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 Sex
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

Recruiting Locations

Thomas Hospital
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Mobile Infirmary Medical Center
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University of Arizona Cancer Center-North Campus
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Mercy Hospital Fort Smith
Fort Smith 4111410, Arkansas 4099753 72903
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CARTI Cancer Center
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University of Arkansas for Medical Sciences
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Antioch 5324200, California 5332921 94531
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Rohnert Park Cancer Center
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The Permanente Medical Group-Roseville Radiation Oncology
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Boulder Community Foothills Hospital
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Centennial 5416541, Colorado 5417618 80112
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Penrose-Saint Francis Healthcare
Colorado Springs 5417598, Colorado 5417618 80907
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Colorado Springs 5417598, Colorado 5417618 80907
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Saint Francis Cancer Center
Colorado Springs 5417598, Colorado 5417618 80923
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Kaiser Permanente-Franklin
Denver 5419384, Colorado 5417618 80205
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The Women's Imaging Center
Denver 5419384, Colorado 5417618 80209
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Presbyterian - Saint Lukes Medical Center - Health One
Denver 5419384, Colorado 5417618 80218
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Rocky Mountain Cancer Centers-Midtown
Denver 5419384, Colorado 5417618 80218
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Denver 5419384, Colorado 5417618 80220
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Mercy Medical Center
Durango 5420241, Colorado 5417618 81301
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Rocky Mountain Cancer Centers - Swedish
Englewood 5421250, Colorado 5417618 80113
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The Melanoma and Skin Cancer Institute
Englewood 5421250, Colorado 5417618 80113
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Kaiser Permanente-Rock Creek
Lafayette 5427771, Colorado 5417618 80026
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Rocky Mountain Cancer Centers-Lakewood
Lakewood 5427946, Colorado 5417618 80228
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Saint Anthony Hospital
Lakewood 5427946, Colorado 5417618 80228
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Rocky Mountain Cancer Centers-Littleton
Littleton 5429032, Colorado 5417618 80120
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Kaiser Permanente-Lone Tree
Lone Tree 5429208, Colorado 5417618 80124
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Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree 5429208, Colorado 5417618 80124
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Longmont United Hospital
Longmont 5579276, Colorado 5417618 80501
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Rocky Mountain Cancer Centers-Longmont
Longmont 5579276, Colorado 5417618 80501
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Saint Mary Corwin Medical Center
Pueblo 5435464, Colorado 5417618 81004
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Rocky Mountain Cancer Centers-Thornton
Thornton 5441492, Colorado 5417618 80260
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MedStar Georgetown University Hospital
Washington D.C. 4140963, District of Columbia 4138106 20007
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202-444-2223

MedStar Washington Hospital Center
Washington D.C. 4140963, District of Columbia 4138106 20010
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202-877-8839

UM Sylvester Comprehensive Cancer Center at Aventura
Aventura 4146429, Florida 4155751 33180
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954-461-2180

UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables 4151871, Florida 4155751 33146
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UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach 4153071, Florida 4155751 33442
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Holy Cross Hospital
Fort Lauderdale 4155966, Florida 4155751 33308
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University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami 4164138, Florida 4155751 33136
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UM Sylvester Comprehensive Cancer Center at Kendall
Miami 4164138, Florida 4155751 33176
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UM Sylvester Comprehensive Cancer Center at Plantation
Plantation 4168782, Florida 4155751 33324
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Emory University Hospital/Winship Cancer Institute
Atlanta 4180439, Georgia 4197000 30322
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404-778-1868

Northside Hospital
Atlanta 4180439, Georgia 4197000 30342
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Northside Hospital - Duluth
Duluth 4192289, Georgia 4197000 30096
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Northside Hospital - Gwinnett
Lawrenceville 4205196, Georgia 4197000 30046
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Kaiser Permanente Moanalua Medical Center
Honolulu 5856195, Hawaii 5855797 96819
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808-432-5195
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Saint Alphonsus Cancer Care Center-Boise
Boise 5586437, Idaho 5596512 83706
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Saint Alphonsus Cancer Care Center-Caldwell
Caldwell 5587698, Idaho 5596512 83605
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Kootenai Health - Coeur d'Alene
Coeur d'Alene 5589173, Idaho 5596512 83814
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406-969-6060
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Walter Knox Memorial Hospital
Emmett 5592562, Idaho 5596512 83617
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Idaho Urologic Institute-Meridian
Meridian 5600685, Idaho 5596512 83642
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Saint Alphonsus Cancer Care Center-Nampa
Nampa 5601933, Idaho 5596512 83687
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Kootenai Clinic Cancer Services - Post Falls
Post Falls 5604353, Idaho 5596512 83854
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Kootenai Clinic Cancer Services - Sandpoint
Sandpoint 5606401, Idaho 5596512 83864
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Saint Anthony's Health
Alton 4232679, Illinois 4896861 62002
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618-463-5623

