Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Stage IIIB-IV Melanoma, The PET-Stop Trial

Purpose

This phase II trial investigates how well biomarkers on PET/CT imaging drive early discontinuation of anti-PD-1 therapy in patients with stage IIIB-IV melanoma that cannot be removed by surgery (unresectable). Anti-PD-1 therapy has become a standard therapy option for patients with unresectable melanoma. This trial is being done to determine if doctors can safely shorten the use of standard of care anti-PD1 therapy for melanoma by using biomarkers seen on PET/CT imaging and tumor biopsy.

Conditions

  • Advanced Melanoma
  • Clinical Stage III Cutaneous Melanoma AJCC v8
  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Melanoma of Unknown Primary
  • Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
  • Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
  • Pathologic Stage IIID Cutaneous Melanoma AJCC v8
  • Pathologic Stage IV Cutaneous Melanoma AJCC v8
  • Unresectable Acral Lentiginous Melanoma
  • Unresectable Melanoma
  • Unresectable Mucosal Melanoma

Eligibility

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

Inclusion Criteria

  • STEP 0 PRE-REGISTRATION INCLUSION CRITERIA - Patient must have active advanced melanoma, defined as unresectable stage IIIB-IV by American Joint Committee on Cancer (AJCC) 8th edition - Patient must have melanoma originating from cutaneous, acral-lentiginous, or mucosal primary sites. Patients with melanoma of unknown primary site are eligible. Patients must not have melanoma from an ocular primary site - Patient must have had measurable disease by immune related Response Evaluation Criteria in Solid Tumors (imRECIST) prior to start of initial anti-PD-1 therapy - Patient must be actively receiving standard of care anti-PD-1 therapy, currently be 52 weeks (+/- 2 weeks) from start of anti-PD-1 therapy, and have not experienced a toxicity that prevents them from continuing on therapy. Permitted systemic anti-PD-1 therapy regimens include: - Nivolumab 240 mg IV every (Q)2weeks or 480 mg IV Q4weeks - Pembrolizumab 200 mg IV Q3weeks or 400 mg IV Q6weeks - Nivolumab 1 mg/kg plus ipilimumab 3 mg/kg IV Q3weeks induction x 4 doses, followed by nivolumab 240 mg IV Q2weeks or 480 mg IV Q4weeks maintenance - Nivolumab 3 mg/kg plus Ipilimumab 1 mg/kg IV Q3weeks induction x 4 doses, followed by nivolumab 240 mg IV Q2weeks or 480 mg IV Q4weeks maintenance - Pembrolizumab 2 mg/kg (or 200 mg flat dose) plus Ipilimumab 1 mg/kg IV Q3weeks induction x 4 doses, followed by pembrolizumab 200 mg IV Q3weeks or 400 mg IV Q6weeks maintenance - Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Patients with detectable viral loads are excluded as it is unclear if these patients have a low risk of melanoma progression off anti-PD-1 treatment - For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated - Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load - Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial - Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better - Patient must have experienced complete response, partial response, or stable disease on restaging CT scans by imRECIST that is maintained on restaging scans obtained at week 52 (+/- 2 weeks) from start of initial anti-PD-1 therapy - Patient must have completed an FDG-PET/CT scan at week 52 (+/- 2 weeks) from start of initial anti-PD-1 therapy - Patients with PET/CT positive for hypermetabolic lesions: If a core needle, punch or excisional biopsy and pathological review of a representative lesion was not performed prior to pre-registration (Step 0) must either: - Be amenable to undergo a biopsy. Patient must not be on anticoagulation therapy or, if on anti-coagulation therapy, patient must be able to hold treatment for a biopsy procedure (core needle, punch or excisional biopsy). Anti-coagulation therapy is defined as low molecular weight heparin, warfarin, factor Xa inhibitor, or direct thrombin inhibitor - Have documentation of inability to perform the biopsy due to feasibility or safety concerns - Leukocytes >= 3,000/mcL (obtained =< 4 weeks prior to protocol registration) - Absolute neutrophil count >= 1,500/mcL (obtained =< 4 weeks prior to protocol registration) - Platelets >= 100,000/mcL (obtained =< 4 weeks prior to protocol registration) - Total bilirubin =< institutional upper limit of normal (ULN) (patients with history of Gilbert's syndrome are permitted to have a total bilirubin > 1.5 x institutional ULN) (obtained =< 4 weeks prior to protocol registration) - Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained =< 4 weeks prior to protocol registration) - Creatinine =< 1.5 x institutional ULN (obtained =< 4 weeks prior to protocol registration) - STEP 1 REGISTRATION INCLUSION CRITERIA - Patient met all eligibility criteria outlined above - Patient must register to Step 1 within 4 weeks of registration to Step 0 - Patients must meet one of the following criteria: - Patient had no positive hypermetabolic lesions on the week 52 FDG-PET/CT. - Patients with positive hypermetabolic lesion(s) on the week 52 FDG-PET/CT (positive hypermetabolic = standard uptake volume [SUV] > pooled mediastinal blood), one of the following must have occurred: - A representative lesion was biopsied (core needle, punch or excisional biopsy) within 14 days of registration to Step 0 and subsequent pathology review performed to determine the presence or absence of viable tumor - Documentation is present that the patient is not able to undergo biopsy of a hypermetabolic lesion due to feasibility or safety concerns, i.e., the lesion location that is not amenable to biopsy

