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

April 18, 2024 updated by: National Cancer Institute (NCI)

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To compare progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 in patients with microsatellite stable (MSS), BRAF^V600E metastatic and/or unresectable colorectal cancer (CRC) randomized to treatment with nivolumab + encorafenib + cetuximab compared to encorafenib + cetuximab.

SECONDARY OBJECTIVES:

I. To compare overall response rate (ORR), including confirmed and unconfirmed, complete and partial response, according to RECIST 1.1 criteria between the two arms.

II. To compare overall survival (OS) between the two arms. III. To compare duration of response between the two arms. IV. To compare safety and tolerability between the two arms. V. To assess immune-related PFS using modified response criteria adapted for immunotherapy (irRC-PFS) in patients treated with nivolumab + encorafenib + cetuximab.

BANKING OBJECTIVE:

I. To bank tissue and blood specimens for future correlative studies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive encorafenib orally (PO) once daily (QD) on days 1-28, cetuximab intravenously (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: Patients 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.

After completion of study treatment, patients are followed until death or 3 years after registration, whichever occurs first.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Recruiting
        • Centro Comprensivo de Cancer de UPR
        • Principal Investigator:
          • Luis J. Santos Reyes
        • Contact:
      • San Juan, Puerto Rico, 00936
        • Recruiting
        • San Juan City Hospital
        • Principal Investigator:
          • Luis J. Santos Reyes
        • Contact:
          • Site Public Contact
          • Phone Number: 787-763-1296
      • San Juan, Puerto Rico, 00927
        • Recruiting
        • PROncology
        • Principal Investigator:
          • Luis J. Santos Reyes
        • Contact:
  • United States
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • Recruiting
        • CTCA at Western Regional Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 623-207-3000
        • Principal Investigator:
          • Sagun Shrestha
    • California
      • Dublin, California, United States, 94568
        • Recruiting
        • Kaiser Permanente Dublin
        • Principal Investigator:
          • Tatjana Kolevska
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
      • Fremont, California, United States, 94538
        • Recruiting
        • Kaiser Permanente-Fremont
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • Fresno, California, United States, 93720
        • Recruiting
        • Kaiser Permanente-Fresno
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • Modesto, California, United States, 95356
        • Recruiting
        • Kaiser Permanente-Modesto
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • Oakland, California, United States, 94611
        • Recruiting
        • Kaiser Permanente-Oakland
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Jennifer B. Valerin
      • Roseville, California, United States, 95661
        • Recruiting
        • Kaiser Permanente-Roseville
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • Sacramento, California, United States, 95814
        • Recruiting
        • Kaiser Permanente Downtown Commons
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • Sacramento, California, United States, 95823
        • Recruiting
        • Kaiser Permanente-South Sacramento
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • San Francisco, California, United States, 94115
        • Recruiting
        • Kaiser Permanente-San Francisco
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • San Jose, California, United States, 95119
        • Recruiting
        • Kaiser Permanente-Santa Teresa-San Jose
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • San Leandro, California, United States, 94577
        • Recruiting
        • Kaiser Permanente San Leandro
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • Santa Clara, California, United States, 95051
        • Recruiting
        • Kaiser Permanente Medical Center - Santa Clara
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Kaiser Permanente-Santa Rosa
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • South San Francisco, California, United States, 94080
        • Recruiting
        • Kaiser Permanente-South San Francisco
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • Vallejo, California, United States, 94589
        • Recruiting
        • Kaiser Permanente-Vallejo
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
      • Walnut Creek, California, United States, 94596
        • Recruiting
        • Kaiser Permanente-Walnut Creek
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Tatjana Kolevska
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • UCHealth University of Colorado Hospital
        • Principal Investigator:
          • Christopher H. Lieu
        • Contact:
          • Site Public Contact
          • Phone Number: 720-848-0650
      • Colorado Springs, Colorado, United States, 80909
        • Recruiting
        • UCHealth Memorial Hospital Central
        • Principal Investigator:
          • Christopher H. Lieu
        • Contact:
          • Site Public Contact
          • Phone Number: 719-365-2406
      • Colorado Springs, Colorado, United States, 80920
        • Recruiting
        • Memorial Hospital North
        • Principal Investigator:
          • Christopher H. Lieu
        • Contact:
          • Site Public Contact
          • Phone Number: 719-364-6700
      • Colorado Springs, Colorado, United States, 80907
      • Fort Collins, Colorado, United States, 80524
        • Recruiting
        • Poudre Valley Hospital
        • Principal Investigator:
          • Christopher H. Lieu
        • Contact:
          • Site Public Contact
          • Phone Number: 970-297-6150
      • Fort Collins, Colorado, United States, 80528
        • Recruiting
        • Cancer Care and Hematology-Fort Collins
        • Principal Investigator:
          • Christopher H. Lieu
        • Contact:
      • Greeley, Colorado, United States, 80631
        • Recruiting
        • UCHealth Greeley Hospital
        • Principal Investigator:
          • Christopher H. Lieu
        • Contact:
      • Highlands Ranch, Colorado, United States, 80129
        • Recruiting
        • UCHealth Highlands Ranch Hospital
        • Principal Investigator:
          • Christopher H. Lieu
        • Contact:
          • Site Public Contact
          • Phone Number: 720-848-0650
      • Loveland, Colorado, United States, 80538
        • Recruiting
        • Medical Center of the Rockies
        • Principal Investigator:
          • Christopher H. Lieu
        • Contact:
          • Site Public Contact
          • Phone Number: 970-203-7083
    • Georgia
      • Newnan, Georgia, United States, 30265
        • Recruiting
        • CTCA at Southeastern Regional Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 770-400-6629