Illinois CancerCare-Bloomington
Bloomington 4885164, Illinois 4896861 61704
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309-243-3605
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Illinois CancerCare-Canton
Canton 4831990, Illinois 4896861 61520
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309-243-3605
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Memorial Hospital of Carbondale
Carbondale 4235193, Illinois 4896861 62902
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SIH Cancer Institute
Carterville 4235311, Illinois 4896861 62918
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618-985-3333
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Illinois CancerCare-Carthage
Carthage 4886716, Illinois 4896861 62321
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Centralia Oncology Clinic
Centralia 4235587, Illinois 4896861 62801
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217-876-4762
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Saint Mary's Hospital
Centralia 4235587, Illinois 4896861 62801
Contact:
Site Public Contact
ecog.rss@jimmy.harvard.edu

Northwestern University
Chicago 4887398, Illinois 4896861 60611
Contact:
Site Public Contact
312-695-1301
cancer@northwestern.edu

University of Illinois
Chicago 4887398, Illinois 4896861 60612
Contact:
Site Public Contact
312-355-3046

Cancer Care Specialists of Illinois - Decatur
Decatur 4236895, Illinois 4896861 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Decatur 4236895, Illinois 4896861 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Illinois CancerCare-Dixon
Dixon 4889959, Illinois 4896861 61021
Contact:
Site Public Contact
815-285-7800

Crossroads Cancer Center
Effingham 4237727, Illinois 4896861 62401
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Elmhurst Memorial Hospital
Elmhurst 4891010, Illinois 4896861 60126
Contact:
Site Public Contact
630-758-5460
Jrohde@emhc.org

Illinois CancerCare-Eureka
Eureka 4891310, Illinois 4896861 61530
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Galesburg
Galesburg 4893392, Illinois 4896861 61401
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Western Illinois Cancer Treatment Center
Galesburg 4893392, Illinois 4896861 61401
Contact:
Site Public Contact
309-344-2831

Illinois CancerCare-Kewanee Clinic
Kewanee 4898433, Illinois 4896861 61443
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Macomb
Macomb 4900817, Illinois 4896861 61455
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Good Samaritan Regional Health Center
Mount Vernon 4245152, Illinois 4896861 62864
Contact:
Site Public Contact
618-242-4600

Edward Hospital/Cancer Center
Naperville 4903279, Illinois 4896861 60540
Contact:
Site Public Contact
630-646-6075

Cancer Care Center of O'Fallon
O'Fallon 4245926, Illinois 4896861 62269
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

HSHS Saint Elizabeth's Hospital
O'Fallon 4245926, Illinois 4896861 62269
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Illinois CancerCare-Ottawa Clinic
Ottawa 4905006, Illinois 4896861 61350
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Pekin
Pekin 4905599, Illinois 4896861 61554
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peoria
Peoria 4905687, Illinois 4896861 61615
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Methodist Medical Center of Illinois
Peoria 4905687, Illinois 4896861 61636
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peru
Peru 4905770, Illinois 4896861 61354
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Valley Radiation Oncology
Peru 4905770, Illinois 4896861 61354
Contact:
Site Public Contact
815-664-4141

Edward Hospital/Cancer Center?Plainfield
Plainfield 4906125, Illinois 4896861 60585
Contact:
Site Public Contact
630-646-6075
Cancerresearch@edward.org

Illinois CancerCare-Princeton
Princeton 4906818, Illinois 4896861 61356
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Southern Illinois University School of Medicine
Springfield 4250542, Illinois 4896861 62702
Contact:
Site Public Contact
217-545-7929

Springfield Clinic
Springfield 4250542, Illinois 4896861 62702
Contact:
Site Public Contact
800-444-7541

Memorial Medical Center
Springfield 4250542, Illinois 4896861 62781
Contact:
Site Public Contact
217-528-7541
pallante.beth@mhsil.com

Illinois CancerCare - Washington
Washington 4915545, Illinois 4896861 61571
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Mission Cancer and Blood - Ankeny
Ankeny 4846960, Iowa 4862182 50023
Contact:
Site Public Contact
515-282-2921

Saint Anthony Regional Hospital
Carroll 4850478, Iowa 4862182 51401
Contact:
Site Public Contact
515-689-7658
sbenson@iora.org

Iowa Methodist Medical Center
Des Moines 4853828, Iowa 4862182 50309
Contact:
Site Public Contact
515-241-6727

Mission Cancer and Blood - Des Moines
Des Moines 4853828, Iowa 4862182 50309
Contact:
Site Public Contact
515-241-3305

Broadlawns Medical Center
Des Moines 4853828, Iowa 4862182 50314
Contact:
Site Public Contact
515-282-2200

Iowa Lutheran Hospital
Des Moines 4853828, Iowa 4862182 50316
Contact:
Site Public Contact
515-241-8704

