Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation

Program Status

Active, not recruiting

Phase

Phase 2

Prior Immunotherapy Allowed

No

CRC-directed Trial

Yes

Drugs

cetuximab, encorafenib, Nivolumab, Braftovi, Erbitux, Opdivo

Tags

MSS/ MMRp

Comments

Only for unresectable MSS CRC with a BRAF V600E mutation. Of note, stage III is also allowed, not only stage IV.
One or two prior lines of therapy required. It is possible for patients to enroll if they have not received treatment in the metastatic setting yet.
Trial compares the standard of care treatment cetuximab + encorafenib vs that SOC combination plus nivolumab (anti PD-1, Opdivo®; immunotherapy).

No prior BRAF, ERK or EGFR inhibitors allowed; no prior immunotherapy allowed.

Location Location Status
United States
CTCA at Western Regional Medical Center
Goodyear, Arizona 85338
Active, not recruiting
Mercy Cancer Center - Carmichael
Carmichael, California 95608
Active, not recruiting
Mercy San Juan Medical Center
Carmichael, California 95608
Active, not recruiting
Kaiser Permanente Dublin
Dublin, California 94568
Active, not recruiting
Mercy Cancer Center - Elk Grove
Elk Grove, California 95758
Active, not recruiting
Kaiser Permanente-Fremont
Fremont, California 94538
Active, not recruiting
Kaiser Permanente-Fresno
Fresno, California 93720
Active, not recruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California 92612
Active, not recruiting
Kaiser Permanente-Modesto
Modesto, California 95356
Active, not recruiting
Kaiser Permanente-Oakland
Oakland, California 94611
Active, not recruiting
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868
Active, not recruiting
Mercy Cancer Center - Rocklin
Rocklin, California 95765
Active, not recruiting
Kaiser Permanente-Roseville
Roseville, California 95661
Active, not recruiting
Kaiser Permanente Downtown Commons
Sacramento, California 95814
Active, not recruiting
Mercy Cancer Center - Sacramento
Sacramento, California 95816
Active, not recruiting
Kaiser Permanente-South Sacramento
Sacramento, California 95823
Active, not recruiting
Kaiser Permanente-San Francisco
San Francisco, California 94115
Active, not recruiting
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California 95119
Active, not recruiting
Kaiser Permanente San Leandro
San Leandro, California 94577
Active, not recruiting
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California 95051
Active, not recruiting
Kaiser Permanente-Santa Rosa
Santa Rosa, California 95403
Active, not recruiting
Kaiser Permanente-South San Francisco
South San Francisco, California 94080
Active, not recruiting
Kaiser Permanente-Vallejo
Vallejo, California 94589
Active, not recruiting
Kaiser Permanente-Walnut Creek
Walnut Creek, California 94596
Active, not recruiting
Woodland Memorial Hospital
Woodland, California 95695
Active, not recruiting
UCHealth University of Colorado Hospital
Aurora, Colorado 80045
Active, not recruiting
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado 80907
Active, not recruiting
UCHealth Memorial Hospital Central
Colorado Springs, Colorado 80909
Active, not recruiting
Memorial Hospital North
Colorado Springs, Colorado 80920
Active, not recruiting
Poudre Valley Hospital
Fort Collins, Colorado 80524
Active, not recruiting
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado 80528
Active, not recruiting
UCHealth Greeley Hospital
Greeley, Colorado 80631
Active, not recruiting
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado 80129
Active, not recruiting
Medical Center of the Rockies
Loveland, Colorado 80538
Active, not recruiting
CTCA at Southeastern Regional Medical Center
Newnan, Georgia 30265
Active, not recruiting
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii 96819
Active, not recruiting
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
Active, not recruiting
Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
Active, not recruiting
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
Active, not recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
Active, not recruiting
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
Active, not recruiting
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
Active, not recruiting
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho 83687
Active, not recruiting
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83687
Active, not recruiting
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
Active, not recruiting
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho 83864
Active, not recruiting
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho 83301
Active, not recruiting
Rush - Copley Medical Center
Aurora, Illinois 60504
Active, not recruiting
