A newer report of this study has been published: Nivolumab plus chemotherapy or ipilimumab versus chemotherapy as first-line treatment for advanced esophageal squamous cell carcinoma: 5-year follow-up results from CheckMate 648 (2026)
In the squamous type of advanced oesophageal cancer, adding immunotherapy with nivolumab to chemotherapy, or combining two immunotherapy drugs (nivolumab and ipilimumab) without chemotherapy, helped patients live longer than chemotherapy alone. The benefit was greater in patients whose tumour expresses the PD-L1 protein, which is why testing the tumour sample for PD-L1 before deciding on treatment matters. Follow-up over 5 years showed that this benefit has lasted.
First line, with a fluoropyrimidine and platinum
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Continuous | |||
| Nivolumab | 240 mg every 2 weeks or 480 mg every 4 weeks | IV, 30-minute infusion | Day 1 (given first) |
| Fluoropyrimidine + platinum | As per those drugs' labels | IV | Same day, after nivolumab |
First line, advanced unresectable or metastatic
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Continuous | |||
| Nivolumab | 3 mg/kg every 2 weeks or 360 mg every 3 weeks | IV, 30-minute infusion | Day 1 |
| Ipilimumab | 1 mg/kg | IV, 30-minute infusion | Every 6 weeks |
On the page “Ipilimumab (Yervoy)” · Other cancers, with nivolumab (FDA label, revised 08/2026)
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Nivolumab 240 mg IV on days 1 and 15, with fluorouracil 800 mg/m² per day IV on days 1 to 5 and cisplatin 80 mg/m² IV on day 1 (4-week cycles); nivolumab until disease progression, intolerable toxicity or a maximum of 2 years.
Nivolumab 3 mg/kg every 2 weeks with ipilimumab 1 mg/kg every 6 weeks; until disease progression, intolerable toxicity or a maximum of 2 years.
Fluorouracil 800 mg/m² per day on days 1 to 5 and cisplatin 80 mg/m² on day 1, in 4-week cycles.
Source of the regimen details: Doses confirmed from the Clinical Studies section of the FDA label for nivolumab (CHECKMATE-648).
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Adults with unresectable advanced, recurrent or metastatic oesophageal squamous-cell carcinoma who had received no prior systemic therapy and were not candidates for curative chemoradiotherapy or surgery. Hierarchical testing was done first in patients with tumour-cell PD-L1 expression of 1% or more and then in the overall population.
Primary endpoints: overall survival and progression-free survival (by blinded independent central review) in patients with tumour-cell PD-L1 ≥1%. Key secondary endpoints: the same outcomes in the overall population.
Treatment-related grade 3 or 4 adverse events occurred in 47% of the nivolumab + chemotherapy group, 32% of the nivolumab + ipilimumab group and 36% of the chemotherapy-alone group.
Based on this trial, nivolumab with fluoropyrimidine- and platinum-based chemotherapy, and nivolumab with ipilimumab, have been approved for first-line treatment of advanced or metastatic oesophageal squamous-cell carcinoma; in the current FDA label this approval is limited to tumours with PD-L1 expression ≥1. Follow-up of at least 5 years (Kato et al., Ann Oncol 2026) showed a sustained survival benefit with both regimens in PD-L1 ≥1% patients (HR 0.62).
The trial was open-label; nivolumab + ipilimumab showed no progression-free survival benefit; the benefit in the overall population (including low PD-L1) was smaller than in PD-L1 ≥1% patients; the primary endpoints were defined only in patients with tumour-cell PD-L1 ≥1%.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
Who are you reading this site as?
Your choice applies to every page; change it any time from the bottom of the page.
Type to search...