Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation
Randomized Phase II Trial of Encorafenib and Cetuximab With or Without Nivolumab (NSC #748726) for Patients With Previously Treated, Microsatellite Stable, BRAFV600E Metastatic and/or Unresectable Colorectal Cancer
3 other identifiers
interventional
84
2 countries
286
Brief Summary
This phase II trial tests whether adding nivolumab to the usual treatment (encorafenib and cetuximab) works better than the usual treatment alone to shrink tumors in patients with colorectal cancer that has spread to other places in the body (metastatic) or that cannot be removed by surgery (unresectable) and whose tumor has a mutation in a gene called BRAF. Encorafenib is in a class of medications called kinase inhibitors. It is used in patients whose cancer has a certain mutation (change) in the BRAF gene. It works by blocking the action of mutated BRAF that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab in combination with encorafenib and cetuximab may be more effective than encorafenib and cetuximab alone at stopping tumor growth and spreading in patients with metastatic or unresectable BRAF-mutant colorectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2022
Typical duration for phase_2
286 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
April 1, 2022
CompletedFirst Posted
Study publicly available on registry
April 4, 2022
CompletedStudy Start
First participant enrolled
July 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
April 21, 2026
March 1, 2026
4.2 years
April 1, 2022
April 18, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS)
Conducted in all eligible participants according to the intent-to-treat principle using the stratified log rank test when a total of 66 PFS events have been observed. Estimated using the Kaplan-Meier method and compared using the stratified log rank test.
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years
Secondary Outcomes (5)
Overall response rate (ORR)
Up to 3 years
Overall survival (OS)
From date of registration to date of death due to any cause, assessed up to 3 years
Duration of response (DoR)
From date of first documentation of confirmed response (complete response or partial response) to date of first documentation of progression or symptomatic deterioration or death due to any cause among participants who achieve a response, up to 3 years
Immune related progression-free survival (irRC-PFS) in Arm I
From date of registration to date of initial documentation of irRC-progression that has subsequently been confirmed or symptomatic deterioration, or death due to any cause, assessed up to 3 years
Incidence of adverse events
Up to 3 years
Study Arms (2)
Arm I (encorafenib, cetuximab, nivolumab)
EXPERIMENTALPatients receive encorafenib PO QD on days 1-28, cetuximab IV on days 1 and 15, and nivolumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm II (encorafenib, cetuximab)
ACTIVE COMPARATORPatients receive encorafenib PO QD on days 1-28 and cetuximab IV on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Given PO
Given IV
Eligibility Criteria
You may qualify if:
- Participants must have a histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum. The date of diagnosis will be determined according to the pathologic date of diagnosis
- Participants must have measurable disease according to RECIST1.1 criteria. Computed tomography (CT) scans or magnetic resonance imaging (MRIs) used to assess measurable disease must have been completed within 28 days prior to registration. CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form
- Participants must have documented unresectable and/or metastatic disease on CT or MRI imaging. All disease must be assessed and documented on the Baseline Tumor Assessment Form
- Participants must have BRAF\^V600E mutated colorectal cancer as tested in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory
- Participants must have proficient mismatch repair (pMMR) or microsatellite stable (MSS) status as tested in a CLIA-certified laboratory and documented by the treating clinician. Proficient mismatch repair status can be determined by intact expression by immunohistochemistry of all 4 mismatch repair proteins (MLH1, MSH2, MSH6, and PMS2). Microsatellite instability can be determined by polymerase chain reaction (PCR)
- Participants with brain metastases must have completed surgery or radiation therapy \>= 28 days prior to registration. These participants must have a CT or MRI of the brain showing no new or enlarging lesions within 42 days prior to registration. These participants must also be neurologically asymptomatic and without corticosteroid treatment for at least 7 days prior to registration. Metastatic brain parenchymal disease must have been treated and participant must be off steroids for 7 days prior to registration. The presence of leptomeningeal disease (LMD) is not considered stable disease, and participants with LMD are not eligible for this study
- Participants with known evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to registration
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection who are currently on treatment must have an undetectable HCV viral load within 28 days prior to registration
- Participants must have had one or two prior regimens of systemic chemotherapy for metastatic or locally advanced, unresectable disease. (A maintenance regimen of 5-fluorouracil or capecitabine, with or without bevacizumab, should not be counted as a separate line of treatment. The re-introduction of an initially successful induction regimen will not be counted as one additional line of treatment). Prior treatment for metastatic disease is not required for patients who experienced disease recurrence during or within 6 months of completion of adjuvant chemotherapy
- Participants must be of age \>= 18 years at the time of informed consent
- Participants must have a Zubrod performance status of 0 or 1
- Participants must have a complete medical history and physical exam within 28 days prior to registration
- Absolute neutrophil count \>= 1.0 x 10\^3/uL (within 28 days prior to registration)
- Hemoglobin \>= 9 g/dL (within 28 days prior to registration)
- Platelets \>= 75 x 10\^3/uL (within 28 days prior to registration)
- +11 more criteria
You may not qualify if:
- Participants must not have a known positive serology for human immunodeficiency virus (HIV). Encorafenib is contraindicated with concomitant use of non-nucleoside analog reverse transcriptase inhibitors like efavirenz and etravirine. In addition, it is recommended in the investigator brochure of encorafenib to avoid using encorafenib with protease inhibitors. Therefore, because all participants on this study would receive encorafenib for either randomized arm of treatment, participants with HIV who receive these components of highly active antiretroviral therapy (HAART) would be at high risk for complications of drug-drug interaction