Trinity Regional Medical Center
Fort Dodge 4857486, Iowa 4862182 50501
Contact:
Site Public Contact
515-574-8302

Methodist West Hospital
West Des Moines 4881346, Iowa 4862182 50266-7700
Contact:
Site Public Contact
515-343-1000

Central Care Cancer Center - Garden City
Garden City 5445439, Kansas 4273857 67846
Contact:
Site Public Contact
913-948-5588
aroland@kccop.org

Central Care Cancer Center - Great Bend
Great Bend 4272340, Kansas 4273857 67530
Contact:
Site Public Contact
913-948-5588
aroland@kccop.org

Flaget Memorial Hospital
Bardstown 4283133, Kentucky 6254925 40004
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Commonwealth Cancer Center-Corbin
Corbin 4288656, Kentucky 6254925 40701
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph Hospital
Lexington 4297983, Kentucky 6254925 40504
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph Radiation Oncology Resource Center
Lexington 4297983, Kentucky 6254925 40504
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph Hospital East
Lexington 4297983, Kentucky 6254925 40509
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph London
London 4298960, Kentucky 6254925 40741
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Saint Joseph Mount Sterling
Mount Sterling 4301683, Kentucky 6254925 40353
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Mercy Health - Paducah Medical Oncology and Hematology
Paducah 4048662, Kentucky 6254925 42003
Contact:
Site Public Contact
270-538-5632
BJWarner@mercy.com

MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore 4347778, Maryland 4361885 21237
Contact:
Site Public Contact
443-777-7364

Boston Medical Center
Boston 4930956, Massachusetts 6254926 02118
Contact:
Site Public Contact
617-638-8265

Hickman Cancer Center
Adrian 4983811, Michigan 5001836 49221
Contact:
Site Public Contact
517-265-0116

Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor 4984247, Michigan 5001836 48106
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Bronson Battle Creek
Battle Creek 4985153, Michigan 5001836 49017
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton 4986994, Michigan 5001836 48114
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health Medical Center - Brighton
Brighton 4986994, Michigan 5001836 48114
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton 4987990, Michigan 5001836 48188
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health Medical Center - Canton
Canton 4987990, Michigan 5001836 48188
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Caro Cancer Center
Caro 4988059, Michigan 5001836 48723
Contact:
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

Chelsea Hospital
Chelsea 4988628, Michigan 5001836 48118
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea 4988628, Michigan 5001836 48118
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Hematology Oncology Consultants-Clarkston
Clarkston 4988997, Michigan 5001836 48346
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Newland Medical Associates-Clarkston
Clarkston 4988997, Michigan 5001836 48346
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Ascension Saint John Hospital
Detroit 4990729, Michigan 5001836 48236
Contact:
Site Public Contact
313-343-3166
karen.forman@ascension.org

Genesee Cancer and Blood Disease Treatment Center
Flint 4992982, Michigan 5001836 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Genesee Hematology Oncology PC
Flint 4992982, Michigan 5001836 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Genesys Hurley Cancer Institute
Flint 4992982, Michigan 5001836 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Hurley Medical Center
Flint 4992982, Michigan 5001836 48503
Contact:
Site Public Contact
810-762-8038
wstrong@ghci.org

Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids 4994358, Michigan 5001836 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids 4994358, Michigan 5001836 49503
Contact:
Site Public Contact
616-267-1925
crcwm-regulatory@crcwm.org

Trinity Health Grand Rapids Hospital
Grand Rapids 4994358, Michigan 5001836 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Bronson Methodist Hospital
Kalamazoo 4997787, Michigan 5001836 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

West Michigan Cancer Center
Kalamazoo 4997787, Michigan 5001836 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Ascension Borgess Cancer Center
Kalamazoo 4997787, Michigan 5001836 49009
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Borgess Medical Center
Kalamazoo 4997787, Michigan 5001836 49048
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

University of Michigan Health - Sparrow Lansing
Lansing 4998830, Michigan 5001836 48912
Contact:
Site Public Contact
517-364-3712
harsha.trivedi@umhsparrow.org

Trinity Health Saint Mary Mercy Livonia Hospital
Livonia 4999837, Michigan 5001836 48154
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Saint Mary's Oncology/Hematology Associates of Marlette
Marlette 5000938, Michigan 5001836 48453
Contact:
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

Toledo Clinic Cancer Centers-Monroe
Monroe 5002344, Michigan 5001836 48162
Contact:
Site Public Contact
800-444-3561

Trinity Health Muskegon Hospital
Muskegon 5003132, Michigan 5001836 49444
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health Lakeland Hospitals - Niles Hospital
Niles 5003514, Michigan 5001836 49120
Contact:
Site Public Contact
616-391-1230

Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores 5004005, Michigan 5001836 49444
Contact:
Site Public Contact
616-391-1230
connie.szczepanek@crcwm.org

