Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Stage IIIB-IV Melanoma, The PET-Stop Trial
A Phase II Study of Biomarker Driven Early Discontinuation of Anti-PD-1 Therapy in Patients With Advanced Melanoma (PET-Stop)
3 other identifiers
interventional
150
1 country
482
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2021
Longer than P75 for phase_2
482 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2020
CompletedFirst Posted
Study publicly available on registry
July 8, 2020
CompletedStudy Start
First participant enrolled
February 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 29, 2026
May 5, 2026
April 1, 2026
5.6 years
June 26, 2020
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Event free survival (EFS) rate (Arm A)
Event is defined as recurrence, progression or melanoma-specific death. The distribution of EFS will be evaluated using the method of Kaplan-Meier.
At 12 months
Secondary Outcomes (5)
Rates of pathologic response (Arm B)
After 12 months of anti-PD-1 therapy
EFS
At 24 months
Overall survival
At 24 months
Percentage of patients who remain on treatment beyond 12 months
Up to 5 years
Incidence rates of treatment-related adverse events -12 months from start of treatment in patients who discontinue anti-PD-1 therapy at 12 months (Arm A) and in patients who continue anti-PD-1 therapy beyond 12 months (Arm B)
Up to 5 years
Other Outcomes (4)
Determine FDG-PET/CT positivity between the local site read and central review
Up to 5 years
Metabolic response on serial FDG-PET/CT
Baseline to 12 months of anti-PD-1 therapy
Metabolic response on serial FDG-PET/CT
12 months to 24 months after start of anti-PD-1 therapy
- +1 more other outcomes
Study Arms (3)
Arm A (active surveillance)
EXPERIMENTALPatients 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 (nivolumab, pembrolizumab, ipilimumab)
ACTIVE COMPARATORPatients 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.
Standard of Care (nivolumab, pembrolizumab, ipilimumab)
OTHERPatients 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.
Interventions
Given IV
Given IV
Undergo active surveillance
Given IV
Eligibility Criteria
You may qualify if:
- 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
- +18 more criteria
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ECOG-ACRIN Cancer Research Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (482)
Thomas Hospital
Fairhope, Alabama, 36532, United States
Mobile Infirmary Medical Center
Mobile, Alabama, 36607, United States
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701, United States
Cancer Center at Saint Joseph's
Phoenix, Arizona, 85004, United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903, United States
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas, 71913, United States
CARTI Cancer Center
Little Rock, Arkansas, 72205, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531, United States
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California, 93420, United States
Mercy Cancer Center - Carmichael
Carmichael, California, 95608, United States
Mercy San Juan Medical Center
Carmichael, California, 95608, United States
Kaiser Permanente Dublin
Dublin, California, 94568, United States
Mercy Cancer Center - Elk Grove
Elk Grove, California, 95758, United States
Kaiser Permanente-Fremont
Fremont, California, 94538, United States
Fresno Cancer Center
Fresno, California, 93720, United States
Kaiser Permanente-Fresno
Fresno, California, 93720, United States
The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, California, 90025, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Mercy Cancer Center
Merced, California, 95340, United States
Kaiser Permanente-Modesto
Modesto, California, 95356, United States
Kaiser Permanente Oakland-Broadway
Oakland, California, 94611, United States
Kaiser Permanente-Oakland
Oakland, California, 94611, United States
Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California, 95670, United States
Kaiser Permanente- Marshall Medical Offices
Redwood City, California, 94063, United States
Kaiser Permanente-Richmond
Richmond, California, 94801, United States
Mercy Cancer Center - Rocklin
Rocklin, California, 95765, United States
Rohnert Park Cancer Center
Rohnert Park, California, 94928, United States
Kaiser Permanente-Roseville
Roseville, California, 95661, United States
The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California, 95678, United States
Kaiser Permanente Downtown Commons
Sacramento, California, 95814, United States
Mercy Cancer Center - Sacramento
Sacramento, California, 95816, United States
Kaiser Permanente-South Sacramento
Sacramento, California, 95823, United States
South Sacramento Cancer Center
Sacramento, California, 95823, United States
Kaiser Permanente-San Francisco
San Francisco, California, 94115, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, 95119, United States
Kaiser Permanente San Leandro
San Leandro, California, 94577, United States
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California, 93401, United States
Kaiser San Rafael-Gallinas
San Rafael, California, 94903, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051, United States
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California, 93444, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403, United States
Kaiser Permanente Cancer Treatment Center
South San Francisco, California, 94080, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080, United States
Kaiser Permanente-Stockton
Stockton, California, 95210, United States