- Participants must not have had prior treatment with a BRAF inhibitor (including, but not limited to, encorafenib, dabrafenib, or vemurafenib), MEK inhibitor (including, but not limited to, trametinib, selumetinib, or binimetinib), or ERK inhibitor (of note, regorafenib is not considered a BRAF inhibitor for the context of eligibility criteria)
- Participants must not have had prior treatment with anti-EGFR therapies
- Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
- Participants must not have a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration. Inhaled or topical steroids and adrenal replacement doses \< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if \< 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted, as long as there has been a washout period for corticosteroids of \>= 7 days prior to registration
- Participants must not have received a live vaccine within 30 days prior to study registration. Seasonal flu and COVID vaccines that do not contain a live virus are permitted
- Participants must not be receiving any other investigational agents
- Participants must not have impaired gastrointestinal function or disease that may significantly alter the absorption of study drug (e.g., ulcerative diseases, uncontrolled vomiting, malabsorption syndrome, small bowel resection with decreased intestinal absorption)
- Participants must not have a history of inflammatory bowel disease, (including ulcerative colitis and Crohn's disease), symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], systemic lupus erythematosus, autoimmune vasculitis \[e.g., Wegener's Granulomatosis\]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome and myasthenia gravis, multiple sclerosis).
- Note: Participants with Graves' disease will be allowed
- Participants must not have a history of pneumonitis that has required oral or intravenous (IV) steroids within the last 12 months
- Participants must not have a history of a grade 3 or 4 allergic reaction attributed to humanized or human monoclonal antibody therapy
- Participants must not have a history of a prior allogeneic tissue or solid organ transplant
- Participants must not have a history of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) within 6 months prior to study registration
- Participants must not have uncontrolled blood pressure and hypertension within 28 days prior to registration.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (286)
CTCA at Western Regional Medical Center
Goodyear, Arizona, 85338, 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
Kaiser Permanente-Fresno
Fresno, California, 93720, United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612, United States
Kaiser Permanente-Modesto
Modesto, California, 95356, United States
Kaiser Permanente-Oakland
Oakland, California, 94611, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Mercy Cancer Center - Rocklin
Rocklin, California, 95765, United States
Kaiser Permanente-Roseville
Roseville, California, 95661, 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
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
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080, United States
Kaiser Permanente-Vallejo
Vallejo, California, 94589, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596, United States
Woodland Memorial Hospital
Woodland, California, 95695, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909, United States
Memorial Hospital North
Colorado Springs, Colorado, 80920, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, 80528, United States
UCHealth Greeley Hospital
Greeley, Colorado, 80631, United States
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, 80129, United States
Medical Center of the Rockies
Loveland, Colorado, 80538, United States
CTCA at Southeastern Regional Medical Center
Newnan, Georgia, 30265, United States
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, 96819, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712, 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
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687, United States
Saint Luke's Cancer Institute - 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 Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, 83301, United States
Rush-Copley Medical Center
Aurora, Illinois, 60504, United States
Advocate Good Shepherd Hospital
Barrington, Illinois, 60010, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Centralia Oncology Clinic
Centralia, Illinois, 62801, United States
University of Illinois
Chicago, Illinois, 60612, United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657, United States
AMG Crystal Lake - Oncology
Crystal Lake, Illinois, 60014, 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
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Advocate Sherman Hospital
Elgin, Illinois, 60123, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Advocate South Suburban Hospital
Hazel Crest, Illinois, 60429, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
AMG Libertyville - Oncology
Libertyville, Illinois, 60048, United States
Condell Memorial Hospital
Libertyville, Illinois, 60048, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, 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
Springfield Memorial Hospital
Springfield, Illinois, 62781, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Illinois CancerCare - Washington
Washington, Illinois, 61571, United States
Rush-Copley Healthcare Center
Yorkville, Illinois, 60560, United States
Northwest Cancer Center - Crown Point
Crown Point, Indiana, 46307, United States
Northwest Oncology LLC
Dyer, Indiana, 46311, United States
Northwest Cancer Center - Hobart
Hobart, Indiana, 46342, United States
Saint Mary Medical Center
Hobart, Indiana, 46342, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237, United States
Saint Catherine Hospital
Indianapolis, Indiana, 46312, United States
Franciscan Saint Elizabeth Health - Lafayette East
Lafayette, Indiana, 47905, United States
Woodland Cancer Care Center
Michigan City, Indiana, 46360, United States
Franciscan Health Mooresville
Mooresville, Indiana, 46158, United States
The Community Hospital
Munster, Indiana, 46321, United States
Women's Diagnostic Center - Munster
Munster, Indiana, 46321, United States
Northwest Cancer Center - Valparaiso
Valparaiso, Indiana, 46383, United States
Mary Greeley Medical Center
Ames, Iowa, 50010, United States
McFarland Clinic - Ames
Ames, Iowa, 50010, United States
McFarland Clinic - Boone