        • Principal Investigator:
          • Shahin Chowdhury
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • Recruiting
        • Kaiser Permanente Moanalua Medical Center
        • Principal Investigator:
          • Tatjana Kolevska
        • Contact:
    • Idaho
      • Boise, Idaho, United States, 83712
        • Recruiting
        • Saint Luke's Cancer Institute - Boise
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Boise, Idaho, United States, 83706
        • Suspended
        • Saint Alphonsus Cancer Care Center-Boise
      • Caldwell, Idaho, United States, 83605
        • Suspended
        • Saint Alphonsus Cancer Care Center-Caldwell
      • Coeur d'Alene, Idaho, United States, 83814
        • Recruiting
        • Kootenai Health - Coeur d'Alene
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Fruitland, Idaho, United States, 83619
        • Recruiting
        • Saint Luke's Cancer Institute - Fruitland
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Saint Luke's Cancer Institute - Meridian
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Nampa, Idaho, United States, 83686
        • Recruiting
        • Saint Luke's Cancer Institute - Nampa
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Nampa, Idaho, United States, 83687
        • Suspended
        • Saint Alphonsus Cancer Care Center-Nampa
      • Post Falls, Idaho, United States, 83854
        • Recruiting
        • Kootenai Clinic Cancer Services - Post Falls
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Sandpoint, Idaho, United States, 83864
        • Recruiting
        • Kootenai Cancer Clinic
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Twin Falls, Idaho, United States, 83301
        • Recruiting
        • Saint Luke's Cancer Institute - Twin Falls
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Recruiting
        • Rush - Copley Medical Center
        • Contact:
        • Principal Investigator:
          • Tanmay Sahai
      • Barrington, Illinois, United States, 60010
        • Recruiting
        • Advocate Good Shepherd Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-842-4847
        • Principal Investigator:
          • Edward S. James
      • Bloomington, Illinois, United States, 61704
        • Recruiting
        • Illinois CancerCare-Bloomington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Canton, Illinois, United States, 61520
        • Recruiting
        • Illinois CancerCare-Canton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Carthage, Illinois, United States, 62321
        • Recruiting
        • Illinois CancerCare-Carthage
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Centralia, Illinois, United States, 62801
        • Recruiting
        • Centralia Oncology Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois
        • Contact:
          • Site Public Contact
          • Phone Number: 312-355-3046
        • Principal Investigator:
          • Shikha Jain
      • Chicago, Illinois, United States, 60657
        • Recruiting
        • Advocate Illinois Masonic Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 773-296-5360
        • Principal Investigator:
          • Edward S. James
      • Crystal Lake, Illinois, United States, 60014
        • Recruiting
        • AMG Crystal Lake - Oncology
        • Contact:
        • Principal Investigator:
          • Edward S. James
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Contact:
        • Principal Investigator:
          • Tanmay Sahai
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Cancer Care Specialists of Illinois - Decatur
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Decatur Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Dixon, Illinois, United States, 61021
        • Recruiting
        • Illinois CancerCare-Dixon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 815-285-7800
      • Downers Grove, Illinois, United States, 60515
        • Recruiting
        • Advocate Good Samaritan Hospital
        • Contact:
        • Principal Investigator:
          • Edward S. James
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Carle Physician Group-Effingham
        • Contact:
        • Principal Investigator:
          • Tanmay Sahai
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Crossroads Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Elgin, Illinois, United States, 60123
        • Recruiting
        • Advocate Sherman Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-429-2907
        • Principal Investigator:
          • Edward S. James
      • Eureka, Illinois, United States, 61530
        • Recruiting
        • Illinois CancerCare-Eureka
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Galesburg, Illinois, United States, 61401
        • Recruiting
        • Illinois CancerCare-Galesburg
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Hazel Crest, Illinois, United States, 60429
        • Recruiting
        • Advocate South Suburban Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 708-799-9995
        • Principal Investigator:
          • Edward S. James
      • Kewanee, Illinois, United States, 61443
        • Recruiting
        • Illinois CancerCare-Kewanee Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Libertyville, Illinois, United States, 60048
        • Recruiting
        • AMG Libertyville - Oncology
        • Contact:
        • Principal Investigator:
          • Edward S. James
      • Libertyville, Illinois, United States, 60048
        • Recruiting
        • Condell Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Edward S. James
      • Macomb, Illinois, United States, 61455
        • Recruiting
        • Illinois CancerCare-Macomb
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Mattoon, Illinois, United States, 61938
        • Recruiting
        • Carle Physician Group-Mattoon/Charleston
        • Contact:
        • Principal Investigator:
          • Tanmay Sahai
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Cancer Care Center of O'Fallon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Oak Lawn, Illinois, United States, 60453-2699
        • Recruiting
        • Advocate Christ Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-323-8622
        • Principal Investigator:
          • Edward S. James
      • Ottawa, Illinois, United States, 61350
        • Recruiting
        • Illinois CancerCare-Ottawa Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Park Ridge, Illinois, United States, 60068
        • Recruiting
        • Advocate Lutheran General Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-384-3621
        • Principal Investigator:
          • Edward S. James
      • Pekin, Illinois, United States, 61554
        • Recruiting
        • Illinois CancerCare-Pekin
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peoria, Illinois, United States, 61615
        • Recruiting
        • Illinois CancerCare-Peoria
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peru, Illinois, United States, 61354
        • Recruiting
        • Illinois CancerCare-Peru
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Princeton, Illinois, United States, 61356
        • Recruiting