Exclusion Criteria

  • STEP 0 PRE-REGISTRATION EXCLUSION CRITERIA - Patient must not be receiving concurrent anti-tumor therapies in addition to the standard of care anti-PD-1 regimens. Patients who are receiving bisphosphonates and RANKL inhibitors for management of bone metastases are eligible - Patient must not have brain metastases - Women must not be pregnant or breast-feeding due to potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the anti-PD-1 regimens being used. All females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) - Women of childbearing potential and sexually active males must not conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of study registration and continuing until at least 5 months after the last dose of anti-PD-1 treatment for female patients and for at least 7 months after the last dose of anti-PD-1 treatment for male patients who are sexually active with a women of childbearing potential (WOCBP)

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A (active surveillance)
Patients with a negative FDG-PET/CT scan or a positive FDG-PET/CT scan but with a negative biopsy for viable tumor discontinue the anti-PD-1 therapy and undergo active surveillance.
  • Other: Patient Observation
    Undergo active surveillance
    Other names:
    • Active Surveillance
    • deferred therapy
    • expectant management
    • Observation
    • Watchful Waiting
Active Comparator
Arm B (nivolumab, pembrolizumab, ipilimumab)
Patients with a positive FDG-PET/CT scan and positive biopsy for viable tumor or a positive FDG-PET/CT scan and biopsy not performed continue their standard of care anti-PD-1 therapy for 12 months in the absence of disease progression or unacceptable toxicity.
  • Biological: Nivolumab
    Given IV
    Other names:
    • BMS-936558
    • MDX-1106
    • NIVO
    • ONO-4538
    • Opdivo
  • Biological: Pembrolizumab
    Given IV
    Other names:
    • Keytruda
    • Lambrolizumab
    • MK-3475
    • SCH 900475
Other
Standard of Care (nivolumab, pembrolizumab, ipilimumab)
Patients continue their standard of care anti-PD-1 therapy. Treatment may consist of the following regimens: 1) nivolumab IV over 30 minutes Q2W or Q4W; 2) pembrolizumab IV over 30 minutes Q3W or Q6W; 3) nivolumab IV over 30 minutes and ipilimumab IV Q3W for 4 doses followed by nivolumab IV over 30 minutes Q2W or Q4W; or 4) pembrolizumab IV over 30 minutes and ipilimumab IV Q3W for 4 doses followed by pembrolizumab IV over 30 minutes Q3W or Q6W. Treatment continues until 52 weeks from start of standard of care anti-PD-1 therapy 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
  • Biological: Nivolumab
    Given IV
    Other names:
    • BMS-936558
    • MDX-1106
    • NIVO
    • ONO-4538
    • Opdivo
  • Biological: Pembrolizumab
    Given IV
    Other names:
    • Keytruda
    • Lambrolizumab
    • MK-3475
    • SCH 900475