Hope Cancer Center
Pontiac 5006166, Michigan 5001836 48341
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Michigan Healthcare Professionals Pontiac
Pontiac 5006166, Michigan 5001836 48341
Contact:
Site Public Contact
248-858-6215
Emily.Crofts@trinity-health.org

Newland Medical Associates-Pontiac
Pontiac 5006166, Michigan 5001836 48341
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac 5006166, Michigan 5001836 48341
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Corewell Health Reed City Hospital
Reed City 5006946, Michigan 5001836 49677
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Ascension Saint Mary's Hospital
Saginaw 5007989, Michigan 5001836 48601
Contact:
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

Oncology Hematology Associates of Saginaw Valley PC
Saginaw 5007989, Michigan 5001836 48604
Contact:
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph 5008327, Michigan 5001836 49085
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph 5008327, Michigan 5001836 49085
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Ascension Saint Joseph Hospital
Tawas City 5011900, Michigan 5001836 48764
Contact:
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

Munson Medical Center
Traverse City 5012495, Michigan 5001836 49684
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Saint John Macomb-Oakland Hospital
Warren 5014051, Michigan 5001836 48093
Contact:
Site Public Contact
313-343-3166
karen.forman@ascension.org

Saint Mary's Oncology/Hematology Associates of West Branch
West Branch 5014413, Michigan 5001836 48661
Contact:
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

University of Michigan Health - West
Wyoming 5015618, Michigan 5001836 49519
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Huron Gastroenterology PC
Ypsilanti 5015688, Michigan 5001836 48106
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti 5015688, Michigan 5001836 48197
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Riverwood Healthcare Center
Aitkin 5015978, Minnesota 5037779 56431
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health - Baxter Clinic
Baxter 5017396, Minnesota 5037779 56425
Contact:
Site Public Contact
218-828-2880

Sanford Joe Lueken Cancer Center
Bemidji 5017822, Minnesota 5037779 56601
Contact:
Site Public Contact
218-333-5000
OncologyClinicalTrialsFargo@sanfordhealth.org

Essentia Health Saint Joseph's Medical Center
Brainerd 5019116, Minnesota 5037779 56401
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health - Deer River Clinic
Deer River 5024099, Minnesota 5037779 56636
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes 5024237, Minnesota 5037779 56501
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health Cancer Center
Duluth 5024719, Minnesota 5037779 55805
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health Saint Mary's Medical Center
Duluth 5024719, Minnesota 5037779 55805
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Miller-Dwan Hospital
Duluth 5024719, Minnesota 5037779 55805
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health - Ely Clinic
Ely 5025627, Minnesota 5037779 55731
Contact:
Site Public Contact
218-365-7900

Essentia Health - Fosston
Fosston 5027191, Minnesota 5037779 56542
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health Hibbing Clinic
Hibbing 5030005, Minnesota 5037779 55746
Contact:
Site Public Contact
218-786-3308

Essentia Health - International Falls Clinic
International Falls 5031404, Minnesota 5037779 56649
Contact:
Site Public Contact
218-283-9431

Essentia Health - Moose Lake Clinic
Moose Lake 5038132, Minnesota 5037779 55767
Contact:
Site Public Contact
218-485-4481

Essentia Health - Park Rapids
Park Rapids 5040822, Minnesota 5037779 56470
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud 5044407, Minnesota 5037779 56303
Contact:
Site Public Contact
877-229-4907
coborncancercenter@centracare.com

Essentia Health Sandstone
Sandstone 5045908, Minnesota 5037779 55072
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Sanford Thief River Falls Medical Center
Thief River Falls 5049970, Minnesota 5037779 56701
Contact:
Site Public Contact
605-312-3320

Essentia Health Virginia Clinic
Virginia 5051468, Minnesota 5037779 55792
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Sanford Cancer Center Worthington
Worthington 5053460, Minnesota 5037779 56187
Contact:
Site Public Contact
605-312-3320

Saint Louis Cancer and Breast Institute-Ballwin
Ballwin 4375663, Missouri 4398678 63011
Contact:
Site Public Contact
314-251-7058

Central Care Cancer Center - Bolivar
Bolivar 4377835, Missouri 4398678 65613
Contact:
Site Public Contact
913-948-5588
aroland@kccop.org

Cox Cancer Center Branson
Branson 4378219, Missouri 4398678 65616
Contact:
Site Public Contact
417-269-4520

Saint Francis Medical Center
Cape Girardeau 4379966, Missouri 4398678 63703
Contact:
Site Public Contact
573-334-2230
sfmc@sfmc.net

Southeast Cancer Center
Cape Girardeau 4379966, Missouri 4398678 63703
Contact:
Site Public Contact
573-651-5550

Parkland Health Center - Farmington
Farmington 4386289, Missouri 4398678 63640
Contact:
Site Public Contact
314-996-5569