Advocate Good Shepherd Hospital
Barrington, Illinois 60010
Active, not recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
Active, not recruiting
Illinois CancerCare-Canton
Canton, Illinois 61520
Active, not recruiting
Illinois CancerCare-Carthage
Carthage, Illinois 62321
Active, not recruiting
Centralia Oncology Clinic
Centralia, Illinois 62801
Active, not recruiting
University of Illinois
Chicago, Illinois 60612
Active, not recruiting
Advocate Illinois Masonic Medical Center
Chicago, Illinois 60657
Active, not recruiting
AMG Crystal Lake - Oncology
Crystal Lake, Illinois 60014
Active, not recruiting
Carle at The Riverfront
Danville, Illinois 61832
Active, not recruiting
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Active, not recruiting
Decatur Memorial Hospital
Decatur, Illinois 62526
Active, not recruiting
Illinois CancerCare-Dixon
Dixon, Illinois 61021
Active, not recruiting
Advocate Good Samaritan Hospital
Downers Grove, Illinois 60515
Active, not recruiting
Carle Physician Group-Effingham
Effingham, Illinois 62401
Active, not recruiting
Crossroads Cancer Center
Effingham, Illinois 62401
Active, not recruiting
Advocate Sherman Hospital
Elgin, Illinois 60123
Active, not recruiting
Illinois CancerCare-Eureka
Eureka, Illinois 61530
Active, not recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
Active, not recruiting
Advocate South Suburban Hospital
Hazel Crest, Illinois 60429
Active, not recruiting
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
Active, not recruiting
AMG Libertyville - Oncology
Libertyville, Illinois 60048
Active, not recruiting
Condell Memorial Hospital
Libertyville, Illinois 60048
Active, not recruiting
Illinois CancerCare-Macomb
Macomb, Illinois 61455
Active, not recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
Active, not recruiting
Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
Active, not recruiting
Advocate Christ Medical Center
Oak Lawn, Illinois 60453-2699
Active, not recruiting
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
Active, not recruiting
Advocate Lutheran General Hospital
Park Ridge, Illinois 60068
Active, not recruiting
Illinois CancerCare-Pekin
Pekin, Illinois 61554
Active, not recruiting
Illinois CancerCare-Peoria
Peoria, Illinois 61615
Active, not recruiting
Illinois CancerCare-Peru
Peru, Illinois 61354
Active, not recruiting
Illinois CancerCare-Princeton
Princeton, Illinois 61356
Active, not recruiting
Southern Illinois University School of Medicine
Springfield, Illinois 62702
Active, not recruiting
Springfield Clinic
Springfield, Illinois 62702
Active, not recruiting
Springfield Memorial Hospital
Springfield, Illinois 62781
Active, not recruiting
Carle Cancer Center
Urbana, Illinois 61801
Active, not recruiting
Illinois CancerCare - Washington
Washington, Illinois 61571
Active, not recruiting
Rush-Copley Healthcare Center
Yorkville, Illinois 60560
Active, not recruiting
Northwest Cancer Center - Main Campus
Crown Point, Indiana 46307
Active, not recruiting
Northwest Oncology LLC
Dyer, Indiana 46311
Active, not recruiting
Northwest Cancer Center - Hobart
Hobart, Indiana 46342
Active, not recruiting
Saint Mary Medical Center
Hobart, Indiana 46342
Active, not recruiting
Franciscan Health Indianapolis
Indianapolis, Indiana 46237
Active, not recruiting
Saint Catherine Hospital
Indianapolis, Indiana 46312
Active, not recruiting
Franciscan Saint Elizabeth Health - Lafayette East
Lafayette, Indiana 47905
Active, not recruiting
Woodland Cancer Care Center
Michigan City, Indiana 46360
Active, not recruiting
Franciscan Health Mooresville
Mooresville, Indiana 46158
Active, not recruiting
The Community Hospital
Munster, Indiana 46321
Active, not recruiting
Women's Diagnostic Center - Munster
Munster, Indiana 46321
Active, not recruiting
Northwest Cancer Center - Valparaiso
Valparaiso, Indiana 46383
Active, not recruiting
Mary Greeley Medical Center
Ames, Iowa 50010
Active, not recruiting
McFarland Clinic - Ames
Ames, Iowa 50010
Active, not recruiting
McFarland Clinic - Boone
Boone, Iowa 50036
Active, not recruiting
Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
Active, not recruiting
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa 50501
Active, not recruiting
McFarland Clinic - Jefferson
Jefferson, Iowa 50129
Active, not recruiting
McFarland Clinic - Marshalltown
Marshalltown, Iowa 50158
Active, not recruiting
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana 70805
Active, not recruiting
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana 70808
Active, not recruiting
Ochsner Hematology Oncology North Shore - Covington (West Region)
Covington, Louisiana 70433
Active, not recruiting
Ochsner Medical Center Jefferson
New Orleans, Louisiana 70121