        • Illinois CancerCare-Princeton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University School of Medicine
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 217-545-7929
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Springfield Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 800-444-7541
      • Springfield, Illinois, United States, 62781
        • Recruiting
        • Memorial Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Contact:
        • Principal Investigator:
          • Tanmay Sahai
      • Washington, Illinois, United States, 61571
        • Recruiting
        • Illinois CancerCare - Washington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Yorkville, Illinois, United States, 60560
        • Recruiting
        • Rush-Copley Healthcare Center
        • Contact:
        • Principal Investigator:
          • Tanmay Sahai
    • Indiana
      • Crown Point, Indiana, United States, 46307
        • Recruiting
        • Northwest Cancer Center - Main Campus
        • Contact:
          • Site Public Contact
          • Phone Number: 219-310-2550
        • Principal Investigator:
          • Tanmay Sahai
      • Dyer, Indiana, United States, 46311
        • Recruiting
        • Northwest Oncology LLC
        • Contact:
          • Site Public Contact
          • Phone Number: 219-924-8178
        • Principal Investigator:
          • Tanmay Sahai
      • Hobart, Indiana, United States, 46342
        • Recruiting
        • Northwest Cancer Center - Hobart
        • Contact:
          • Site Public Contact
          • Phone Number: 219-947-1795
        • Principal Investigator:
          • Tanmay Sahai
      • Hobart, Indiana, United States, 46342
        • Recruiting
        • Saint Mary Medical Center
        • Principal Investigator:
          • Tanmay Sahai
        • Contact:
      • Indianapolis, Indiana, United States, 46237
        • Recruiting
        • Franciscan Health Indianapolis
        • Contact:
          • Site Public Contact
          • Phone Number: 317-528-7060
        • Principal Investigator:
          • Meghana Raghavendra
      • Indianapolis, Indiana, United States, 46312
        • Recruiting
        • Saint Catherine Hospital
        • Contact:
        • Principal Investigator:
          • Tanmay Sahai
      • Lafayette, Indiana, United States, 47905
        • Recruiting
        • Franciscan Saint Elizabeth Health - Lafayette East
        • Contact:
        • Principal Investigator:
          • Meghana Raghavendra
      • Michigan City, Indiana, United States, 46360
        • Recruiting
        • Woodland Cancer Care Center
        • Principal Investigator:
          • Meghana Raghavendra
        • Contact:
      • Mooresville, Indiana, United States, 46158
        • Recruiting
        • Franciscan Health Mooresville
        • Contact:
          • Site Public Contact
          • Phone Number: 317-834-3603
        • Principal Investigator:
          • Meghana Raghavendra
      • Munster, Indiana, United States, 46321
        • Recruiting
        • The Community Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 219-836-3349
        • Principal Investigator:
          • Tanmay Sahai
      • Munster, Indiana, United States, 46321
        • Recruiting
        • Women's Diagnostic Center - Munster
        • Contact:
        • Principal Investigator:
          • Tanmay Sahai
      • Valparaiso, Indiana, United States, 46383
        • Recruiting
        • Northwest Cancer Center - Valparaiso
        • Principal Investigator:
          • Tanmay Sahai
        • Contact:
    • Iowa
      • Ames, Iowa, United States, 50010
        • Recruiting
        • Mary Greeley Medical Center
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Ames, Iowa, United States, 50010
        • Recruiting
        • McFarland Clinic - Ames
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
      • Boone, Iowa, United States, 50036
        • Recruiting
        • McFarland Clinic - Boone
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Mercy Medical Center - Des Moines
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Fort Dodge, Iowa, United States, 50501
        • Recruiting
        • McFarland Clinic - Trinity Cancer Center
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Jefferson, Iowa, United States, 50129
        • Recruiting
        • McFarland Clinic - Jefferson
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Marshalltown, Iowa, United States, 50158
        • Recruiting
        • McFarland Clinic - Marshalltown
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70805
        • Recruiting
        • LSU Health Baton Rouge-North Clinic
        • Contact:
        • Principal Investigator:
          • Marshall P. Stagg
      • Baton Rouge, Louisiana, United States, 70809
        • Recruiting
        • Our Lady of the Lake Physicians Group - Medical Oncology
        • Contact:
        • Principal Investigator:
          • Marshall P. Stagg
      • Covington, Louisiana, United States, 70433
        • Recruiting
        • Ochsner Hematology Oncology North Shore - Covington (West Region)
        • Principal Investigator:
          • Lingling Du
        • Contact:
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Medical Center Jefferson
        • Principal Investigator:
          • Lingling Du
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
      • Battle Creek, Michigan, United States, 49017
        • Recruiting
        • Bronson Battle Creek
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Brighton, Michigan, United States, 48114
      • Brighton, Michigan, United States, 48114
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Canton, Michigan, United States, 48188
      • Canton, Michigan, United States, 48188
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Chelsea, Michigan, United States, 48118
      • Chelsea, Michigan, United States, 48118
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Detroit, Michigan, United States, 48236
        • Recruiting
        • Ascension Saint John Hospital
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
        • Principal Investigator:
          • Gazala N. Khan
      • East China Township, Michigan, United States, 48054
        • Recruiting
        • Great Lakes Cancer Management Specialists-Doctors Park
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesee Cancer and Blood Disease Treatment Center
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesee Hematology Oncology PC
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesys Hurley Cancer Institute
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Hurley Medical Center
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Spectrum Health at Butterworth Campus
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Trinity Health Grand Rapids Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Recruiting
        • Academic Hematology Oncology Specialists
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Recruiting
        • Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • Bronson Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • West Michigan Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49009