Freeman Health System
Joplin 4392768, Missouri 4398678 64804
Contact:
Site Public Contact
417-347-4030
LJCrockett@freemanhealth.com

Mercy Hospital Joplin
Joplin 4392768, Missouri 4398678 64804
Contact:
Site Public Contact
417-556-3074
esmeralda.carrillo@mercy.net

Lake Regional Hospital
Osage Beach 4402040, Missouri 4398678 65065
Contact:
Site Public Contact
573-302-2768
clinicaltrials@lakeregional.com

Delbert Day Cancer Institute at PCRMC
Rolla 4406282, Missouri 4398678 65401
Contact:
Site Public Contact
573-458-7504
research@phelpshealth.org

Mercy Clinic-Rolla-Cancer and Hematology
Rolla 4406282, Missouri 4398678 65401
Contact:
Site Public Contact
573-458-6379

Heartland Regional Medical Center
Saint Joseph 4407010, Missouri 4398678 64506
Contact:
Site Public Contact
816-271-7937
linda.schumacher@mymlc.com

Sainte Genevieve County Memorial Hospital
Sainte Genevieve 4407294, Missouri 4398678 63670
Contact:
Site Public Contact
314-996-5569

Mercy Hospital Springfield
Springfield 4409896, Missouri 4398678 65804
Contact:
Site Public Contact
417-269-4520

CoxHealth South Hospital
Springfield 4409896, Missouri 4398678 65807
Contact:
Site Public Contact
417-269-4520

Saint Louis Cancer and Breast Institute-South City
St Louis 4407066, Missouri 4398678 63109
Contact:
Site Public Contact
314-353-1870

Mercy Hospital South
St Louis 4407066, Missouri 4398678 63128
Contact:
Site Public Contact
314-525-6042
Danielle.Werle@mercy.net

Missouri Baptist Medical Center
St Louis 4407066, Missouri 4398678 63131
Contact:
Site Public Contact
314-996-5569

Mercy Hospital Saint Louis
St Louis 4407066, Missouri 4398678 63141
Contact:
Site Public Contact
314-251-7066

Missouri Baptist Sullivan Hospital
Sullivan 4410669, Missouri 4398678 63080
Contact:
Site Public Contact
314-996-5569

BJC Outpatient Center at Sunset Hills
Sunset Hills 4410836, Missouri 4398678 63127
Contact:
Site Public Contact
314-996-5569

Mercy Hospital Washington
Washington 4413621, Missouri 4398678 63090
Contact:
Site Public Contact
636-390-1600

Community Hospital of Anaconda
Anaconda 5637146, Montana 5667009 59711
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Billings Clinic Cancer Center
Billings 5640350, Montana 5667009 59101
Contact:
Site Public Contact
800-996-2663
research@billingsclinic.org

Bozeman Health Deaconess Hospital
Bozeman 5641727, Montana 5667009 59715
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Benefis Sletten Cancer Institute
Great Falls 5655240, Montana 5667009 59405
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Great Falls Clinic
Great Falls 5655240, Montana 5667009 59405
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Kalispell Regional Medical Center
Kalispell 5660340, Montana 5667009 59901
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Community Medical Center
Missoula 5666639, Montana 5667009 59804
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

CHI Health Good Samaritan
Kearney 5071348, Nebraska 5073708 68847
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Immanuel Medical Center
Omaha 5074472, Nebraska 5073708 68122
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Bergan Mercy Medical Center
Omaha 5074472, Nebraska 5073708 68124
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Lakeside Hospital
Omaha 5074472, Nebraska 5073708 68130
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Creighton University Medical Center
Omaha 5074472, Nebraska 5073708 68131
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Hackensack University Medical Center
Hackensack 5098706, New Jersey 5101760 07601
Contact:
Site Public Contact
551-996-2897

Memorial Sloan Kettering Monmouth
Middletown 5101170, New Jersey 5101760 07748
Contact:
Site Public Contact
212-639-7592

Memorial Sloan Kettering Bergen
Montvale 5101361, New Jersey 5101760 07645
Contact:
Site Public Contact
212-639-7592

Jersey Shore Medical Center
Neptune City 5101687, New Jersey 5101760 07753
Contact:
Site Public Contact
732-776-4240

Riverview Medical Center/Booker Cancer Center
Red Bank 5103159, New Jersey 5101760 07701
Contact:
Site Public Contact
732-530-2382

University of New Mexico Cancer Center
Albuquerque 5454711, New Mexico 5481136 87106
Contact:
Site Public Contact
505-925-0348
HSC-ClinicalTrialInfo@salud.unm.edu

Memorial Sloan Kettering Westchester
East White Plains 5116104, New York 5128638 10604
Contact:
Site Public Contact
212-639-7592