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Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois 62269
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Pekin
Pekin, Illinois 61554
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peoria
Peoria, Illinois 61615
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Methodist Medical Center of Illinois
Peoria, Illinois 61636
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peru
Peru, Illinois 61354
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Valley Radiation Oncology
Peru, Illinois 61354
Contact:
Site Public Contact
815-664-4141

Edward Hospital/Cancer Center?Plainfield
Plainfield, Illinois 60585
Contact:
Site Public Contact
630-646-6075
Cancerresearch@edward.org

Illinois CancerCare-Princeton
Princeton, Illinois 61356
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Southern Illinois University School of Medicine
Springfield, Illinois 62702
Contact:
Site Public Contact
217-545-7929

Springfield Clinic
Springfield, Illinois 62702
Contact:
Site Public Contact
800-444-7541

Memorial Medical Center
Springfield, Illinois 62781
Contact:
Site Public Contact
217-528-7541
pallante.beth@mhsil.com

Illinois CancerCare - Washington
Washington, Illinois 61571
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Mission Cancer and Blood - Ankeny
Ankeny, Iowa 50023
Contact:
Site Public Contact
515-282-2921

Saint Anthony Regional Hospital
Carroll, Iowa 51401
Contact:
Site Public Contact
515-689-7658
sbenson@iora.org

Iowa Methodist Medical Center
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-6727

Mission Cancer and Blood - Des Moines
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-3305

Broadlawns Medical Center
Des Moines, Iowa 50314
Contact:
Site Public Contact
515-282-2200

Iowa Lutheran Hospital
Des Moines, Iowa 50316
Contact:
Site Public Contact
515-241-8704

Trinity Regional Medical Center
Fort Dodge, Iowa 50501
Contact:
Site Public Contact
515-574-8302

Methodist West Hospital
West Des Moines, Iowa 50266-7700
Contact:
Site Public Contact
515-343-1000

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

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

Flaget Memorial Hospital
Bardstown, Kentucky 40004
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Commonwealth Cancer Center-Corbin
Corbin, Kentucky 40701
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph Hospital
Lexington, Kentucky 40504
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky 40504
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph Hospital East
Lexington, Kentucky 40509
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph London
London, Kentucky 40741
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph Mount Sterling
Mount Sterling, Kentucky 40353
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Mercy Health - Paducah Medical Oncology and Hematology
Paducah, Kentucky 42003
Contact:
Site Public Contact
270-538-5632
BJWarner@mercy.com

MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland 21237
Contact:
Site Public Contact
443-777-7364

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Site Public Contact
617-638-8265

Hickman Cancer Center
Adrian, Michigan 49221
Contact:
Site Public Contact
517-265-0116

Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan 48106
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Bronson Battle Creek
Battle Creek, Michigan 49017
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health Medical Center - Brighton
Brighton, Michigan 48114
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health Medical Center - Canton
Canton, Michigan 48188
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Caro Cancer Center
Caro, Michigan 48723
Contact:
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

Chelsea Hospital
Chelsea, Michigan 48118
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Hematology Oncology Consultants-Clarkston
Clarkston, Michigan 48346
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Newland Medical Associates-Clarkston
Clarkston, Michigan 48346
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Ascension Saint John Hospital
Detroit, Michigan 48236
Contact:
Site Public Contact
313-343-3166
karen.forman@ascension.org

Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Genesee Hematology Oncology PC
Flint, Michigan 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Genesys Hurley Cancer Institute
Flint, Michigan 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Hurley Medical Center
Flint, Michigan 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan 49503
Contact:
Site Public Contact
616-267-1925
crcwm-regulatory@crcwm.org

Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Bronson Methodist Hospital
Kalamazoo, Michigan 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

West Michigan Cancer Center
Kalamazoo, Michigan 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Ascension Borgess Cancer Center
Kalamazoo, Michigan 49009
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Borgess Medical Center
Kalamazoo, Michigan 49048
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