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, 95688, United States
Kaiser Permanente-Vallejo
Vallejo, California, 94589, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596, United States
BASS Medical Group - Lennon
Walnut Creek, California, 94598, United States
Woodland Memorial Hospital
Woodland, California, 95695, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
Boulder Community Foothills Hospital
Boulder, Colorado, 80303, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304, United States
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, 80112, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907, United States
Saint Francis Cancer Center
Colorado Springs, Colorado, 80923, United States
Kaiser Permanente-Franklin
Denver, Colorado, 80205, United States
The Women's Imaging Center
Denver, Colorado, 80209, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220, United States
Rose Medical Center
Denver, Colorado, 80220, United States
Western Surgical Care
Denver, Colorado, 80220, United States
Mercy Medical Center
Durango, Colorado, 81301, United States
Southwest Oncology PC
Durango, Colorado, 81301, United States
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, 80113, United States
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado, 80113, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
The Melanoma and Skin Cancer Institute
Englewood, Colorado, 80113, United States
Kaiser Permanente-Rock Creek
Lafayette, Colorado, 80026, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, 80228, United States
Saint Anthony Hospital
Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, 80120, United States
Littleton Adventist Hospital
Littleton, Colorado, 80122, United States
Kaiser Permanente-Lone Tree
Lone Tree, Colorado, 80124, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, 80124, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
Longmont United Hospital
Longmont, Colorado, 80501, United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, 80501, United States
Parker Adventist Hospital
Parker, Colorado, 80138, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004, United States
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, 80260, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442, United States
Holy Cross Hospital
Fort Lauderdale, Florida, 33308, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, 33176, United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, 33324, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Northside Hospital - Duluth
Duluth, Georgia, 30096, United States
Northside Hospital - Gwinnett
Lawrenceville, Georgia, 30046, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814, United States
Walter Knox Memorial Hospital
Emmett, Idaho, 83617, United States
Idaho Urologic Institute-Meridian
Meridian, Idaho, 83642, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854, United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864, United States
Saint Anthony's Health
Alton, Illinois, 62002, United States
Rush - Copley Medical Center
Aurora, Illinois, 60504, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902, United States
SIH Cancer Institute
Carterville, Illinois, 62918, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Centralia Oncology Clinic
Centralia, Illinois, 62801, United States
Saint Mary's Hospital
Centralia, Illinois, 62801, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Illinois
Chicago, Illinois, 60612, United States
Carle at The Riverfront
Danville, Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Illinois CancerCare-Dixon
Dixon, Illinois, 61021, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864, United States
Edward Hospital/Cancer Center
Naperville, Illinois, 60540, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Valley Radiation Oncology
Peru, Illinois, 61354, United States
Edward Hospital/Cancer Center?Plainfield
Plainfield, Illinois, 60585, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Southwest Illinois Health Services LLP
Swansea, Illinois, 62226, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
The Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Illinois CancerCare - Washington
Washington, Illinois, 61571, United States
Rush-Copley Healthcare Center
Yorkville, Illinois, 60560, United States
Reid Health
Richmond, Indiana, 47374, United States
Mary Greeley Medical Center
Ames, Iowa, 50010, United States
McFarland Clinic - Ames
Ames, Iowa, 50010, United States
Mission Cancer and Blood - Ankeny
Ankeny, Iowa, 50023, United States
McFarland Clinic - Boone
Boone, Iowa, 50036, United States
Saint Anthony Regional Hospital
Carroll, Iowa, 51401, United States
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325, United States
Mission Cancer and Blood - West Des Moines
Clive, Iowa, 50325, United States
Alegent Health Mercy Hospital
Council Bluffs, Iowa, 51503, United States
Greater Regional Medical Center
Creston, Iowa, 50801, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Mission Cancer and Blood - Des Moines
Des Moines, Iowa, 50309, United States
Broadlawns Medical Center
Des Moines, Iowa, 50314, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
Mission Cancer and Blood - Laurel
Des Moines, Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501, United States
Trinity Regional Medical Center
Fort Dodge, Iowa, 50501, United States
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129, United States
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158, United States