Glens Falls Hospital
Glens Falls 5118693, New York 5128638 12801
Contact:
Site Public Contact
518-926-6700

Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York 5128581, New York 5128638 10016
Contact:
Site Public Contact
CancerTrials@nyulangone.org

Duke Cancer Institute Cary
Cary 4459467, North Carolina 4482348 27518
Contact:
Site Public Contact
919-781-7070

UNC Lineberger Comprehensive Cancer Center
Chapel Hill 4460162, North Carolina 4482348 27599
Contact:
Site Public Contact
877-668-0683
cancerclinicaltrials@med.unc.edu

Duke University Medical Center
Durham 4464368, North Carolina 4482348 27710
Contact:
Site Public Contact
888-275-3853

East Carolina University
Greenville 4469160, North Carolina 4482348 27834
Contact:
Site Public Contact
252-744-1015
eubankss@ecu.edu

Duke Women's Cancer Care Raleigh
Raleigh 4487042, North Carolina 4482348 27607
Contact:
Site Public Contact
919-785-4878

Duke Raleigh Hospital
Raleigh 4487042, North Carolina 4482348 27609
Contact:
Site Public Contact
919-862-5400

Sanford Bismarck Medical Center
Bismarck 5688025, North Dakota 5690763 58501
Contact:
Site Public Contact
701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org

Essentia Health Cancer Center-South University Clinic
Fargo 5059163, North Dakota 5690763 58103
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Sanford South University Medical Center
Fargo 5059163, North Dakota 5690763 58103
Contact:
Site Public Contact
701-234-6161

Southpointe-Sanford Medical Center Fargo
Fargo 5059163, North Dakota 5690763 58103
Contact:
Site Public Contact
605-312-3320

Sanford Medical Center Fargo
Fargo 5059163, North Dakota 5690763 58104
Contact:
Site Public Contact
800-437-4010

Sanford Broadway Medical Center
Fargo 5059163, North Dakota 5690763 58122
Contact:
Site Public Contact
701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Roger Maris Cancer Center
Fargo 5059163, North Dakota 5690763 58122
Contact:
Site Public Contact
701-234-6161
OncologyClinicalTrialsFargo@sanfordhealth.org

Essentia Health - Jamestown Clinic
Jamestown 5059836, North Dakota 5690763 58401
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

UH Seidman Cancer Center at UH Avon Health Center
Avon 5146277, Ohio 5165418 44011
Contact:
Site Public Contact
800-641-2422

UHHS-Chagrin Highlands Medical Center
Beachwood 5146711, Ohio 5165418 44122
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Strecker Cancer Center-Belpre
Belpre 4506187, Ohio 5165418 45714
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Miami Valley Hospital South
Centerville 4508204, Ohio 5165418 45459
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Adena Regional Medical Center
Chillicothe 4828890, Ohio 5165418 45601
Contact:
Site Public Contact
877-779-7585
Jeffh@columbusccop.org

University of Cincinnati Cancer Center-UC Medical Center
Cincinnati 4508722, Ohio 5165418 45219
Contact:
Site Public Contact
513-584-7698
cancer@uchealth.com

Good Samaritan Hospital - Cincinnati
Cincinnati 4508722, Ohio 5165418 45220
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Bethesda North Hospital
Cincinnati 4508722, Ohio 5165418 45242
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

TriHealth Cancer Institute-Westside
Cincinnati 4508722, Ohio 5165418 45247
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

TriHealth Cancer Institute-Anderson
Cincinnati 4508722, Ohio 5165418 45255
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Case Western Reserve University
Cleveland 5150529, Ohio 5165418 44106
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Ohio State University Comprehensive Cancer Center
Columbus 4509177, Ohio 5165418 43210
Contact:
Site Public Contact
800-293-5066
Jamesline@osumc.edu

Mount Carmel East Hospital
Columbus 4509177, Ohio 5165418 43213
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

The Mark H Zangmeister Center
Columbus 4509177, Ohio 5165418 43219
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Mount Carmel Health Center West
Columbus 4509177, Ohio 5165418 43222
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Miami Valley Hospital
Dayton 4509884, Ohio 5165418 45409
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Premier Blood and Cancer Center
Dayton 4509884, Ohio 5165418 45409
Contact:
Site Public Contact
937-276-8320

Miami Valley Hospital North
Dayton 4509884, Ohio 5165418 45415
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Atrium Medical Center-Middletown Regional Hospital
Franklin 4512203, Ohio 5165418 45005-1066
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Central Ohio Breast and Endocrine Surgery
Gahanna 5155393, Ohio 5165418 43230
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Miami Valley Cancer Care and Infusion
Greenville 5156493, Ohio 5165418 45331
Contact:
Site Public Contact
937-569-7515