University of Michigan Health - Sparrow Lansing
Lansing, Michigan 48912
Contact:
Site Public Contact
517-364-3712
harsha.trivedi@umhsparrow.org

Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan 48453
Contact:
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan 48162
Contact:
Site Public Contact
800-444-3561

Trinity Health Muskegon Hospital
Muskegon, Michigan 49444
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan 49120
Contact:
Site Public Contact
616-391-1230

Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan 49444
Contact:
Site Public Contact
616-391-1230
connie.szczepanek@crcwm.org

Hope Cancer Center
Pontiac, Michigan 48341
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Michigan Healthcare Professionals Pontiac
Pontiac, Michigan 48341
Contact:
Site Public Contact
248-858-6215
Emily.Crofts@trinity-health.org

Newland Medical Associates-Pontiac
Pontiac, Michigan 48341
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan 48341
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Corewell Health Reed City Hospital
Reed City, Michigan 49677
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Ascension Saint Mary's Hospital
Saginaw, Michigan 48601
Contact:
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan 48604
Contact:
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan 49085
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Ascension Saint Joseph Hospital
Tawas City, Michigan 48764
Contact:
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

Munson Medical Center
Traverse City, Michigan 49684
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Saint John Macomb-Oakland Hospital
Warren, Michigan 48093
Contact:
Site Public Contact
313-343-3166
karen.forman@ascension.org

Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan 48661
Contact:
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

University of Michigan Health - West
Wyoming, Michigan 49519
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Huron Gastroenterology PC
Ypsilanti, Michigan 48106
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Riverwood Healthcare Center
Aitkin, Minnesota 56431
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health - Baxter Clinic
Baxter, Minnesota 56425
Contact:
Site Public Contact
218-828-2880

Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
Contact:
Site Public Contact
218-333-5000
OncologyClinicalTrialsFargo@sanfordhealth.org

Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota 56401
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health - Deer River Clinic
Deer River, Minnesota 56636
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota 56501
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health Cancer Center
Duluth, Minnesota 55805
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health Saint Mary's Medical Center
Duluth, Minnesota 55805
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Miller-Dwan Hospital
Duluth, Minnesota 55805
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health - Ely Clinic
Ely, Minnesota 55731
Contact:
Site Public Contact
218-365-7900

Essentia Health - Fosston
Fosston, Minnesota 56542
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health Hibbing Clinic
Hibbing, Minnesota 55746
Contact:
Site Public Contact
218-786-3308

Essentia Health - International Falls Clinic
International Falls, Minnesota 56649
Contact:
Site Public Contact
218-283-9431

Essentia Health - Moose Lake Clinic
Moose Lake, Minnesota 55767
Contact:
Site Public Contact
218-485-4481

Essentia Health - Park Rapids
Park Rapids, Minnesota 56470
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota 56303
Contact:
Site Public Contact
877-229-4907
coborncancercenter@centracare.com

Essentia Health Sandstone
Sandstone, Minnesota 55072
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota 56701
Contact:
Site Public Contact
605-312-3320

Essentia Health Virginia Clinic
Virginia, Minnesota 55792
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Sanford Cancer Center Worthington
Worthington, Minnesota 56187
Contact:
Site Public Contact
605-312-3320

Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri 63011
Contact:
Site Public Contact
314-251-7058

Central Care Cancer Center - Bolivar
Bolivar, Missouri 65613
Contact:
Site Public Contact
913-948-5588
aroland@kccop.org

Cox Cancer Center Branson
Branson, Missouri 65616
Contact:
Site Public Contact
417-269-4520

Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Contact:
Site Public Contact
573-334-2230
sfmc@sfmc.net

Southeast Cancer Center
Cape Girardeau, Missouri 63703
Contact:
Site Public Contact
573-651-5550

Parkland Health Center - Farmington
Farmington, Missouri 63640
Contact:
Site Public Contact
314-996-5569

Freeman Health System
Joplin, Missouri 64804
Contact:
Site Public Contact
417-347-4030
LJCrockett@freemanhealth.com