Methodist West Hospital
West Des Moines, Iowa, 50266-7700, United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266, United States
Central Care Cancer Center - Garden City
Garden City, Kansas, 67846, United States
Central Care Cancer Center - Great Bend
Great Bend, Kansas, 67530, United States
Flaget Memorial Hospital
Bardstown, Kentucky, 40004, United States
Commonwealth Cancer Center-Corbin
Corbin, Kentucky, 40701, United States
Saint Joseph Hospital
Lexington, Kentucky, 40504, United States
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky, 40504, United States
Saint Joseph Hospital East
Lexington, Kentucky, 40509, United States
Saint Joseph London
London, Kentucky, 40741, United States
Jewish Hospital
Louisville, Kentucky, 40202, United States
Saints Mary and Elizabeth Hospital
Louisville, Kentucky, 40215, United States
UofL Health Medical Center Northeast
Louisville, Kentucky, 40245, United States
Saint Joseph Mount Sterling
Mount Sterling, Kentucky, 40353, United States
Mercy Health - Paducah Medical Oncology and Hematology
Paducah, Kentucky, 42003, United States
Jewish Hospital Medical Center South
Shepherdsville, Kentucky, 40165, United States
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, 21237, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Hickman Cancer Center
Adrian, Michigan, 49221, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114, United States
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188, United States
Trinity Health Medical Center - Canton
Canton, Michigan, 48188, United States
Caro Cancer Center
Caro, Michigan, 48723, United States
Chelsea Hospital
Chelsea, Michigan, 48118, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118, United States
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan, 48346, United States
Newland Medical Associates-Clarkston
Clarkston, Michigan, 48346, United States
Ascension Saint John Hospital
Detroit, Michigan, 48236, United States
Great Lakes Cancer Management Specialists-Doctors Park
East China, Michigan, 48054, United States
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan, 48503, United States
Genesee Hematology Oncology PC
Flint, Michigan, 48503, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503, United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503, United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503, United States
Academic Hematology Oncology Specialists
Grosse Pointe Woods, Michigan, 48236, United States
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan, 48236, United States
Michigan Breast Specialists-Grosse Pointe Woods
Grosse Pointe Woods, Michigan, 48236, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Ascension Borgess Cancer Center
Kalamazoo, Michigan, 49009, United States
Borgess Medical Center
Kalamazoo, Michigan, 49048, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912, United States
Hope Cancer Clinic
Livonia, Michigan, 48154, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154, United States
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, Michigan, 48044, United States
Michigan Breast Specialists-Macomb Township
Macomb, Michigan, 48044, United States
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan, 48453, United States
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan, 48162, United States
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444, United States
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120, United States
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444, United States
Hope Cancer Center
Pontiac, Michigan, 48341, United States
Michigan Healthcare Professionals Pontiac
Pontiac, Michigan, 48341, United States
Newland Medical Associates-Pontiac
Pontiac, Michigan, 48341, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341, United States
Corewell Health Reed City Hospital
Reed City, Michigan, 49677, United States
Great Lakes Cancer Management Specialists-Rochester Hills
Rochester Hills, Michigan, 48309, United States
Ascension Saint Mary's Hospital
Saginaw, Michigan, 48601, United States
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan, 48604, United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085, United States
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, Michigan, 48312, United States
Ascension Saint Joseph Hospital
Tawas City, Michigan, 48764, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Advanced Breast Care Center PLLC
Warren, Michigan, 48088, United States
Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren, Michigan, 48093, United States
Macomb Hematology Oncology PC
Warren, Michigan, 48093, United States
Michigan Breast Specialists-Warren
Warren, Michigan, 48093, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan, 48661, United States
University of Michigan Health - West
Wyoming, Michigan, 49519, United States
Huron Gastroenterology PC
Ypsilanti, Michigan, 48106, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197, United States
Riverwood Healthcare Center
Aitkin, Minnesota, 56431, United States
Essentia Health - Baxter Clinic
Baxter, Minnesota, 56425, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401, United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636, United States
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501, United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805, United States
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805, United States
Miller-Dwan Hospital
Duluth, Minnesota, 55805, United States
Essentia Health - Ely Clinic