Mount Carmel Grove City Hospital
Grove City 4513409, Ohio 5165418 43123
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Zangmeister Center Grove City
Grove City 4513409, Ohio 5165418 43123
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Fairfield Medical Center
Lancaster 4516233, Ohio 5165418 43130
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Saint Rita's Medical Center
Lima 5160783, Ohio 5165418 45801
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Marietta Memorial Hospital
Marietta 4517586, Ohio 5165418 45750
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Memorial Hospital
Marysville 5162077, Ohio 5165418 43040
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Toledo Clinic Cancer Centers-Maumee
Maumee 5162137, Ohio 5165418 43537
Contact:
Site Public Contact
pshoup@toledoclinic.com

Knox Community Hospital
Mount Vernon 5163799, Ohio 5165418 43050
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Mount Carmel New Albany Surgical Hospital
New Albany 5164202, Ohio 5165418 43054
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Licking Memorial Hospital
Newark 5164466, Ohio 5165418 43055
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Newark Radiation Oncology
Newark 5164466, Ohio 5165418 43055
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Mercy Health Perrysburg Cancer Center
Perrysburg 5166516, Ohio 5165418 43551
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Southern Ohio Medical Center
Portsmouth 4521816, Ohio 5165418 45662
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

UH Seidman Cancer Center at Firelands Regional Medical Center
Sandusky 5170691, Ohio 5165418 44870
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Springfield Regional Cancer Center
Springfield 4525353, Ohio 5165418 45504
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Springfield Regional Medical Center
Springfield 4525353, Ohio 5165418 45504
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Mercy Health - Saint Vincent Hospital
Toledo 5174035, Ohio 5165418 43608
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Mercy Health - Saint Anne Hospital
Toledo 5174035, Ohio 5165418 43623
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Mercy Health Sylvania Radiation Oncology Center
Toledo 5174035, Ohio 5165418 43623
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Toledo Clinic Cancer Centers-Toledo
Toledo 5174035, Ohio 5165418 43623
Contact:
Site Public Contact
800-444-3561

Upper Valley Medical Center
Troy 5174358, Ohio 5165418 45373
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

University of Cincinnati Cancer Center-West Chester
West Chester 4520522, Ohio 5165418 45069
Contact:
Site Public Contact
513-584-7698
cancer@uchealth.com

Saint Ann's Hospital
Westerville 5176472, Ohio 5165418 43081
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center
Wilmington 4528463, Ohio 5165418 45177
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Genesis Healthcare System Cancer Care Center
Zanesville 4528923, Ohio 5165418 43701
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Mercy Hospital Oklahoma City
Oklahoma City 4544349, Oklahoma 4544379 73120
Contact:
Site Public Contact
405-752-3402

Saint Alphonsus Cancer Care Center-Baker City
Baker City 5712169, Oregon 5744337 97814
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Saint Alphonsus Cancer Care Center-Ontario
Ontario 5744166, Oregon 5744337 97914
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Lehigh Valley Hospital-Cedar Crest
Allentown 5178127, Pennsylvania 6254927 18103
Contact:
Site Public Contact
610-402-9543
Morgan_M.Horton@lvhn.org

Lehigh Valley Hospital - Muhlenberg
Bethlehem 5180225, Pennsylvania 6254927 18017
Contact:
Site Public Contact
610-402-9543
Morgan_M.Horton@lvhn.org

Geisinger Medical Center
Danville 5186327, Pennsylvania 6254927 17822
Contact:
Site Public Contact
570-271-5251
HemonCCTrials@geisinger.edu

Pocono Medical Center
East Stroudsburg 5188075, Pennsylvania 6254927 18301
Contact:
Site Public Contact
610-402-9543
Morgan_M.Horton@lvhn.org

Geisinger Medical Center-Cancer Center Hazleton
Hazleton 5193011, Pennsylvania 6254927 18201
Contact:
Site Public Contact
570-459-2901
HemonCCTrials@geisinger.edu

Lehigh Valley Hospital-Hazleton
Hazleton 5193011, Pennsylvania 6254927 18201
Contact:
Site Public Contact
610-402-9543
Morgan_M.Horton@lvhn.org

Geisinger Medical Oncology-Lewisburg
Lewisburg 5197842, Pennsylvania 6254927 17837
Contact:
Site Public Contact
570-374-8555
HemonCCTrials@geisinger.edu

Geisinger Cancer Services-Pottsville
Pottsville 5207080, Pennsylvania 6254927 17901
Contact:
Site Public Contact
800-275-6401
HemonCCTrials@geisinger.edu

Community Medical Center
Scranton 5211303, Pennsylvania 6254927 18510
Contact:
Site Public Contact
570-703-4768
HemonCCTrials@geisinger.edu

Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre 5219488, Pennsylvania 6254927 18711
Contact:
Site Public Contact
570-271-5251
HemonCCTrials@geisinger.edu

Asplundh Cancer Pavilion
Willow Grove 5219619, Pennsylvania 6254927 19090
Contact:
Site Public Contact
215-600-9151
ONCTrialNow@jefferson.edu