Mercy Hospital Joplin
Joplin, Missouri 64804
Contact:
Site Public Contact
417-556-3074
esmeralda.carrillo@mercy.net

Lake Regional Hospital
Osage Beach, Missouri 65065
Contact:
Site Public Contact
573-302-2768
clinicaltrials@lakeregional.com

Delbert Day Cancer Institute at PCRMC
Rolla, Missouri 65401
Contact:
Site Public Contact
573-458-7504
research@phelpshealth.org

Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri 65401
Contact:
Site Public Contact
573-458-6379

Heartland Regional Medical Center
Saint Joseph, Missouri 64506
Contact:
Site Public Contact
816-271-7937
linda.schumacher@mymlc.com

Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri 63109
Contact:
Site Public Contact
314-353-1870

Mercy Hospital South
Saint Louis, Missouri 63128
Contact:
Site Public Contact
314-525-6042
Danielle.Werle@mercy.net

Missouri Baptist Medical Center
Saint Louis, Missouri 63131
Contact:
Site Public Contact
314-996-5569

Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
Contact:
Site Public Contact
314-251-7066

Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
Contact:
Site Public Contact
314-996-5569

Mercy Hospital Springfield
Springfield, Missouri 65804
Contact:
Site Public Contact
417-269-4520

CoxHealth South Hospital
Springfield, Missouri 65807
Contact:
Site Public Contact
417-269-4520

Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
Contact:
Site Public Contact
314-996-5569

BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri 63127
Contact:
Site Public Contact
314-996-5569

Mercy Hospital Washington
Washington, Missouri 63090
Contact:
Site Public Contact
636-390-1600

Community Hospital of Anaconda
Anaconda, Montana 59711
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Billings Clinic Cancer Center
Billings, Montana 59101
Contact:
Site Public Contact
800-996-2663
research@billingsclinic.org

Bozeman Health Deaconess Hospital
Bozeman, Montana 59715
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Benefis Sletten Cancer Institute
Great Falls, Montana 59405
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Great Falls Clinic
Great Falls, Montana 59405
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Kalispell Regional Medical Center
Kalispell, Montana 59901
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Community Medical Center
Missoula, Montana 59804
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

CHI Health Good Samaritan
Kearney, Nebraska 68847
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Immanuel Medical Center
Omaha, Nebraska 68122
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska 68124
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Lakeside Hospital
Omaha, Nebraska 68130
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Creighton University Medical Center
Omaha, Nebraska 68131
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Hackensack University Medical Center
Hackensack, New Jersey 07601
Contact:
Site Public Contact
551-996-2897

Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
Contact:
Site Public Contact
212-639-7592

Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
Contact:
Site Public Contact
212-639-7592

Jersey Shore Medical Center
Neptune, New Jersey 07753
Contact:
Site Public Contact
732-776-4240

Riverview Medical Center/Booker Cancer Center
Red Bank, New Jersey 07701
Contact:
Site Public Contact
732-530-2382

University of New Mexico Cancer Center
Albuquerque, New Mexico 87106
Contact:
Site Public Contact
505-925-0348
HSC-ClinicalTrialInfo@salud.unm.edu

Glens Falls Hospital
Glens Falls, New York 12801
Contact:
Site Public Contact
518-926-6700

Memorial Sloan Kettering Westchester
Harrison, New York 10604
Contact:
Site Public Contact
212-639-7592

Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York 10016
Contact:
Site Public Contact
CancerTrials@nyulangone.org

Duke Cancer Institute Cary
Cary, North Carolina 27518
Contact:
Site Public Contact
919-781-7070

UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
Contact:
Site Public Contact
877-668-0683
cancerclinicaltrials@med.unc.edu

Duke University Medical Center
Durham, North Carolina 27710
Contact:
Site Public Contact
888-275-3853

East Carolina University
Greenville, North Carolina 27834
Contact:
Site Public Contact
252-744-1015
eubankss@ecu.edu

Duke Women's Cancer Care Raleigh
Raleigh, North Carolina 27607
Contact:
Site Public Contact
919-785-4878