Active, not recruiting
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan 48106
Active, not recruiting
Bronson Battle Creek
Battle Creek, Michigan 49017
Active, not recruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
Active, not recruiting
Trinity Health Medical Center - Brighton
Brighton, Michigan 48114
Active, not recruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
Active, not recruiting
Trinity Health Medical Center - Canton
Canton, Michigan 48188
Active, not recruiting
Chelsea Hospital
Chelsea, Michigan 48118
Active, not recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
Active, not recruiting
Henry Ford Hospital
Detroit, Michigan 48202
Active, not recruiting
Henry Ford Health Saint John Hospital
Detroit, Michigan 48236
Active, not recruiting
Henry Ford River District Hospital
East China Township, Michigan 48054
Active, not recruiting
Cancer Hematology Centers - Flint
Flint, Michigan 48503
Active, not recruiting
Genesee Hematology Oncology PC
Flint, Michigan 48503
Active, not recruiting
Genesys Hurley Cancer Institute
Flint, Michigan 48503
Active, not recruiting
Hurley Medical Center
Flint, Michigan 48503
Active, not recruiting
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan 49503
Active, not recruiting
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan 49503
Active, not recruiting
Henry Ford Saint John Hospital - Academic
Grosse Pointe Woods, Michigan 48236
Active, not recruiting
Henry Ford Saint John Hospital - Van Elslander
Grosse Pointe Woods, Michigan 48236
Active, not recruiting
Bronson Methodist Hospital
Kalamazoo, Michigan 49007
Active, not recruiting
West Michigan Cancer Center
Kalamazoo, Michigan 49007
Active, not recruiting
Ascension Borgess Cancer Center
Kalamazoo, Michigan 49009
Active, not recruiting
University of Michigan Health - Sparrow Lansing
Lansing, Michigan 48912
Active, not recruiting
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
Active, not recruiting
Henry Ford Saint John Hospital - Macomb Medical
Macomb, Michigan 48044
Active, not recruiting
Trinity Health Muskegon Hospital
Muskegon, Michigan 49444
Active, not recruiting
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan 49120
Active, not recruiting
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan 49444
Active, not recruiting
Henry Ford Health Providence Novi Hospital
Novi, Michigan 48374
Active, not recruiting
Henry Ford Medical Center-Columbus
Novi, Michigan 48377
Active, not recruiting
Corewell Health Reed City Hospital
Reed City, Michigan 49677
Active, not recruiting
MyMichigan Medical Center Saginaw
Saginaw, Michigan 48601
Active, not recruiting
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan 48604
Active, not recruiting
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
Active, not recruiting
Henry Ford Health Providence Southfield Hospital
Southfield, Michigan 48075
Active, not recruiting
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, Michigan 48312
Active, not recruiting
MyMichigan Medical Center Tawas
Tawas City, Michigan 48764
Active, not recruiting
Munson Medical Center
Traverse City, Michigan 49684
Active, not recruiting
Henry Ford Health Warren Hospital
Warren, Michigan 48093
Active, not recruiting
Henry Ford Warren Hospital - GLCMS
Warren, Michigan 48093
Active, not recruiting
Macomb Hematology Oncology PC
Warren, Michigan 48093
Active, not recruiting
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan 48322
Active, not recruiting
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan 48661
Active, not recruiting
University of Michigan Health - West
Wyoming, Michigan 49519
Active, not recruiting
Huron Gastroenterology PC
Ypsilanti, Michigan 48106
Active, not recruiting
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
Active, not recruiting
Mercy Hospital
Coon Rapids, Minnesota 55433
Active, not recruiting
Essentia Health - Deer River Clinic
Deer River, Minnesota 56636
Active, not recruiting
Essentia Health Cancer Center
Duluth, Minnesota 55805
Active, not recruiting
Fairview Southdale Hospital
Edina, Minnesota 55435
Active, not recruiting
Essentia Health Hibbing Clinic
Hibbing, Minnesota 55746
Active, not recruiting
Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
Active, not recruiting
North Memorial Medical Health Center
Robbinsdale, Minnesota 55422
Active, not recruiting
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
Active, not recruiting
Regions Hospital
Saint Paul, Minnesota 55101
Active, not recruiting
United Hospital
Saint Paul, Minnesota 55102
Active, not recruiting
Essentia Health Sandstone
Sandstone, Minnesota 55072
Active, not recruiting
Essentia Health Virginia Clinic
Virginia, Minnesota 55792