Gibbs Cancer Center-Gaffney
Gaffney 4579418, South Carolina 4597040 29341
Contact:
Site Public Contact
864-560-6104
kmertz-rivera@gibbscc.org

Gibbs Cancer Center-Pelham
Greer 4580599, South Carolina 4597040 29651
Contact:
Site Public Contact
864-560-6104
kmertz-rivera@gibbscc.org

North Grove Medical Park
Spartanburg 4597200, South Carolina 4597040 29303
Contact:
Site Public Contact
864-560-6812

Spartanburg Medical Center
Spartanburg 4597200, South Carolina 4597040 29303
Contact:
Site Public Contact
864-560-6104
kmertz-rivera@gibbscc.org

Spartanburg Medical Center - Mary Black Campus
Spartanburg 4597200, South Carolina 4597040 29307
Contact:
Site Public Contact
864-560-6812

MGC Hematology Oncology-Union
Union 4599214, South Carolina 4597040 29379
Contact:
Site Public Contact
864-560-6104
kmertz-rivera@gibbscc.org

Sanford Cancer Center Oncology Clinic
Sioux Falls 5231851, South Dakota 5769223 57104
Contact:
Site Public Contact
605-312-3320
OncologyClinicTrialsSF@sanfordhealth.org

Sanford USD Medical Center - Sioux Falls
Sioux Falls 5231851, South Dakota 5769223 57117-5134
Contact:
Site Public Contact
605-312-3320
OncologyClinicalTrialsSF@SanfordHealth.org

Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners 5233780, Vermont 5242283 05602
Contact:
Site Public Contact
802-225-5400

University of Vermont Medical Center
Burlington 5234372, Vermont 5242283 05401
Contact:
Site Public Contact
802-656-4101
rpo@uvm.edu

University of Vermont and State Agricultural College
Burlington 5234372, Vermont 5242283 05405
Contact:
Site Public Contact
802-656-8990
rpo@uvm.edu

Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton 5788054, Washington 5815135 98310
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Jefferson Healthcare
Port Townsend 5807239, Washington 5815135 98368
Contact:
Site Public Contact
360-344-3091

Saint Michael Cancer Center
Silverdale 5810490, Washington 5815135 98383
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Duluth Clinic Ashland
Ashland 5244247, Wisconsin 5279468 54806
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Northwest Wisconsin Cancer Center
Ashland 5244247, Wisconsin 5279468 54806
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Marshfield Clinic-Chippewa Center
Chippewa Falls 5248511, Wisconsin 5279468 54729
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Marshfield Medical Center-EC Cancer Center
Eau Claire 5251436, Wisconsin 5279468 54701
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Essentia Health-Hayward Clinic
Hayward 5255882, Wisconsin 5279468 54843
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Marshfield Medical Center - Ladysmith
Ladysmith 5259048, Wisconsin 5279468 54848
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Marshfield Medical Center-Marshfield
Marshfield 5261969, Wisconsin 5279468 54449
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226
Contact:
Site Public Contact
414-805-3666

Marshfield Clinic-Minocqua Center
Minocqua 5263156, Wisconsin 5279468 54548
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

ProHealth D N Greenwald Center
Mukwonago 5263965, Wisconsin 5279468 53149
Contact:
Site Public Contact
research.institute@phci.org

ProHealth Oconomowoc Memorial Hospital
Oconomowoc 5265499, Wisconsin 5279468 53066
Contact:
Site Public Contact
262-928-7878

Marshfield Medical Center-Rice Lake
Rice Lake 5268798, Wisconsin 5279468 54868
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Essentia Health-Spooner Clinic
Spooner 5274034, Wisconsin 5279468 54801
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Marshfield Medical Center-River Region at Stevens Point
Stevens Point 5274644, Wisconsin 5279468 54482
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Essentia Health Saint Mary's Hospital - Superior
Superior 5275191, Wisconsin 5279468 54880
Contact:
Site Public Contact
701-364-6272

ProHealth Waukesha Memorial Hospital
Waukesha 5278052, Wisconsin 5279468 53188
Contact:
Site Public Contact
262-928-7632

UW Cancer Center at ProHealth Care
Waukesha 5278052, Wisconsin 5279468 53188
Contact:
Site Public Contact
262-928-5539
Chanda.miller@phci.org

Marshfield Clinic-Wausau Center
Wausau 5278120, Wisconsin 5279468 54401
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Marshfield Medical Center - Weston
Weston 5278693, Wisconsin 5279468 54476
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids 5279436, Wisconsin 5279468 54494
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Billings Clinic-Cody
Cody 5821593, Wyoming 5843591 82414
Contact:
Site Public Contact
800-996-2663
research@billingsclinic.org

Welch Cancer Center
Sheridan 5838198, Wyoming 5843591 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.