Duke Raleigh Hospital
Raleigh, North Carolina 27609
Contact:
Site Public Contact
919-862-5400

Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
Contact:
Site Public Contact
701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org

Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota 58103
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Sanford South University Medical Center
Fargo, North Dakota 58103
Contact:
Site Public Contact
701-234-6161

Southpointe-Sanford Medical Center Fargo
Fargo, North Dakota 58103
Contact:
Site Public Contact
605-312-3320

Sanford Medical Center Fargo
Fargo, North Dakota 58104
Contact:
Site Public Contact
800-437-4010

Sanford Broadway Medical Center
Fargo, North Dakota 58122
Contact:
Site Public Contact
701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
Contact:
Site Public Contact
701-234-6161
OncologyClinicalTrialsFargo@sanfordhealth.org

Essentia Health - Jamestown Clinic
Jamestown, North Dakota 58401
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio 44011
Contact:
Site Public Contact
800-641-2422

UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio 44122
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Strecker Cancer Center-Belpre
Belpre, Ohio 45714
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Miami Valley Hospital South
Centerville, Ohio 45459
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Adena Regional Medical Center
Chillicothe, Ohio 45601
Contact:
Site Public Contact
877-779-7585
Jeffh@columbusccop.org

University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio 45219
Contact:
Site Public Contact
513-584-7698
cancer@uchealth.com

Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio 45220
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Bethesda North Hospital
Cincinnati, Ohio 45242
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

TriHealth Cancer Institute-Westside
Cincinnati, Ohio 45247
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

TriHealth Cancer Institute-Anderson
Cincinnati, Ohio 45255
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Case Western Reserve University
Cleveland, Ohio 44106
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

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

Mount Carmel East Hospital
Columbus, Ohio 43213
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

The Mark H Zangmeister Center
Columbus, Ohio 43219
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Mount Carmel Health Center West
Columbus, Ohio 43222
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Miami Valley Hospital
Dayton, Ohio 45409
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Premier Blood and Cancer Center
Dayton, Ohio 45409
Contact:
Site Public Contact
937-276-8320

Miami Valley Hospital North
Dayton, Ohio 45415
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Central Ohio Breast and Endocrine Surgery
Gahanna, Ohio 43230
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Miami Valley Cancer Care and Infusion
Greenville, Ohio 45331
Contact:
Site Public Contact
937-569-7515

Mount Carmel Grove City Hospital
Grove City, Ohio 43123
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Zangmeister Center Grove City
Grove City, Ohio 43123
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Fairfield Medical Center
Lancaster, Ohio 43130
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Saint Rita's Medical Center
Lima, Ohio 45801
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Marietta Memorial Hospital
Marietta, Ohio 45750
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Memorial Hospital
Marysville, Ohio 43040
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio 43537
Contact:
Site Public Contact
pshoup@toledoclinic.com

Knox Community Hospital
Mount Vernon, Ohio 43050
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Mount Carmel New Albany Surgical Hospital
New Albany, Ohio 43054
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Licking Memorial Hospital
Newark, Ohio 43055
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Newark Radiation Oncology
Newark, Ohio 43055
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Mercy Health Perrysburg Cancer Center
Perrysburg, Ohio 43551
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Southern Ohio Medical Center
Portsmouth, Ohio 45662
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

UH Seidman Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio 44870
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Springfield Regional Cancer Center
Springfield, Ohio 45504
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Springfield Regional Medical Center
Springfield, Ohio 45504
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Mercy Health - Saint Vincent Hospital
Toledo, Ohio 43608
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Mercy Health - Saint Anne Hospital
Toledo, Ohio 43623
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Mercy Health Sylvania Radiation Oncology Center
Toledo, Ohio 43623
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio 43623
Contact:
Site Public Contact
800-444-3561

Upper Valley Medical Center
Troy, Ohio 45373
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

University of Cincinnati Cancer Center-West Chester
West Chester, Ohio 45069
Contact:
Site Public Contact
513-584-7698
cancer@uchealth.com

