# CheckMate 649

Source: https://onco.cc/trials/checkmate-649/  
OnCo record `checkmate-649` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The trial that added immunotherapy to first-line stomach cancer chemotherapy; at five years, 16% of patients with PD-L1-rich tumours were alive versus 6%.

## Summary

CheckMate 649, trial NCT02872116 sponsored by Bristol Myers Squibb and reported in 2020, is the largest phase 3 in gastric cancer and the trial that added immunotherapy to first-line chemotherapy, with a durable minority of long-term survivors among patients with PD-L1-rich tumours at five years. It randomised 1,581 patients with HER2-negative gastric, gastro-oesophageal junction or oesophageal adenocarcinoma to nivolumab plus chemotherapy or chemotherapy and met its primary overall survival endpoint in the PD-L1 CPS 5 or higher population, with a smaller benefit in all randomised patients; the FDA approved it for all patients in 2021 while the EMA and many guidelines restrict it to CPS 5 or higher. Whether PD-L1-low patients gain anything is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT02872116
- Phase: 3
- Setting: First-line HER2-negative advanced gastric/GEJ/oesophageal adenocarcinoma: nivolumab + chemotherapy vs chemotherapy
- Sponsor: BMS
- Enrolled: 1581
- Result: CPS ≥5: OS 14.4 vs 11.1 months (HR 0.71); 5-year OS 16% vs 6%.
- Outcomes: Overall survival, PD-L1 CPS ≥5: Nivolumab + chemotherapy 14.4 months vs Chemotherapy 11.1 months, HR 0.71; Overall survival at 5 years, CPS ≥5: Nivolumab + chemotherapy 16 percent vs Chemotherapy 6 percent
- Replication: Replicated by KEYNOTE-859 (pembrolizumab), RATIONALE-305 (tislelizumab), and ORIENT-16 (sintilimab).

## Sources

- ClinicalTrials.gov NCT02872116: https://clinicaltrials.gov/study/NCT02872116
- 5-year follow-up, Annals of Oncology 2026: https://www.annalsofoncology.org/article/S0923-7534(26)00059-1/fulltext

## Connected records

- cancers: [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/), [Microsatellite-unstable (MSI-high) gastric cancer](https://onco.cc/cancers/gastric-msi-high/), [Oesophageal cancer](https://onco.cc/cancers/esophageal/), [PD-L1-high gastric cancer](https://onco.cc/cancers/gastric-pdl1-high/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- targets: [PD-1](https://onco.cc/targets/pd1/), [PD-L1](https://onco.cc/targets/pdl1/)
- drugs: [CAPOX (capecitabine, oxaliplatin)](https://onco.cc/drugs/capox/), [FOLFOX (5-FU, leucovorin, oxaliplatin)](https://onco.cc/drugs/folfox/), [Nivolumab](https://onco.cc/drugs/nivolumab/)
- terms: [Combined positive score (CPS)](https://onco.cc/terms/cps/)
- people: [Jaffer A. Ajani](https://onco.cc/people/jaffer-ajani/), [Won Ki Kang](https://onco.cc/people/kang-won-ki/), [Yelena Y. Janjigian](https://onco.cc/people/yelena-janjigian/)
- ideas: [Biomarker-directed first-line quadruplets in gastric cancer](https://onco.cc/ideas/idea-biomarker-quadruplet-gastric/)
- roadmaps: [Chemotherapy roadmap: mustard gas → curative combinations → the warhead inside smarter drugs](https://onco.cc/roadmaps/chemotherapy-roadmap/)

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