Active, not recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Active, not recruiting
Community Hospital of Anaconda
Anaconda, Montana 59711
Active, not recruiting
Billings Clinic Cancer Center
Billings, Montana 59101
Active, not recruiting
Bozeman Health Deaconess Hospital
Bozeman, Montana 59715
Active, not recruiting
Benefis Sletten Cancer Institute
Great Falls, Montana 59405
Active, not recruiting
Logan Health Medical Center
Kalispell, Montana 59901
Active, not recruiting
Community Medical Center
Missoula, Montana 59804
Active, not recruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire 03756
Active, not recruiting
Hunterdon Medical Center
Flemington, New Jersey 08822
Active, not recruiting
Roswell Park Cancer Institute
Buffalo, New York 14263
Active, not recruiting
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina 28328
Active, not recruiting
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina 27534
Active, not recruiting
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina 28546
Active, not recruiting
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina 28374
Active, not recruiting
Strecker Cancer Center-Belpre
Belpre, Ohio 45714
Active, not recruiting
Miami Valley Hospital South
Centerville, Ohio 45459
Active, not recruiting
Adena Regional Medical Center
Chillicothe, Ohio 45601
Active, not recruiting
Mount Carmel East Hospital
Columbus, Ohio 43213
Active, not recruiting
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio 43214
Active, not recruiting
Riverside Methodist Hospital
Columbus, Ohio 43214
Active, not recruiting
Grant Medical Center
Columbus, Ohio 43215
Active, not recruiting
The Mark H Zangmeister Center
Columbus, Ohio 43219
Active, not recruiting
Doctors Hospital
Columbus, Ohio 43228
Active, not recruiting
Miami Valley Hospital
Dayton, Ohio 45409
Active, not recruiting
Premier Blood and Cancer Center
Dayton, Ohio 45409
Active, not recruiting
Dayton Physician LLC - Englewood
Dayton, Ohio 45415
Active, not recruiting
Miami Valley Hospital North
Dayton, Ohio 45415
Active, not recruiting
Delaware Health Center-Grady Cancer Center
Delaware, Ohio 43015
Active, not recruiting
Grady Memorial Hospital
Delaware, Ohio 43015
Active, not recruiting
Columbus Oncology and Hematology Associates
Dublin, Ohio 43016
Active, not recruiting
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
Active, not recruiting
Dayton Physicians LLC-Atrium
Franklin, Ohio 45005
Active, not recruiting
Miami Valley Cancer Care and Infusion
Greenville, Ohio 45331
Active, not recruiting
Mount Carmel Grove City Hospital
Grove City, Ohio 43123
Active, not recruiting
Kettering Medical Center
Kettering, Ohio 45429
Active, not recruiting
Fairfield Medical Center
Lancaster, Ohio 43130
Active, not recruiting
OhioHealth Mansfield Hospital
Mansfield, Ohio 44903
Active, not recruiting
OhioHealth Marion General Hospital
Marion, Ohio 43302
Active, not recruiting
Memorial Hospital
Marysville, Ohio 43040
Active, not recruiting
Knox Community Hospital
Mount Vernon, Ohio 43050
Active, not recruiting
Licking Memorial Hospital
Newark, Ohio 43055
Active, not recruiting
Southern Ohio Medical Center
Portsmouth, Ohio 45662
Active, not recruiting
Springfield Regional Cancer Center
Springfield, Ohio 45504
Active, not recruiting
Springfield Regional Medical Center
Springfield, Ohio 45504
Active, not recruiting
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio 43623
Active, not recruiting
Upper Valley Medical Center
Troy, Ohio 45373
Active, not recruiting
Saint Ann's Hospital
Westerville, Ohio 43081
Active, not recruiting
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio 43701
Active, not recruiting
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma 73505
Active, not recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Active, not recruiting
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma 73120
Active, not recruiting
Clackamas Radiation Oncology Center
Clackamas, Oregon 97015
Active, not recruiting
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon 97015
Active, not recruiting
Providence Newberg Medical Center
Newberg, Oregon 97132
Active, not recruiting
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon 97914
Active, not recruiting
Providence Willamette Falls Medical Center
Oregon City, Oregon 97045
Active, not recruiting
Providence Portland Medical Center
Portland, Oregon 97213
Active, not recruiting
Providence Saint Vincent Medical Center
Portland, Oregon 97225
Active, not recruiting
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania 18103
Active, not recruiting
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania 18017
Active, not recruiting
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania 19104
Active, not recruiting