Saint Ann's Hospital
Westerville, Ohio 43081
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center
Wilmington, Ohio 45177
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Genesis Healthcare System Cancer Care Center
Zanesville, Ohio 43701
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma 73120
Contact:
Site Public Contact
405-752-3402

Saint Alphonsus Cancer Care Center-Baker City
Baker City, Oregon 97814
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon 97914
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania 18103
Contact:
Site Public Contact
610-402-9543
Morgan_M.Horton@lvhn.org

Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania 18017
Contact:
Site Public Contact
610-402-9543
Morgan_M.Horton@lvhn.org

Geisinger Medical Center
Danville, Pennsylvania 17822
Contact:
Site Public Contact
570-271-5251
HemonCCTrials@geisinger.edu

Pocono Medical Center
East Stroudsburg, Pennsylvania 18301
Contact:
Site Public Contact
610-402-9543
Morgan_M.Horton@lvhn.org

Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania 18201
Contact:
Site Public Contact
570-459-2901
HemonCCTrials@geisinger.edu

Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania 18201
Contact:
Site Public Contact
610-402-9543
Morgan_M.Horton@lvhn.org

Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania 17837
Contact:
Site Public Contact
570-374-8555
HemonCCTrials@geisinger.edu

Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania 17901
Contact:
Site Public Contact
800-275-6401
HemonCCTrials@geisinger.edu

Community Medical Center
Scranton, Pennsylvania 18510
Contact:
Site Public Contact
570-703-4768
HemonCCTrials@geisinger.edu

Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
Contact:
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570-271-5251
HemonCCTrials@geisinger.edu

Asplundh Cancer Pavilion
Willow Grove, Pennsylvania 19090
Contact:
Site Public Contact
215-600-9151
ONCTrialNow@jefferson.edu

Gibbs Cancer Center-Gaffney
Gaffney, South Carolina 29341
Contact:
Site Public Contact
864-560-6104
kmertz-rivera@gibbscc.org

Gibbs Cancer Center-Pelham
Greer, South Carolina 29651
Contact:
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864-560-6104
kmertz-rivera@gibbscc.org

North Grove Medical Park
Spartanburg, South Carolina 29303
Contact:
Site Public Contact
864-560-6812

Spartanburg Medical Center
Spartanburg, South Carolina 29303
Contact:
Site Public Contact
864-560-6104
kmertz-rivera@gibbscc.org

Spartanburg Medical Center - Mary Black Campus
Spartanburg, South Carolina 29307
Contact:
Site Public Contact
864-560-6812

MGC Hematology Oncology-Union
Union, South Carolina 29379
Contact:
Site Public Contact
864-560-6104
kmertz-rivera@gibbscc.org

Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
Contact:
Site Public Contact
605-312-3320
OncologyClinicTrialsSF@sanfordhealth.org

Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
Contact:
Site Public Contact
605-312-3320
OncologyClinicalTrialsSF@SanfordHealth.org

Central Vermont Medical Center/National Life Cancer Treatment
Berlin, Vermont 05602
Contact:
Site Public Contact
802-225-5400

University of Vermont Medical Center
Burlington, Vermont 05401
Contact:
Site Public Contact
802-656-4101
rpo@uvm.edu

University of Vermont and State Agricultural College
Burlington, Vermont 05405
Contact:
Site Public Contact
802-656-8990
rpo@uvm.edu

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

Jefferson Healthcare
Port Townsend, Washington 98368
Contact:
Site Public Contact
360-344-3091

Saint Michael Cancer Center
Silverdale, Washington 98383
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Duluth Clinic Ashland
Ashland, Wisconsin 54806
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Northwest Wisconsin Cancer Center
Ashland, Wisconsin 54806
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin 54729
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Essentia Health-Hayward Clinic
Hayward, Wisconsin 54843
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Marshfield Medical Center - Ladysmith
Ladysmith, Wisconsin 54848
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Contact:
Site Public Contact
414-805-3666

Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin 54548
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

