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Showed two immunotherapy options for squamous oesophageal cancer, including one with no chemotherapy at all, both extending survival.
CheckMate 648, trial NCT03143153 sponsored by Bristol Myers Squibb and reported in 2021, showed two immunotherapy options for first-line advanced oesophageal squamous cell carcinoma, nivolumab plus chemotherapy and a chemotherapy-free doublet of nivolumab plus ipilimumab, both extending survival. It randomised 970 patients across three arms and met its primary overall survival endpoint in PD-L1-positive patients for both regimens, with benefit in all randomised patients and durable separation confirmed at five-year follow-up in 2026, leading to FDA approval of both regimens in May 2022. OnCo links it to oesophageal cancer, PD-1 and CTLA-4 as targets, nivolumab, ipilimumab and Jaffer A. Ajani. Which patients are best served by avoiding chemotherapy altogether is the open question.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
970 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival, PD-L1 ≥1% (nivolumab + chemotherapy)primary | Nivolumab + chemotherapy | - | 15.4 months | 0.54 | - | link |
| Chemotherapy | - | 9.1 months | ||||
| Overall survival, PD-L1 ≥1% (nivolumab + ipilimumab) | Nivolumab + ipilimumab | - | 13.7 months | 0.64 | - | link |
| Chemotherapy | - | 9.1 months |
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares CheckMate 648: nivolumab combination therapy in advanced oesophageal squamous cell carcinoma, Oesophageal squamous cell carcinoma, Oesophageal cancer.
Shares CTLA-4, Ipilimumab, Nivolumab, PD-1.
Shares CTLA-4, Ipilimumab, Nivolumab, PD-1.
Shares CTLA-4, Ipilimumab, Nivolumab, PD-1.
Shares Oesophageal squamous cell carcinoma, Oesophageal cancer, Nivolumab, Immune checkpoint inhibitors.
Shares CTLA-4, Ipilimumab, Nivolumab, PD-1.
Shares CTLA-4, Ipilimumab, Nivolumab, PD-1.
Shares Oesophageal squamous cell carcinoma, Oesophageal cancer, Immune checkpoint inhibitors.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/