Boone, Iowa, 50036, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501, United States
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129, United States
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158, United States
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805, United States
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808, United States
Ochsner Hematology Oncology North Shore - Covington (West Region)
Covington, Louisiana, 70433, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, 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
Chelsea Hospital
Chelsea, Michigan, 48118, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236, United States
Henry Ford River District Hospital
East China Township, Michigan, 48054, United States
Cancer Hematology Centers - Flint
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
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503, United States
Henry Ford Saint John Hospital - Academic
Grosse Pointe Woods, Michigan, 48236, United States
Henry Ford Saint John Hospital - Van Elslander
Grosse Pointe Woods, Michigan, 48236, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan, 49009, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154, United States
Henry Ford Saint John Hospital - Macomb Medical
Macomb, Michigan, 48044, 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
Henry Ford Health Providence Novi Hospital
Novi, Michigan, 48374, United States
Henry Ford Medical Center-Columbus
Novi, Michigan, 48377, United States
Corewell Health Reed City Hospital
Reed City, Michigan, 49677, United States
MyMichigan Medical Center Saginaw
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
Henry Ford Health Providence Southfield Hospital
Southfield, Michigan, 48075, United States
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, Michigan, 48312, United States
MyMichigan Medical Center Tawas
Tawas City, Michigan, 48764, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Henry Ford Health Warren Hospital
Warren, Michigan, 48093, United States
Henry Ford Warren Hospital - GLCMS
Warren, Michigan, 48093, United States
Macomb Hematology Oncology PC
Warren, Michigan, 48093, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322, 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
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636, United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Essentia Health Sandstone
Sandstone, Minnesota, 55072, United States
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, 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
Logan Health Medical Center
Kalispell, Montana, 59901, United States
Community Medical Center
Missoula, Montana, 59804, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756, United States
Hunterdon Medical Center
Flemington, New Jersey, 08822, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328, United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534, United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, 28546, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374, United States
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, 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
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
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005, United States
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331, United States
Mount Carmel Grove City Hospital
Grove City, Ohio, 43123, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
OhioHealth Mansfield Hospital
Mansfield, Ohio, 44903, United States
OhioHealth Marion General Hospital
Marion, Ohio, 43302, United States
Memorial Hospital
Marysville, Ohio, 43040, United States
Knox Community Hospital
Mount Vernon, Ohio, 43050, United States
Licking Memorial Hospital
Newark, Ohio, 43055, United States
Southern Ohio Medical Center
Portsmouth, Ohio, 45662, United States
Springfield Regional Cancer Center
Springfield, Ohio, 45504, United States
Springfield Regional Medical Center
Springfield, Ohio, 45504, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, 43623, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Saint Ann's Hospital
Westerville, Ohio, 43081, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, 43701, United States
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, 73505, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015, United States
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015, United States
Providence Newberg Medical Center
Newberg, Oregon, 97132, United States
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, 97914, United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, 18103, United States
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania, 18017, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, 79106, United States
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas, 75237, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas, 76104, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas, 75080, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, 05819, United States
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026, United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029, United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122, United States
United Hospital Center
Bridgeport, West Virginia, 26330, United States
West Virginia University Healthcare
Morgantown, West Virginia, 26506, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911, United States
Duluth Clinic Ashland
Ashland, Wisconsin, 54806, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105, United States
Aurora Saint Luke's South Shore
Cudahy, Wisconsin, 53110, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701, United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142, United States
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233, United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548, United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482, United States
Aurora Medical Center in Summit
Summit, Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476, United States
Puerto Rico Hematology Oncology Group
Bayamón, 00961, Puerto Rico
Centro Comprensivo de Cancer de UPR
San Juan, 00927, Puerto Rico
PROncology
San Juan, 00927, Puerto Rico
San Juan City Hospital
San Juan, 00936, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Van K Morris
SWOG Cancer Research Network
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2022
First Posted
April 4, 2022
Study Start
July 19, 2022
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
April 21, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
"NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page."