ProHealth D N Greenwald Center
Mukwonago, Wisconsin 53149
Contact:
Site Public Contact
research.institute@phci.org

ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066
Contact:
Site Public Contact
262-928-7878

Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Essentia Health-Spooner Clinic
Spooner, Wisconsin 54801
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin 54880
Contact:
Site Public Contact
701-364-6272

ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin 53188
Contact:
Site Public Contact
262-928-7632

UW Cancer Center at ProHealth Care
Waukesha, Wisconsin 53188
Contact:
Site Public Contact
262-928-5539
Chanda.miller@phci.org

Marshfield Clinic-Wausau Center
Wausau, Wisconsin 54401
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Marshfield Medical Center - Weston
Weston, Wisconsin 54476
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin 54494
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Billings Clinic-Cody
Cody, Wyoming 82414
Contact:
Site Public Contact
800-996-2663
research@billingsclinic.org

Welch Cancer Center
Sheridan, Wyoming 82801
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

More Details

NCT ID
NCT04462406
Status
Recruiting
Sponsor
ECOG-ACRIN Cancer Research Group

Detailed Description

PRIMARY OBJECTIVE: I. To determine the 12 month event free survival (EFS) rate following discontinuation of anti-PD-1 therapy in patients with disease control and negative fludeoxyglucose F-18 (FDG)- positron emission tomography (PET)/computed tomography (CT) scan or biopsy for residual disease after 12 months of anti-PD-1 therapy (Arm A). SECONDARY OBJECTIVES: I. To determine rates of pathologic response in patients with tumor biopsies where positive hypermetabolic activity was present on FDG-PET/CT scan after 12 months of anti-PD-1 therapy (Arm B). II. To determine the overall 24 month EFS. III. To determine overall survival from start of anti-PD-1 therapy. IV. To determine percentage for patients who remain on treatment beyond 12 months because of positive FDG-PET/CT scan and positive biopsy for residual disease (or unable to obtain a biopsy). V. To determine incidence rates of treatment-related adverse events beyond 12 months from start of treatment in patients who discontinue anti-PD-1 therapy at 12 months and in patients who continue anti-PD-1 therapy beyond 12 months (Arm A versus [vs.] Arm B). EXPLORATORY OBJECTIVES: I. To assess agreement in determining FDG-PET/CT positivity between the local site read and central review. II. To determine if metabolic response on serial FDG-PET/CT from pre-therapy to 12 months of anti-PD-1 therapy, as determined centrally by various criteria, is associated with EFS. III. To determine if metabolic response on serial FDG-PET/CT from 12 to 24 months after start of anti-PD-1 therapy, as determined centrally by various criteria, is associated with EFS. BIOMARKER OBJECTIVE: I. To bank tumor samples and peripheral blood for future biomarker studies. OUTLINE: Patients continue their standard of care anti-PD-1 therapy and are then assigned to 1 of 2 arms. STANDARD OF CARE: Treatment may consist of the following regimens: 1) nivolumab intravenously (IV) over 30 minutes every 2 weeks (Q2W) or every 4 weeks (Q4W); 2) pembrolizumab IV over 30 minutes every 3 weeks (Q3W) or every 6 weeks (Q6W); 3) nivolumab IV over 30 minutes and ipilimumab IV Q3W for 4 doses followed by nivolumab IV over 30 minutes Q2W or Q4W; or 4) pembrolizumab IV over 30 minutes and ipilimumab IV Q3W for 4 doses followed by pembrolizumab IV over 30 minutes Q3W or Q6W. Treatment continues until 52 weeks from start of standard of care anti-PD-1 therapy in the absence of disease progression or unacceptable toxicity. ARM A: Patients with a negative FDG-PET/CT scan or a positive FDG-PET/CT scan but with a negative biopsy for viable tumor discontinue the anti-PD-1 therapy and undergo active surveillance. ARM B: Patients with a positive FDG-PET/CT scan and positive biopsy for viable tumor or a positive FDG-PET/CT scan and biopsy not performed continue their standard of care anti-PD-1 therapy for 12 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up through week 97 and then every 3 months for up to 5 years.