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Comparing Three Drugs as Late-Stage Treatment for Individuals with Metastatic Colorectal Cancer

Clinicaltrials.gov identifier:
NCT05328908

Treatment
treatment study for people with metastatic colorectal cancer

Study Contact Information:

For additional information, please contact:

BMS Study Connect Contact Center by phone at (855) 907-3286

or by email at [email protected]. The first line of the email must contain NCT05328908 and the Site #

 


Comparing Three Drugs as Late-Stage Treatment for Individuals with Metastatic Colorectal Cancer

About the Study

This study is being done to look at how well a combination of three drugs works for the treatment of colorectal cancer in patients who have had their cancer come back or get worse after treatment. The study is open to people who have had at least one, but no more than four courses of treatment in the setting. 

What the Study Entails

Participants will be randomly selected to participate in either group and they will know which treatment they are receiving.

This study has two groups:

  • Group 1: Patients will receive Opdualag, which is a combination of two drugs, nivolumab and relatlimab, injected into the vein.
  • Group 2: Patients will receive either Stivarga (regorafenib) orally or Lonsurf orally.

Study Sites

Arkansas

  • Springdale
    Highlands Oncology Group - Springdale (Site 0044)
    Contact: J. Thaddeus Beck (479) 872-8130

California

  • Los Angeles
    USC Norris Comprehensive Cancer Center (Site 0012)
    Contact: Heinz-Josef Lenz (323) 865-3967

Connecticut

  • Norwich
    Eastern Connecticut HEmatology and Oncology (Site 0117)
    Contact: Dennis Slater (860) 886-8362

Florida

  • Miami
    Baptist Hospital of Miami (Site 0025)
    Contact: Antonio Ucar (305) 607-8732

Georgia

  • Atlanta
    Northside Hospital (Site 0031)
    Contact: Ioana Bonta (773) 814-8646

Idaho

  • Boise
    St. Luke’s Cancer Institute - Boise (Site 0071)
    Contact: Dan Zuckerman

Indiana

  • Fort Wayne
    Fort Wayne Medical Oncology and Hematology (Site 0081)
    Contact: Sunil Babu (260) 436-0800

Massachusetts

  • Boston
    Massachusetts General Hospital (Site 0140)
    Contact: Aparna Parikh (847) 971-3738

Michigan

  • Ann Arbor
    University of Michigan - Rogel Cancer Center (Site 0042)
    Contact: John Krauss (734) 645-3109

New Jersey

  • East Brunswick
    Astera Cancer Care (Site 0043)
    Contact: Phillip Reid (617) 632-2000

North Carolina

  • Durham
    Duke University Medical Center (Site 0009)
    Contact: Michael Morse (919) 681-3480

Ohio

  • Cincinnati
    Good Samaritan Hospital (Site 0082)
    Contact: David Draper (513) 442-5561
  • Columbus
    The James Cancer Hospital and Solove Research Institute at the Ohio State
    University Comprehensive Center (Site 0079)
    Contact: Anne Noonan (614) 293-9496
  • Columbus
    The James Cancer Hospital (Site 0095)
    Contact: Pannaga Malalur (614) 293-3717

Pennsylvania

  • Philadelphia
    Thomas Jefferson University - Clinical Trials Office-Medical Oncology (Site 0130)
    Contact: Atrayee Basu-Mallick (347) 267-7604
  • Philadelphia
    Fox Chase Cancer Center (Site 0147)
    Contact: Namrata Vijayvergia (215) 214-1676

South Carolina

  • Charleston
    Roper Hospital (Site 0008)
    Contact: David Ellison (843) 577-6957

South Dakota

  • Sioux Falls
    Sanford Research (Site 0096)
    Contact: Jonathan Bleeker (605) 328-8000

Tennessee

  • Nashville
    Tennessee Oncology (Site 0127)
    Contact: Meredith Pelster (615) 329-7274

Texas

  • Fort Worth
    The Center For Cancer and Blood Disorders (Site 0097)
    Contact: Henry Xiong (817) 759-7000

Virginia

  • Richmond
    Virginia Commonwealth University Massey Cancer Center (Site 0132)
    Contact: Khalid Matin (608) 265-1700

Wisconsin

  • Madison
    University of Wisconsin-Madison - Wisconsin Institutes for Medical Research (Site 0005)
    Contact: Dustin Deming (608) 265-1700

 

 

 

This Study is Open To:

Patients 18 years or older who:

  • have confirmed previously treated colorectal cancer
  • have tumor tissue for testing
  • have measurable disease
  • have had their cancer get worse during or within 3 months following their past treatment OR
  • could not tolerate prior chemotherapy 

 

This Study is Not Open To:

Patients who:

  • have had prior treatments with either an , or with the treatments being used in this study
  • have untreated central nervous system (CNS) metastases
  • have confirmed MSI-H ( high) or (deficient mismatch repair) tumor status

Other exclusion criteria can be found on clinicaltrials.gov