        • Recruiting
        • Ascension Borgess Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • University of Michigan Health - Sparrow Lansing
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Livonia, Michigan, United States, 48154
        • Recruiting
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
      • Macomb, Michigan, United States, 48044
        • Recruiting
        • Great Lakes Cancer Management Specialists-Macomb Medical Campus
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Muskegon, Michigan, United States, 49444
        • Recruiting
        • Trinity Health Muskegon Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Norton Shores, Michigan, United States, 49444
        • Recruiting
        • Cancer and Hematology Centers of Western Michigan - Norton Shores
        • Principal Investigator:
          • Kathleen J. Yost
        • Contact:
      • Novi, Michigan, United States, 48374
        • Recruiting
        • Ascension Providence Hospitals - Novi
        • Contact:
        • Principal Investigator:
          • Susan E. Lyons
      • Reed City, Michigan, United States, 49677
        • Recruiting
        • Corewell Health Reed City Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Saint Joseph, Michigan, United States, 49085
        • Recruiting
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Southfield, Michigan, United States, 48075
        • Recruiting
        • Ascension Providence Hospitals - Southfield
        • Contact:
        • Principal Investigator:
          • Susan E. Lyons
      • Sterling Heights, Michigan, United States, 48312
        • Recruiting
        • Bhadresh Nayak MD PC-Sterling Heights
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Traverse City, Michigan, United States, 49684
        • Recruiting
        • Munson Medical Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Warren, Michigan, United States, 48093
        • Recruiting
        • Great Lakes Cancer Management Specialists-Macomb Professional Building
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Warren, Michigan, United States, 48093
        • Recruiting
        • Macomb Hematology Oncology PC
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Warren, Michigan, United States, 48093
        • Recruiting
        • Saint John Macomb-Oakland Hospital
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Wyoming, Michigan, United States, 49519
        • Recruiting
        • University of Michigan Health - West
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Ypsilanti, Michigan, United States, 48106
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contact:
        • Principal Investigator:
          • Christopher M. Reynolds
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Mercy Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Deer River, Minnesota, United States, 56636
        • Recruiting
        • Essentia Health - Deer River Clinic
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • Essentia Health Cancer Center
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • Fairview Southdale Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Hibbing, Minnesota, United States, 55746
        • Recruiting
        • Essentia Health Hibbing Clinic
        • Principal Investigator:
          • Bret E. Friday
        • Contact:
          • Site Public Contact
          • Phone Number: 218-786-3308
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Abbott-Northwestern Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Robbinsdale, Minnesota, United States, 55422
        • Recruiting
        • North Memorial Medical Health Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Park Nicollet Clinic - Saint Louis Park
        • Contact:
        • Principal Investigator:
          • David M. King
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Regions Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Saint Paul, Minnesota, United States, 55102
        • Recruiting
        • United Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Sandstone, Minnesota, United States, 55072
        • Recruiting
        • Essentia Health Sandstone
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Virginia, Minnesota, United States, 55792
        • Recruiting
        • Essentia Health Virginia Clinic
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • Saint Francis Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 573-334-2230
          • Email: sfmc@sfmc.net
    • Montana
      • Anaconda, Montana, United States, 59711
        • Recruiting
        • Community Hospital of Anaconda
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Billings, Montana, United States, 59101
        • Recruiting
        • Billings Clinic Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Bozeman, Montana, United States, 59715
        • Recruiting
        • Bozeman Deaconess Hospital
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Benefis Healthcare- Sletten Cancer Institute
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Kalispell, Montana, United States, 59901
        • Recruiting
        • Kalispell Regional Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Missoula, Montana, United States, 59804
        • Recruiting
        • Community Medical Hospital
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
        • Contact:
        • Principal Investigator:
          • Gabriel A. Brooks
    • New Jersey
      • Flemington, New Jersey, United States, 08822
        • Suspended
        • Hunterdon Medical Center
    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute
        • Contact:
        • Principal Investigator:
          • Deepak Vadehra
    • North Carolina
      • Clinton, North Carolina, United States, 28328
        • Recruiting
        • Southeastern Medical Oncology Center-Clinton
        • Contact:
        • Principal Investigator:
          • Samer S. Kasbari
      • Goldsboro, North Carolina, United States, 27534
        • Recruiting
        • Southeastern Medical Oncology Center-Goldsboro
        • Contact:
        • Principal Investigator:
          • Samer S. Kasbari
      • Jacksonville, North Carolina, United States, 28546
        • Recruiting
        • Southeastern Medical Oncology Center-Jacksonville
        • Principal Investigator:
          • Samer S. Kasbari
        • Contact:
      • Pinehurst, North Carolina, United States, 28374
        • Recruiting
        • FirstHealth of the Carolinas-Moore Regional Hospital
        • Contact:
        • Principal Investigator:
          • Charles S. Kuzma
    • Ohio
      • Belpre, Ohio, United States, 45714
        • Recruiting
        • Strecker Cancer Center-Belpre
        • Contact:
        • Principal Investigator:
          • Timothy D. Moore
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Miami Valley Hospital South
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Chillicothe, Ohio, United States, 45601
        • Recruiting
        • Adena Regional Medical Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Columbus, Ohio, United States, 43213
        • Recruiting
        • Mount Carmel East Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Columbus, Ohio, United States, 43219
