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Nivolumab, Nivolumab Plus Ipilimumab, or Chemotherapy for Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (CheckMate 8HW)

Nivolumab, Nivolumab Plus Ipilimumab, or Chemotherapy for Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (CheckMate 8HW)

Clinicaltrials.gov identifier:
NCT04008030

Treatment:
Colorectal

Study Contact Information:

For more information please email Clinical.Trials@bms.com reference NCT04008030 in the subject line and email body. 


A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC) (CheckMate 8HW)

About the Study

The purpose of this study is to compare the benefit of the combination of immunotherapy agents nivolumab (Opdivo) plus ipilimumab (Yervoy) in patients who have Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer versus using nivolumab as a single therapy or chemotherapy. 

 

Type of Study

This is a 3-arm, randomized, open-label, phase 3 study.  

  • The study has 3-arms
    • Patients assigned to Group 1 will receive will receive nivolumab as a single therapy.
    • Patients assigned to Group 2 will receive a combination of nivolumab plus ipilimumab.
    • Patients assigned to Group 3 will receive their doctor's choice of chemotherapy. 
  • The study is randomized. Patients will be selected by chance and placed into one of the three groups.
  • The study is open-label, all patients will know which group they have been placed into. 


What the Study Entails

Group 1 treatment

People in Group 1 will receive nivolumab as a single therapy.   

Group 2 treatment

Patients in Group 2 will receive a combination of nivolumab plus ipilimumab.

Group 3 treatment

Patients in group 3 will receive their doctor's choice of chemotherapy agents. Patients in this group would also be allowed to receive the nivolumab + ipilimumab combination therapy if their disease progresses.

Followup

Patients will be followed up to five years.


Study Sites

California Colorado Illinois New York Oregon
Pennsylvania Texas Virginia    

 

California

  • Sacramento: University of California Davis Medical Center
    Contact: May Cho: 916-734-3604     

Colorado

  • Denver: Rocky Mountain Cancer Centers 
    Contact: Allen Cohn: 303-388-0136     

Illinois

  • Arlington Heights: Illinois Cancer Specialists  
    Contact: Richard Siegel, Site 0119        

New York

  • New York City: Memorial Sloan Kettering Nassau
    Contact: Neil Segal, Site 0060    646-888-1396 

Oregon

  • Portland: Northwest Cancer Specialists (Broadway) - USOR     
    Contact: Spencer Shao, Site 0105    503-231-2612   

Pennsylvania

  • Pittsburgh: UPMC Hillman Cancer Center     
    Contact: Anuradha Krishnamurthy, Site 0121    412-623-8364     

Texas

  • Dallas: Texas Oncology Sammons Cancer Center      
    Contact: Andrew Scott Paulson, Site 0106    214-370-1987     

Virginia

  • Roanoke: Oncology & Hematology Associates Of Southwest Virginia, Inc.      
    Contact: Mark Kochenderfer, Site 0104    540-982-0237     
This Study is Open To:

Men and Women, age 18 years or older, are eligible if they have:

  • Recurrent or metastatic colorectal cancer (CRC) irrespective of prior treatment history

OR

  • Recurrent or metastatic CRC and no prior treatment history with chemotherapy and/or targeted agents for metastatic disease
    • Tumor tissue confirmed as MSI-H or dMMR status
This Study is Not Open To:

People with a history of the following cannot participate

  • An active or suspected autoimmune disease
  • History of interstitial lung disease (scarring and inflammation of the tissue that surrounds the lung's air sacs, blood vessels and airways) or pneumonitis (inflammation of the lung tissue)
  • History of HIV or AIDS