Clinical trialPhase 3Kidney cancer

Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: final analysis of efficacy and safety from the phase III CheckMate 214 trial

Ann Oncol · 20261096 patients

Choueiri TK, Albigès L, McDermott DF, Hammers HJ, Escudier B, Burotto M, et al. Ann Oncol. 2026. 37:960-973

Study type: Clinical trial
Study name: CheckMate 214
Phase: Phase 3
Design: Open-label randomised trial (final analysis with a median follow-up of 9.3 years)
Sample size: 1096 patients
Source: Ann Oncol · 2026
Trial registration: NCT02231749

In plain words

In this large trial, a combination of two immunotherapy drugs (nivolumab and ipilimumab) was compared with sunitinib tablets. After more than 9 years, about 30% of patients in the combination group versus about 19% in the sunitinib group were alive, and many responses lasted for years.

Key results

HR 0.69

Overall survival (intermediate/poor risk)

95% CI 0.59–0.81; 108-month survival 30.2% vs 18.7%

HR 0.71

Overall survival (all patients)

0.62–0.82; 108-month survival 31.4% vs 19.5%

HR 0.80

Overall survival (favourable risk)

0.59–1.09; 108-month survival 35.3% vs 21.8%

25.4% vs 8.5%

96-month progression-free survival (intermediate/poor risk)

48.0% vs 19.0%

Durability of response to 96 months (all patients)

48.6% vs 64.1%

Grade 3–4 treatment-related adverse events

Drugs in this study:Nivolumab (Opdivo)Ipilimumab (Yervoy)

Dose and schedule cards

Nivolumab + ipilimumab (CheckMate 214)

Advanced RCC, first line, IMDC intermediate or poor risk; SITC-preferred option for tumours with sarcomatoid featuresOn the page “Kidney cancer” · First-line regimens for advanced RCC

Advanced RCC, first line, IMDC intermediate or poor risk; SITC-preferred option for tumours with sarcomatoid features

Drug	Dose	Route	Schedule
Induction
Nivolumab	3 mg/kg	IV, 30-minute infusion (nivolumab first, then ipilimumab on the same day)	Day 1 every 3 weeks, 4 doses
Ipilimumab	1 mg/kg	IV, 30-minute infusion	Day 1 every 3 weeks, 4 doses
Maintenance
Nivolumab	240 mg (or 480 mg)	IV, 30-minute infusion	Every 2 weeks (480 mg dose: every 4 weeks)

Cycle length: Induction: every 21 days × 4; maintenance: every 14 or 28 days
Duration: 4 combination doses, then nivolumab monotherapy until progression or unacceptable toxicity

Per the FDA labels and the trial. Dose reduction of ipilimumab is not recommended; for toxicity, both drugs are withheld or permanently discontinued together. This combination should be given in experienced centres with the support of a multidisciplinary team.

On the page “Kidney cancer” · First-line regimens for advanced RCC

Advanced intermediate- or poor-risk renal cell carcinoma (CheckMate 214)

First lineOn the page “Ipilimumab (Yervoy)” · Other cancers, with nivolumab (FDA label, revised 08/2026)

First line

Drug	Dose	Route	Schedule
Combination: 4 doses
Nivolumab	3 mg/kg	IV, 30-minute infusion	Day 1 every 3 weeks (given first)
Ipilimumab	1 mg/kg	IV, 30-minute infusion	Same day, after nivolumab
Maintenance
Nivolumab	240 mg every 2 weeks or 480 mg every 4 weeks	IV, 30-minute infusion	After the 4 combination doses

Cycle length: 21 days, then 14 or 28 days
Duration: Combination 4 doses; nivolumab until progression or unacceptable toxicity

On the page “Ipilimumab (Yervoy)” · Other cancers, with nivolumab (FDA label, revised 08/2026)

Nivolumab + ipilimumab

Intermediate- and poor-risk advanced kidney cancerOn the page “Immunotherapy regimens in kidney cancer: pembrolizumab-axitinib, nivolumab-ipilimumab and adjuvant pembrolizumab”

Intermediate- and poor-risk advanced kidney cancer

Drug	Dose	Route	Schedule
Phase 1: 4 cycles
Nivolumab	3 mg/kg	IV	Day 1
Ipilimumab	1 mg/kg	IV	Day 1
Phase 2
Nivolumab	240 mg every 2 weeks or 480 mg every 4 weeks	IV	Day 1

Cycle length: Combination every 21 days; then nivolumab alone
Duration: Until progression

As in CheckMate 214.

Dose source:.

On the page “Immunotherapy regimens in kidney cancer: pembrolizumab-axitinib, nivolumab-ipilimumab and adjuvant pembrolizumab”

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.

Treatment arms and regimens

1Nivolumab + ipilimumab

Induction: nivolumab 3 mg/kg IV (60-minute infusion) + ipilimumab 1 mg/kg IV (30-minute infusion) every 3 weeks for 4 doses. Maintenance: nivolumab 3 mg/kg every 2 weeks (in this report: either 240 mg every 2 weeks or 480 mg every 4 weeks) until progression or unacceptable toxicity. Dose reductions of nivolumab and ipilimumab were not allowed; dose delays for adverse events were allowed.

2Sunitinib

Sunitinib 50 mg orally once daily for 4 weeks followed by 2 weeks off (6-week cycle), until progression or unacceptable toxicity; dose reductions were allowed.

Source of the regimen details: Abstract of the paper (PubMed), full text of the original CheckMate 214 paper (NEJM 2018; PMC5972549) and ClinicalTrials.gov NCT02231749

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.

Study population

Adults with advanced or metastatic renal-cell carcinoma with a clear-cell component, no prior systemic therapy, measurable disease per RECIST 1.1 and Karnofsky performance status of at least 70; patients with brain metastases, autoimmune disease or use of corticosteroids/immunosuppressants were excluded. The primary endpoints were assessed in patients with IMDC intermediate or poor risk (847 patients).

Endpoints

Overall survival, and progression-free survival and objective response by independent radiology review committee, in IMDC intermediate/poor-risk patients (primary), in all patients (secondary) and in favourable-risk patients (exploratory).

Safety and side effects

Treatment-related adverse events of any grade occurred in 94.1% with nivolumab + ipilimumab vs 97.6% with sunitinib, and grade 3–4 events in 48.6% and 64.1%, respectively.

Clinical significance and place in guidelines

The final analysis confirms the long-term survival benefit in intermediate/poor risk; in favourable risk the HR for overall survival was 0.80, but the confidence interval crosses 1. This combination is one of the four first-line regimens recommended in guidelines.

Limitations

The trial is open-label; the favourable-risk analyses are exploratory and the post hoc analyses are descriptive.

Original article (DOI)PubMed ClinicalTrials.gov

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.