        • Recruiting
        • The Mark H Zangmeister Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Columbus, Ohio, United States, 43214
        • Suspended
        • Riverside Methodist Hospital
      • Columbus, Ohio, United States, 43215
        • Suspended
        • Grant Medical Center
      • Columbus, Ohio, United States, 43228
        • Suspended
        • Doctors Hospital
      • Columbus, Ohio, United States, 43214
        • Suspended
        • Columbus Oncology and Hematology Associates Inc
      • Dayton, Ohio, United States, 45409
        • Recruiting
        • Miami Valley Hospital
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Dayton, Ohio, United States, 45415
        • Recruiting
        • Dayton Physician LLC-Miami Valley Hospital North
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Dayton, Ohio, United States, 45415
        • Recruiting
        • Miami Valley Hospital North
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Dayton, Ohio, United States, 45409
        • Recruiting
        • Dayton Blood and Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 937-276-8320
        • Principal Investigator:
          • Tarek M. Sabagh
      • Delaware, Ohio, United States, 43015
        • Suspended
        • Grady Memorial Hospital
      • Delaware, Ohio, United States, 43015
        • Suspended
        • Delaware Health Center-Grady Cancer Center
      • Dublin, Ohio, United States, 43016
        • Suspended
        • Columbus Oncology and Hematology Associates
      • Franklin, Ohio, United States, 45005-1066
        • Recruiting
        • Atrium Medical Center-Middletown Regional Hospital
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Franklin, Ohio, United States, 45005
        • Recruiting
        • Dayton Physicians LLC-Atrium
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Greenville, Ohio, United States, 45331
        • Recruiting
        • Miami Valley Cancer Care and Infusion
        • Principal Investigator:
          • Tarek M. Sabagh
        • Contact:
          • Site Public Contact
          • Phone Number: 937-569-7515
      • Grove City, Ohio, United States, 43123
        • Recruiting
        • Mount Carmel Grove City Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Kettering, Ohio, United States, 45429
        • Recruiting
        • Kettering Medical Center
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Lancaster, Ohio, United States, 43130
        • Recruiting
        • Fairfield Medical Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Mansfield, Ohio, United States, 44903
        • Suspended
        • OhioHealth Mansfield Hospital
      • Marion, Ohio, United States, 43302
        • Suspended
        • OhioHealth Marion General Hospital
      • Marysville, Ohio, United States, 43040
        • Recruiting
        • Memorial Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Mount Vernon, Ohio, United States, 43050
        • Recruiting
        • Knox Community Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Newark, Ohio, United States, 43055
        • Recruiting
        • Licking Memorial Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Portsmouth, Ohio, United States, 45662
        • Recruiting
        • Southern Ohio Medical Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Springfield, Ohio, United States, 45504
        • Recruiting
        • Springfield Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Timothy D. Moore
      • Springfield, Ohio, United States, 45505
        • Recruiting
        • Springfield Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Timothy D. Moore
      • Toledo, Ohio, United States, 43623
        • Recruiting
        • Toledo Clinic Cancer Centers-Toledo
        • Principal Investigator:
          • Rex B. Mowat
        • Contact:
          • Site Public Contact
          • Phone Number: 800-444-3561
      • Troy, Ohio, United States, 45373
        • Recruiting
        • Upper Valley Medical Center
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Westerville, Ohio, United States, 43081
        • Recruiting
        • Saint Ann's Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Zanesville, Ohio, United States, 43701
        • Recruiting
        • Genesis Healthcare System Cancer Care Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
    • Oklahoma
      • Lawton, Oklahoma, United States, 73505
        • Recruiting
        • Cancer Centers of Southwest Oklahoma Research
        • Contact:
          • Site Public Contact
          • Phone Number: 877-231-4440
        • Principal Investigator:
          • Hassan Hatoum
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Hassan Hatoum
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Mercy Hospital Oklahoma City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 405-752-3402
    • Oregon
      • Clackamas, Oregon, United States, 97015
        • Recruiting
        • Providence Cancer Institute Clackamas Clinic
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Clackamas, Oregon, United States, 97015
        • Recruiting
        • Clackamas Radiation Oncology Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Newberg, Oregon, United States, 97132
        • Recruiting
        • Providence Newberg Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Ontario, Oregon, United States, 97914
        • Suspended
        • Saint Alphonsus Medical Center-Ontario
      • Oregon City, Oregon, United States, 97045
        • Recruiting
        • Providence Willamette Falls Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Saint Vincent Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • Lehigh Valley Hospital-Cedar Crest
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Bethlehem, Pennsylvania, United States, 18017
        • Recruiting
        • Lehigh Valley Hospital - Muhlenberg
        • Principal Investigator:
          • Christopher M. Reynolds
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania/Abramson Cancer Center
        • Principal Investigator:
          • Thomas B. Karasic
        • Contact:
          • Site Public Contact
          • Phone Number: 800-474-9892
      • West Reading, Pennsylvania, United States, 19611
        • Recruiting
        • Reading Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 610-988-9323
        • Principal Investigator:
          • Terrence P. Cescon
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital
        • Principal Investigator:
          • Rimini Breakstone
        • Contact:
          • Site Public Contact
          • Phone Number: 401-444-1488
    • South Carolina
      • Boiling Springs, South Carolina, United States, 29316
        • Recruiting
        • Prisma Health Cancer Institute - Spartanburg
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
        • Principal Investigator:
          • Ki Y. Chung
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Toros Dincman
      • Easley, South Carolina, United States, 29640
        • Recruiting
        • Prisma Health Cancer Institute - Easley
        • Principal Investigator:
          • Ki Y. Chung
        • Contact:
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health Cancer Institute - Faris
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
        • Principal Investigator:
          • Ki Y. Chung
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health Cancer Institute - Butternut
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
        • Principal Investigator:
          • Ki Y. Chung
      • Greenville, South Carolina, United States, 29615
        • Recruiting
        • Prisma Health Cancer Institute - Eastside
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
        • Principal Investigator:
          • Ki Y. Chung
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Prisma Health Greenville Memorial Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
        • Principal Investigator:
          • Ki Y. Chung
      • Greer, South Carolina, United States, 29650
        • Recruiting
        • Prisma Health Cancer Institute - Greer
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
        • Principal Investigator:
          • Ki Y. Chung
      • Seneca, South Carolina, United States, 29672
        • Recruiting
        • Prisma Health Cancer Institute - Seneca
        • Contact:
          • Site Public Contact
          • Phone Number: 864-241-6251
        • Principal Investigator:
          • Ki Y. Chung
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University/Ingram Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-811-8480
        • Principal Investigator:
          • Cathy Eng
    • Texas
      • Amarillo, Texas, United States, 79106
        • Recruiting
        • The Don and Sybil Harrington Cancer Center
        • Contact:
        • Principal Investigator:
          • Anita Ravipati
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern/Simmons Cancer Center-Dallas
        • Contact:
        • Principal Investigator:
          • Syed M. Kazmi
      • Dallas, Texas, United States, 75237
        • Recruiting
        • UT Southwestern Simmons Cancer Center - RedBird
        • Contact:
        • Principal Investigator:
          • Syed M. Kazmi
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • UT Southwestern/Simmons Cancer Center-Fort Worth
        • Contact:
        • Principal Investigator:
          • Syed M. Kazmi
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Van K. Morris
      • Richardson, Texas, United States, 75080
        • Recruiting
        • UT Southwestern Clinical Center at Richardson/Plano
        • Contact:
        • Principal Investigator:
          • Syed M. Kazmi
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute/University of Utah
        • Principal Investigator:
          • Christopher D. Nevala-Plagemann
        • Contact:
    • Vermont
      • Saint Johnsbury, Vermont, United States, 05819
        • Recruiting
        • Norris Cotton Cancer Center-North
        • Contact:
        • Principal Investigator:
          • Gabriel A. Brooks
    • Washington
      • Issaquah, Washington, United States, 98029
        • Recruiting
        • Swedish Cancer Institute-Issaquah
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center-First Hill
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
    • West Virginia
      • Bridgeport, West Virginia, United States, 26330
        • Recruiting
        • United Hospital Center
        • Contact:
        • Principal Investigator:
          • Nour Daboul
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University Healthcare
        • Contact:
        • Principal Investigator:
          • Nour Daboul
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • Recruiting
        • ThedaCare Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Matthias Weiss
      • Ashland, Wisconsin, United States, 54806
        • Recruiting
        • Duluth Clinic Ashland
        • Contact:
        • Principal Investigator:
          • Bret E. Friday
      • Burlington, Wisconsin, United States, 53105
        • Recruiting
        • Aurora Cancer Care-Southern Lakes VLCC
        • Contact:
        • Principal Investigator:
          • Edward S. James
      • Cudahy, Wisconsin, United States, 53110
        • Recruiting
        • Aurora Saint Luke's South Shore
        • Contact:
        • Principal Investigator:
          • Edward S. James
      • Eau Claire, Wisconsin, United States, 54701
      • Germantown, Wisconsin, United States, 53022
        • Recruiting
        • Aurora Health Care Germantown Health Center
        • Contact:
        • Principal Investigator:
          • Edward S. James
      • Green Bay, Wisconsin, United States, 54311
        • Recruiting
        • Aurora BayCare Medical Center
        • Contact:
        • Principal Investigator:
          • Edward S. James
      • Kenosha, Wisconsin, United States, 53142
        • Recruiting
        • Aurora Cancer Care-Kenosha South
        • Contact:
        • Principal Investigator:
          • Edward S. James
      • Marinette, Wisconsin, United States, 54143
        • Recruiting
        • Aurora Bay Area Medical Group-Marinette
        • Contact:
        • Principal Investigator:
          • Edward S. James
      • Marshfield, Wisconsin, United States, 54449
      • Milwaukee, Wisconsin, United States, 53209
        • Recruiting
        • Aurora Cancer Care-Milwaukee
        • Contact:
        • Principal Investigator:
          • Edward S. James
      • Minocqua, Wisconsin, United States, 54548
      • Mukwonago, Wisconsin, United States, 53149
        • Recruiting
        • ProHealth D N Greenwald Center
        • Contact:
        • Principal Investigator:
          • Timothy R. Wassenaar
      • New Richmond, Wisconsin, United States, 54017
        • Recruiting
        • Cancer Center of Western Wisconsin
        • Contact:
        • Principal Investigator:
          • David M. King
      • Oconomowoc, Wisconsin, United States, 53066
        • Recruiting
        • ProHealth Oconomowoc Memorial Hospital
        • Principal Investigator:
          • Timothy R. Wassenaar
        • Contact:
          • Site Public Contact
          • Phone Number: 262-928-7878
      • Oshkosh, Wisconsin, United States, 54904
        • Recruiting
        • Vince Lombardi Cancer Clinic - Oshkosh
        • Contact:
        • Principal Investigator:
          • Edward S. James
      • Racine, Wisconsin, United States, 53406
        • Recruiting
        • Aurora Cancer Care-Racine
        • Contact:
        • Principal Investigator:
          • Edward S. James
      • Sheboygan, Wisconsin, United States, 53081
        • Recruiting
        • Vince Lombardi Cancer Clinic-Sheboygan
        • Contact:
        • Principal Investigator:
          • Edward S. James
      • Stevens Point, Wisconsin, United States, 54482
      • Two Rivers, Wisconsin, United States, 54241
        • Recruiting
        • Vince Lombardi Cancer Clinic-Two Rivers
        • Contact:
        • Principal Investigator:
          • Edward S. James
      • Waukesha, Wisconsin, United States, 53188
        • Recruiting
        • UW Cancer Center at ProHealth Care
        • Principal Investigator:
          • Timothy R. Wassenaar
        • Contact:
      • Weston, Wisconsin, United States, 54476