Reading Hospital
West Reading, Pennsylvania 19611
Active, not recruiting
Rhode Island Hospital
Providence, Rhode Island 02903
Active, not recruiting
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina 29316
Active, not recruiting
Medical University of South Carolina
Charleston, South Carolina 29425
Active, not recruiting
Prisma Health Cancer Institute - Easley
Easley, South Carolina 29640
Active, not recruiting
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina 29605
Active, not recruiting
Prisma Health Cancer Institute - Faris
Greenville, South Carolina 29605
Active, not recruiting
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina 29605
Active, not recruiting
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina 29615
Active, not recruiting
Prisma Health Cancer Institute - Greer
Greer, South Carolina 29650
Active, not recruiting
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina 29672
Active, not recruiting
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
Active, not recruiting
The Don and Sybil Harrington Cancer Center
Amarillo, Texas 79106
Active, not recruiting
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas 75237
Active, not recruiting
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
Active, not recruiting
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas 76104
Active, not recruiting
M D Anderson Cancer Center
Houston, Texas 77030
Active, not recruiting
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas 75080
Active, not recruiting
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
Active, not recruiting
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont 05819
Active, not recruiting
Swedish Cancer Institute-Edmonds
Edmonds, Washington 98026
Active, not recruiting
Swedish Cancer Institute-Issaquah
Issaquah, Washington 98029
Active, not recruiting
Swedish Medical Center-First Hill
Seattle, Washington 98122
Active, not recruiting
United Hospital Center
Bridgeport, West Virginia 26330
Active, not recruiting
West Virginia University Healthcare
Morgantown, West Virginia 26506
Active, not recruiting
ThedaCare Regional Cancer Center
Appleton, Wisconsin 54911
Active, not recruiting
Duluth Clinic Ashland
Ashland, Wisconsin 54806
Active, not recruiting
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin 53105
Active, not recruiting
Aurora Saint Luke's South Shore
Cudahy, Wisconsin 53110
Active, not recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
Active, not recruiting
Aurora Health Care Germantown Health Center
Germantown, Wisconsin 53022
Active, not recruiting
Aurora Cancer Care-Grafton
Grafton, Wisconsin 53024
Active, not recruiting
Aurora BayCare Medical Center
Green Bay, Wisconsin 54311
Active, not recruiting
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin 53142
Active, not recruiting
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin 54143
Active, not recruiting
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
Active, not recruiting
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin 53209
Active, not recruiting
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin 53215
Active, not recruiting
Aurora Sinai Medical Center
Milwaukee, Wisconsin 53233
Active, not recruiting
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin 54548
Active, not recruiting
ProHealth D N Greenwald Center
Mukwonago, Wisconsin 53149
Active, not recruiting
Cancer Center of Western Wisconsin
New Richmond, Wisconsin 54017
Active, not recruiting
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066
Active, not recruiting
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin 54904
Active, not recruiting
Aurora Cancer Care-Racine
Racine, Wisconsin 53406
Active, not recruiting
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
Active, not recruiting
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin 53081
Active, not recruiting
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
Active, not recruiting
Aurora Medical Center in Summit
Summit, Wisconsin 53066
Active, not recruiting
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin 54241
Active, not recruiting
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin 53188
Active, not recruiting
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin 53226
Active, not recruiting
Aurora West Allis Medical Center
West Allis, Wisconsin 53227
Active, not recruiting
Marshfield Medical Center - Weston
Weston, Wisconsin 54476
Active, not recruiting
Puerto Rico
Puerto Rico Hematology Oncology Group
Bayamon 00961
Active, not recruiting
Centro Comprensivo de Cancer de UPR
San Juan 00927
Active, not recruiting
PROncology
San Juan 00927
Active, not recruiting
San Juan City Hospital
San Juan 00936
Active, not recruiting

