Phase 3
Completed N=195
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
Source: ClinicalTrials.gov NCT03414983 ↗Enrolled (actual)
195
Serious AEs
49.7%
Results posted
Feb 2022
Primary outcomePrimary: Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR) — 11.86; 11.93 Months — p=0.3022
◆ Published Evidence
Established
67citations · ~34 / year
Modified FOLFOX6 plus bevacizumab with and without nivolumab for first-line treatment of metastatic colorectal cancer: phase 2 results from the CheckMate 9X8 randomized clinical trial.
Summary
This purpose of this study is to evaluate nivolumab (BMS-936558) in combination with standard of care (SOC) chemotherapy with bevacizumab for the treatment of first-line metastatic colorectal cancer (mCRC).
Linked Publications
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Modified FOLFOX6 plus bevacizumab with and without nivolumab for first-line treatment of metastatic colorectal cancer: phase 2 results from the CheckMate 9X8 randomized clinical trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR) |
11.86; 11.93 | 0.3022 |
| SECONDARY Progression Free Survival (PFS) Per Investigator Assessment |
13.77; 12.19 | — |
| SECONDARY Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) |
60.6; 45.6 | — |
| SECONDARY Objective Response Rate (ORR) Per Investigator Assessment |
60.6; 52.9 | — |
| SECONDARY Duration of Response (DoR) Per Blinded Independent Central Review (BICR) |
12.88; 9.26 | — |
| SECONDARY Duration of Response (DoR) Per Investigator Assessment |
12.48; 11.07 | — |
| SECONDARY Time to Objective Response Per Blinded Independent Central Review (BICR) |
2.83; 2.83 | — |
| SECONDARY Time to Objective Response Per Investigator Assessment |
2.83; 2.83 | — |
| SECONDARY Overall Survival (OS) |
30.52; 31.77 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
122; 61 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) |
57; 20 | — |
| SECONDARY Number of Participants Experiencing Death |
87; 42 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities in Specific Liver Tests |
16; 6; 7; 2; 2; 0 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests |
45; 23; 37; 16; 20; 2 | — |
| SECONDARY Disease Control Rate (DCR) Per Blinded Independent Central Review (BICR) |
91.3; 83.8 | — |
| SECONDARY Disease Control Rate (DCR) Per Investigator |
85.8; 77.9 | — |
Eligibility Criteria
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 apply
Data sourced from ClinicalTrials.gov (NCT03414983) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.