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (encorafenib, cetuximab, nivolumab)
Patients 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.
Biological: Nivolumab
Given IV
Other Names:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo
  • CMAB819
  • Nivolumab Biosimilar CMAB819
  • ABP 206
  • Nivolumab Biosimilar ABP 206
  • BCD-263
  • Nivolumab Biosimilar BCD-263
Drug: Encorafenib
Given PO
Other Names:
  • Braftovi
  • LGX 818
  • LGX-818
  • LGX818
Biological: Cetuximab
Given IV
Other Names:
  • C225
  • Erbitux
  • IMC-C225
  • Cetuximab Biosimilar CDP-1
  • Cetuximab Biosimilar CMAB009
  • Cetuximab Biosimilar KL 140
  • Chimeric Anti-EGFR Monoclonal Antibody
  • Chimeric MoAb C225
  • Chimeric Monoclonal Antibody C225
Active Comparator: Arm II (encorafenib, cetuximab)
Patients 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.
Drug: Encorafenib
Given PO
Other Names:
  • Braftovi
  • LGX 818
  • LGX-818
  • LGX818
Biological: Cetuximab
Given IV
Other Names:
  • C225
  • Erbitux
  • IMC-C225
  • Cetuximab Biosimilar CDP-1
  • Cetuximab Biosimilar CMAB009
  • Cetuximab Biosimilar KL 140
  • Chimeric Anti-EGFR Monoclonal Antibody
  • Chimeric MoAb C225
  • Chimeric Monoclonal Antibody C225

