An Investigational Immunotherapy Study of Nivolumab With Standard of Care Therapy vs Standard of Care Therapy for First-Line Treatment of Colorectal Cancer That Has Spread (CheckMate 9X8)
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ClinicalTrials.gov Identifier: NCT03414983 |
Recruitment Status :
Active, not recruiting
First Posted : January 30, 2018
Last Update Posted : July 15, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer | Biological: Nivolumab Drug: Oxaliplatin Drug: Leucovorin Drug: Fluorouracil Drug: Bevacizumab | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 180 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label Exploratory Phase 2/3 Study of Nivolumab With Standard of Care Therapy vs Standard of Care Therapy for First-Line Treatment of Metastatic Colorectal Cancer |
Actual Study Start Date : | February 14, 2018 |
Estimated Primary Completion Date : | August 16, 2021 |
Estimated Study Completion Date : | August 18, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm A
Nivo + SOC
|
Biological: Nivolumab
Specified dose on specified days
Other Names:
Drug: Oxaliplatin Specified dose on specified day Drug: Leucovorin Specified Dose on specified days
Other Name: Calcium Folinate Drug: Fluorouracil Specified dose on specified days Drug: Bevacizumab Specified dose on specified days
Other Name: Avastin |
Active Comparator: Arm B
SOC
|
Drug: Oxaliplatin
Specified dose on specified day Drug: Leucovorin Specified Dose on specified days
Other Name: Calcium Folinate Drug: Fluorouracil Specified dose on specified days Drug: Bevacizumab Specified dose on specified days
Other Name: Avastin |
- Progression Free Survival (PFS) [ Time Frame: Approximately 28 months ]assessed by a Blinded Independent Central Review Committee (BICR) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1)
- Objective Response Rate (ORR) [ Time Frame: Approximately 28 months ]assessed by a BICR per RECIST v1.1
- Disease Control Rate (DCR) [ Time Frame: Approximately 28 months ]assessed by a BICR per RECIST v1.1
- Duration of Response (DoR) [ Time Frame: Approximately 28 months ]assessed by a BICR per RECIST v1.1
- Time to Response (TTR) [ Time Frame: Approximately 28 months ]assessed by a BICR per RECIST v1.1
- Overall Survival (OS) [ Time Frame: Approximately 28 months ]
- Number of Adverse Events ( AEs) [ Time Frame: Approximately 28 months ]
- Number of Serious Adverse Events ( SAEs) [ Time Frame: Approximately 28 months ]
- Number of deaths [ Time Frame: Approximately 28 months ]
- Number of clinical abnormalities [ Time Frame: Approximately 28 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Histologically confirmed metastatic colorectal cancer, not amenable to curative resection
- No prior chemotherapy for metastatic colorectal cancer
- ECOG Performance Status of 0-1
- Ability to provide adequate tissue sample
Exclusion Criteria:
- Patients with clinically relevant medical history, including autoimmune disease, cardiovascular disease, hepatic disease or bleeding disorders
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus
Other protocol defined inclusion/exclusion criteria could apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414983

Study Director: | Bristol-Myers Squibb | Bristol-Myers Suibb |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT03414983 |
Other Study ID Numbers: |
CA209-9X8 2017-003662-27 ( EudraCT Number ) |
First Posted: | January 30, 2018 Key Record Dates |
Last Update Posted: | July 15, 2020 |
Last Verified: | July 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Leucovorin Bevacizumab Nivolumab Fluorouracil |
Oxaliplatin Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Antidotes Protective Agents |