Nivolumab, Nivolumab Plus Ipilimumab, or Chemotherapy for Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (CheckMate 8HW)
Clinicaltrials.gov identifier:
NCT04008030
Treatment
People with metastatic colorectal cancer that is MSI-High
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 agents nivolumab (Opdivo) plus ipilimumab (Yervoy) in patients who have High (MSI-H) or Mismatch Repair Deficient () colorectal cancer versus using nivolumab as a single therapy or chemotherapy.
Type of Study
This is a 3-arm, , , 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 . Patients will be selected by chance and placed into one of the three groups.
- The study is , 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 |
- Sacramento: University of California Davis Medical Center
Contact: May Cho: 916-734-3604
- Denver: Rocky Mountain Cancer Centers
Contact: Allen Cohn: 303-388-0136
- Arlington Heights: Illinois Cancer Specialists
Contact: Richard Siegel, Site 0119
- New York City: Memorial Sloan Kettering Nassau
Contact: Neil Segal, Site 0060 646-888-1396
- Portland: Northwest Cancer Specialists (Broadway) - USOR
Contact: Spencer Shao, Site 0105 503-231-2612
- Pittsburgh: UPMC Hillman Cancer Center
Contact: Anuradha Krishnamurthy, Site 0121 412-623-8364
- Dallas: Texas Oncology Sammons Cancer Center
Contact: Andrew Scott Paulson, Site 0106 214-370-1987
- Roanoke: Oncology & Hematology Associates Of Southwest Virginia, Inc.
Contact: Mark Kochenderfer, Site 0104 540-982-0237
Other Countries
Country: China
State: Fujian
City: Xiamen RECRUITING
Facility: The First Affiliated hospital of Xiamen University
Contact Info:
8613860458889
Country: China
State: Fujian
City: Zhangzhou RECRUITING
Facility: Zhangzhou Municipal Hospital of Fujian Province
Contact Info:
+8613906062816
Country: China
State: Gansu
City: Lanzhou RECRUITING
Facility: Lanzhou university second hospital
Contact Info:
0931-8487117
Country: China
State: Guangdong
City: Foshan RECRUITING
Facility: The First People's Hospital of Foshan
Contact Info:
8618038863618
Country: China
State: Guangdong
City: Guangzhou RECRUITING
Facility: Local Institution - 0167
Contact Info:
Country: China
State: Guangdong
City: Guangzhou RECRUITING
Facility: The Sixth Affiliated Hospital of Sun Yat-sen University
Contact Info:
8613925106525
Country: China
State: Guangxi
City: Nanning RECRUITING
Facility: The people's hospital of Guangxi Zhuang autonomous region
Contact Info:
13877122406
Country: China
State: Guangxi
City: Nanning RECRUITING
Facility: Guangxi Medical University Affiliated Tumor Hospital
Contact Info:
13457161928
Country: China
State: Heilongjiang
City: Harbin RECRUITING
Facility: Harbin Medical University Cancer Hospital
Contact Info:
+8613845120210
Country: China
State: Henan
City: Zhengzhou RECRUITING
Facility: The First Affiliated Hospital of Zhengzhou University
Contact Info:
+8613633862757
Country: China
State: Hunan
City: Changsha RECRUITING
Facility: Hunan Cancer Hospital
Contact Info:
8613319602869
Country: China
State: Jiangsu
City: Changzhou RECRUITING
Facility: The First People's Hospital of Changzhou
Contact Info:
+8613912330886
Country: China
State: Jiangxi
City: Nanchang RECRUITING
Facility: The 1st Affiliate Hospital Of Nanchang University
Contact Info:
+8613879109229
Country: China
State: Jilin
City: Changchun RECRUITING
Facility: The 1st Hospital Of Jilin University
Contact Info:
8613756661267
Country: China
State: Liaoning
City: Shenyang RECRUITING
Facility: Liaoning Cancer Hospital and Institute
Contact Info:
+862431936391
Country: China
State: Shandong
City: Jinan RECRUITING
Facility: Shandong Cancer Hospital
Contact Info:
13506413687
Country: China
State: Shandong
City: Linyi RECRUITING
Facility: Local Institution - 0212
Contact Info:
Country: China
State: Shandong
City: Qingdao RECRUITING
Facility: Local Institution - 0154
Contact Info:
Country: China
State: Shanghai
City: Shanghai RECRUITING
Facility: Shanghai East Hospital
Contact Info:
8613310167477
Country: China
State: Shanghai
City: Shanghai RECRUITING
Facility: Shanghai GoBroad Cancer Hospital China Pharmaceutical University
Contact Info:
13901906998
Country: China
State: Yunnan
City: Kunming RECRUITING
Facility: Yunnan Province Cancer Hospital
Contact Info:
13330445776
Country: China
State: Zhejiang
City: Hangzhou RECRUITING
Facility: The 2nd Affiliated Hospital Of Z.U.S.M
Contact Info:
8613858193601
Country: China
State: Zhejiang
City: Ningbo RECRUITING
Facility: Local Institution - 0206
Contact Info:
People age 18 years or older, are eligible if they have:
- Recurrent or colorectal cancer (CRC) irrespective of prior treatment history
OR
- Recurrent or CRC and no prior treatment history with chemotherapy and/or targeted agents for disease
- Tumor tissue confirmed as MSI-H or status
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