Program Status
Active, not recruitingPhase
Phase 2Prior Immunotherapy Allowed
NoCRC-directed Trial
YesDrugs
cetuximab, encorafenib, Nivolumab, Braftovi, Erbitux, OpdivoTags
MSS/ MMRpComments
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.
Helpful Links
Triplet Regimen for Microsatellite Stable SWOG S2107: Randomized phase II trial of encorafenib and cetuximab with or without nivolumab for patients with previously treated Randomized phase II trial of encorafenib and cetuximab with or without nivolumab for patients with previously treatedLocation | 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