tobacco exposure (ETS) (1c) on provider-reported cancer-treatment toxicity (adverse events [both clinical and hematologic] and dose modifications).

II. To determine the effects of tobacco on patient-reported physical symptoms and psychological symptoms.

III. To examine quitting behaviors and behavioral counseling/support and cessation medication utilization.

IV. To explore the effect of tobacco use and exposure on treatment duration, relative dose intensity, and therapeutic benefit.

OUTLINE: Patients are randomized to 1 of 2 treatment arms (Arm A or Arm B).

ARM A:

IMMUNOTHERAPY INDUCTION (COURSES 1-2): Patients receive nivolumab intravenously (IV) over 60 minutes and ipilimumab IV over 90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

IMMUNOTHERAPY MAINTENANCE (COURSES 3-14): Patients receive nivolumab IV over 60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients re-register and cross over to Arm C.

ARM C: Patients receive dabrafenib orally (PO) twice daily (BID) and trametinib PO daily on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive dabrafenib PO BID and trametinib PO daily on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients re-register and cross over to Arm D.

ARM D:

IMMUNOTHERAPY INDUCTION (COURSES 1-2): Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

IMMUNOTHERAPY MAINTENANCE (COURSES 3-14): Patients receive nivolumab IV over 60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.