Inclusion Criteria

Inclusion Criteria:

* 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)
* Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to registration)
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x institutional ULN (within 28 days prior to registration)
* If liver metastases are present, then it is acceptable for AST level =< 5.0 x ULN, and/or an ALT level =< 5.0 x ULN (within 28 days prior to registration)
* Participants must have serum creatinine =< the IULN OR measured OR calculated creatinine clearance >= 50 mL/min using the Cockroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration
* Participants must be able to swallow and retain pills
* Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2 or better
* Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System
* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.

* Note: As a part of the OPEN registration process, the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

Exclusion Criteria

Exclusion Criteria:

* 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.

* Uncontrolled blood pressure and hypertension is defined as systolic blood pressure (SBP) > 170 mmHg or diastolic blood pressure (DBP) > 100 mmHg within 28 days prior to registration. Participants are permitted to be receiving multiple anti-hypertensive medications (unless otherwise indicated in the study). All blood pressure measurements within the 28 days prior to registration must be SBP =< 170 and DBP =< 100. An exception can be made by a healthcare provider for a participant with a single blood pressure elevation who upon rechecking has a normal blood pressure
* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen or requires concurrent therapy
* Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion and vasectomy with testing showing no sperm in the semen
* Participants must not be planning treatment with other systemic anti-cancer agents (e.g., chemotherapy, hormonal therapy, immunotherapy) or other treatments not part of protocol-specified anti-cancer therapy including concurrent investigational agents of any type

NCT ID

NCT05308446

Date Trial Added

2022-04-04

Updated Date

2024-12-27