# CheckMate 577

Source: https://onco.cc/trials/checkmate-577/  
OnCo record `checkmate-577` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A year of immunotherapy after surgery doubled the time before cancer returned in patients whose tumour had not fully responded to chemoradiation, though the survival gain did not reach significance.

## Summary

CheckMate 577, trial NCT02743494 sponsored by Bristol Myers Squibb and reported in 2021, showed that a year of adjuvant nivolumab doubled the time before cancer returned in patients with oesophageal or gastro-oesophageal junction cancer whose tumour had not fully responded to neoadjuvant chemoradiation and surgery, though the survival gain did not reach significance. It randomised 794 patients with residual disease to nivolumab or placebo and met its primary disease-free survival endpoint, the basis of the 2021 FDA approval, while the final overall survival analysis at ASCO 2025 favoured nivolumab without statistical significance. It remains standard in NCCN and ESMO guidance, and whether a disease-free benefit without a survival benefit should be enough is the open question.

## Fields

- Kind: Trial
- Status: mixed
- Last checked: 2026-09-07
- Registry id: NCT02743494
- Phase: 3
- Setting: Resected oesophageal/GEJ cancer with residual disease after neoadjuvant chemoradiation: adjuvant nivolumab 1 year vs placebo
- Sponsor: BMS
- Enrolled: 794
- Result: DFS 22.4 vs 11.0 months (HR 0.69); OS 51.7 vs 35.3 months (HR 0.85, NS).
- Outcomes: Disease-free survival: Nivolumab 22.4 months vs Placebo 11 months, HR 0.69; Overall survival (final): Nivolumab 51.7 months vs Placebo 35.3 months, HR 0.85
- Replication: Single phase 3; real-world matched cohorts show similar OS direction.

## Sources

- ClinicalTrials.gov NCT02743494: https://clinicaltrials.gov/study/NCT02743494
- Final OS, ASCO 2025: https://ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.4000

## Connected records

- cancers: [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/), [Oesophageal and junctional adenocarcinoma](https://onco.cc/cancers/oesophageal-adenocarcinoma/), [Oesophageal cancer](https://onco.cc/cancers/esophageal/), [Oesophageal squamous cell carcinoma](https://onco.cc/cancers/oesophageal-squamous-cell-carcinoma/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- targets: [PD-1](https://onco.cc/targets/pd1/)
- drugs: [Nivolumab](https://onco.cc/drugs/nivolumab/)
- terms: [De-escalation, escalation and response-adapted therapy](https://onco.cc/terms/de-escalation/), [Neoadjuvant / adjuvant / perioperative](https://onco.cc/terms/neoadjuvant-adjuvant/)
- trials: [CROSS](https://onco.cc/trials/cross/)
- people: [Ronan J. Kelly](https://onco.cc/people/ronan-kelly/)
- pairings: [CROSS chemoradiation → surgery → adjuvant nivolumab if residual disease](https://onco.cc/pairings/cross-then-nivolumab/)
- key papers: [CheckMate 577: adjuvant nivolumab in resected oesophageal or gastro-oesophageal junction cancer](https://onco.cc/key-papers/paper-checkmate-577-nejm-2021/)

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