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: Up to 3 years
Evaluated per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (confirmed and unconfirmed, complete and partial response) and compared across treatment arms via Fisher's exact test.
Up to 3 years
Overall survival (OS)
Time Frame: From date of registration to date of death due to any cause, assessed up to 3 years
Estimated using the Kaplan-Meier method and compared using the stratified log rank test. The distribution of OS will be estimated using the method of Kaplan-Meier and compared using the stratified log rank test.
From date of registration to date of death due to any cause, assessed up to 3 years
Duration of response (DoR)
Time Frame: 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
Estimated using the Kaplan-Meier method and compared using the stratified log rank test. The distribution of DoR will be estimated using the method of Kaplan-Meier and compared using the stratified log rank test.
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
Time Frame: 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
The distribution of irRC-PFS in Arm 1 (nivolumab + encorafenib + cetuximab) will be estimated using the method of Kaplan-Meier.
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
Time Frame: Up to 3 years
At least 25 eligible participants in each arm are sufficient to estimate the probability of a particular toxicity within ±20% (95% confidence interval), and any toxicity occurring with at least 10% probability is likely (93% chance) to be seen at least once. At least 50 eligible participants are sufficient to estimate the probability of a particular toxicity within ±14% (95% confidence interval), and any toxicity occurring with at least 5% probability is likely (92% chance) to be seen at least once.
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Van K Morris, SWOG Cancer Research Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2022

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

April 1, 2022

First Submitted That Met QC Criteria

April 1, 2022

First Posted (Actual)

April 4, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2022-02494 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA180888 (U.S. NIH Grant/Contract)
  • S2107 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

"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."

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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