Ely, Minnesota, 55731, United States
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota, 56537, United States
Essentia Health - Fosston
Fosston, Minnesota, 56542, United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746, United States
Essentia Health - International Falls Clinic
International Falls, Minnesota, 56649, United States
Essentia Health - Moose Lake Clinic
Moose Lake, Minnesota, 55767, United States
Essentia Health - Park Rapids
Park Rapids, Minnesota, 56470, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
Essentia Health Sandstone
Sandstone, Minnesota, 55072, United States
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota, 56701, United States
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792, United States
Sanford Cancer Center Worthington
Worthington, Minnesota, 56187, United States
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, 63011, United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613, United States
Cox Cancer Center Branson
Branson, Missouri, 65616, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Southeast Cancer Center
Cape Girardeau, Missouri, 63703, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
Parkland Health Center - Farmington
Farmington, Missouri, 63640, United States
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, 65109, United States
Freeman Health System
Joplin, Missouri, 64804, United States
Mercy Hospital Joplin
Joplin, Missouri, 64804, United States
Lake Regional Hospital
Osage Beach, Missouri, 65065, United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, 65401, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri, 63670, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, 63109, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mercy Hospital South
St Louis, Missouri, 63128, United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080, United States
BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri, 63127, United States
Mercy Hospital Washington
Washington, Missouri, 63090, United States
Community Hospital of Anaconda
Anaconda, Montana, 59711, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Community Medical Center
Missoula, Montana, 59804, United States
Nebraska Cancer Specialists/Oncology Hematology West PC
Grand Island, Nebraska, 68803, United States
CHI Health Good Samaritan
Kearney, Nebraska, 68847, United States
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510, United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
Alegent Health Lakeside Hospital
Omaha, Nebraska, 68130, United States
Creighton University Medical Center
Omaha, Nebraska, 68131, United States
Midlands Community Hospital
Papillion, Nebraska, 68046, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Jersey Shore Medical Center
Neptune City, New Jersey, 07753, United States
Riverview Medical Center/Booker Cancer Center
Red Bank, New Jersey, 07701, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
East White Plains, New York, 10604, United States
Glens Falls Hospital
Glens Falls, New York, 12801, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Duke Cancer Institute Cary
Cary, North Carolina, 27518, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
East Carolina University
Greenville, North Carolina, 27834, United States
Duke Women's Cancer Care Raleigh
Raleigh, North Carolina, 27607, United States
Duke Raleigh Hospital
Raleigh, North Carolina, 27609, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103, United States
Sanford South University Medical Center
Fargo, North Dakota, 58103, United States
Southpointe-Sanford Medical Center Fargo
Fargo, North Dakota, 58103, United States
Sanford Medical Center Fargo
Fargo, North Dakota, 58104, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Essentia Health - Jamestown Clinic
Jamestown, North Dakota, 58401, United States
UH Seidman Cancer Center at UH Avon Health Center
Avon, Ohio, 44011, United States
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122, United States
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431, United States
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714, United States
Saint Elizabeth Boardman Hospital
Boardman, Ohio, 44512, United States
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220, United States
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236, United States
Bethesda North Hospital
Cincinnati, Ohio, 45242, United States
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247, United States
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio, 45255, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Mount Carmel East Hospital
Columbus, Ohio, 43213, United States
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Grant Medical Center
Columbus, Ohio, 43215, United States
The Mark H Zangmeister Center
Columbus, Ohio, 43219, United States
Mount Carmel Health Center West
Columbus, Ohio, 43222, United States
Doctors Hospital
Columbus, Ohio, 43228, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Premier Blood and Cancer Center
Dayton, Ohio, 45409, United States
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415, United States
Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Columbus Oncology and Hematology Associates
Dublin, Ohio, 43016, United States
Dublin Methodist Hospital
Dublin, Ohio, 43016, United States
Armes Family Cancer Center
Findlay, Ohio, 45840, United States
Blanchard Valley Hospital
Findlay, Ohio, 45840, United States
Orion Cancer Care
Findlay, Ohio, 45840, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005, United States
Central Ohio Breast and Endocrine Surgery
Gahanna, Ohio, 43230, United States
Dayton Physicians LLC-Wayne
Greenville, Ohio, 45331, United States
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Mount Carmel Grove City Hospital
Grove City, Ohio, 43123, United States
Zangmeister Center Grove City
Grove City, Ohio, 43123, United States
Greater Dayton Cancer Center
Kettering, Ohio, 45409, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
Saint Rita's Medical Center
Lima, Ohio, 45801, United States
OhioHealth Mansfield Hospital
Mansfield, Ohio, 44903, United States
Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
OhioHealth Marion General Hospital
Marion, Ohio, 43302, United States
Memorial Hospital
Marysville, Ohio, 43040, United States
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, 43537, United States
Knox Community Hospital
Mount Vernon, Ohio, 43050, United States
Mount Carmel New Albany Surgical Hospital
New Albany, Ohio, 43054, United States
Licking Memorial Hospital
Newark, Ohio, 43055, United States
Newark Radiation Oncology
Newark, Ohio, 43055, United States
Mercy Health Perrysburg Cancer Center
Perrysburg, Ohio, 43551, United States
Southern Ohio Medical Center
Portsmouth, Ohio, 45662, United States
UH Seidman Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio, 44870, United States
Springfield Regional Cancer Center
Springfield, Ohio, 45504, United States
Springfield Regional Medical Center
Springfield, Ohio, 45504, United States
Mercy Health - Saint Vincent Hospital
Toledo, Ohio, 43608, United States
Mercy Health - Saint Anne Hospital
Toledo, Ohio, 43623, United States
Mercy Health Sylvania Radiation Oncology Center
Toledo, Ohio, 43623, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, 43623, United States
Dayton Physicians LLC - Troy
Troy, Ohio, 45373, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Saint Joseph Warren Hospital
Warren, Ohio, 44484, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069, United States
Saint Ann's Hospital
Westerville, Ohio, 43081, United States
Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center
Wilmington, Ohio, 45177, United States
Saint Elizabeth Youngstown Hospital
Youngstown, Ohio, 44501, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, 43701, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120, United States
Saint Alphonsus Cancer Care Center-Baker City
Baker City, Oregon, 97814, United States
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, 97914, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201, United States
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania, 18201, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, 17901, United States
Community Medical Center
Scranton, Pennsylvania, 18510, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090, United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651, United States
North Grove Medical Park
Spartanburg, South Carolina, 29303, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Spartanburg Medical Center - Mary Black Campus
Spartanburg, South Carolina, 29307, United States
MGC Hematology Oncology-Union
Union, South Carolina, 29379, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Saint Joseph Regional Cancer Center
Bryan, Texas, 77802, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
University of Vermont and State Agricultural College
Burlington, Vermont, 05405, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, 98310, United States
Highline Medical Center-Main Campus
Burien, Washington, 98166, United States
Saint Elizabeth Hospital
Enumclaw, Washington, 98022, United States
Saint Francis Hospital
Federal Way, Washington, 98003, United States
Saint Clare Hospital
Lakewood, Washington, 98499, United States
Jefferson Healthcare
Port Townsend, Washington, 98368, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, 98370, United States
Saint Michael Cancer Center
Silverdale, Washington, 98383, United States
Franciscan Research Center-Northwest Medical Plaza
Tacoma, Washington, 98405, United States
Northwest Medical Specialties PLLC
Tacoma, Washington, 98405, United States
Duluth Clinic Ashland
Ashland, Wisconsin, 54806, United States
Northwest Wisconsin Cancer Center
Ashland, Wisconsin, 54806, United States
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701, United States
Essentia Health-Hayward Clinic
Hayward, Wisconsin, 54843, United States
Marshfield Medical Center - Ladysmith
Ladysmith, Wisconsin, 54848, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548, United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868, United States
Essentia Health-Spooner Clinic
Spooner, Wisconsin, 54801, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482, United States
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin, 54880, United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188, United States
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, 54401, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494, United States
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming, 82001, United States
Billings Clinic-Cody
Cody, Wyoming, 82414, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Geoffrey T Gibney
ECOG-ACRIN Cancer Research Group
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2020
First Posted
July 8, 2020
Study Start
February 9, 2021
Primary Completion (Estimated)
August 29, 2026
Study Completion (Estimated)
August 29, 2026
Last Updated
May 5, 2026
Record last verified: 2026-04