# CheckMate 358

Source: https://onco.cc/trials/checkmate-358/  
OnCo record `checkmate-358` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

CheckMate 358 gave the immunotherapy drug nivolumab to people with cancers caused by viruses; in Merkel cell carcinoma, a short course before surgery made the tumour disappear entirely in nearly half of those operated on, the first sign that immunotherapy could work before surgery in this skin cancer.

## Summary

CheckMate 358 was a non-comparative open-label phase 1/2 programme in advanced cancers linked to viruses, including Merkel cell carcinoma (Merkel cell polyomavirus), cervical, vaginal and vulvar cancers and HPV-positive head and neck cancer (human papillomavirus), EBV-positive gastric cancer and nasopharyngeal cancer. Cohorts received nivolumab alone or combined with ipilimumab, relatlimab or daratumumab.

The most influential cohort gave two doses of nivolumab before surgery to patients with resectable Merkel cell carcinoma; a substantial share of those who underwent surgery had a pathological complete response, and these responses were durable. The cervical cohort showed activity for nivolumab in recurrent or metastatic disease. The Merkel results underpin the ongoing randomised trials of perioperative immunotherapy in this cancer.

## Fields

- Kind: Trial
- Status: completed
- Last checked: 2026-09-17
- Tags: subtype-trials
- Registry id: NCT02488759
- Phase: 1/2
- Setting: Virus-associated cancers, including Merkel cell carcinoma, cervical, vaginal and vulvar cancers, HPV-positive head and neck cancer, EBV-positive gastric cancer and nasopharyngeal cancer: nivolumab alone or with ipilimumab or other agents, with a neoadjuvant Merkel cell cohort
- Sponsor: Bristol Myers Squibb
- Enrolled: 578
- Result: Neoadjuvant nivolumab produced pathological complete responses in a substantial share of resectable Merkel cell carcinomas, with durable responses; nivolumab also showed activity in recurrent cervical cancer.

## Sources

- ClinicalTrials.gov NCT02488759: https://clinicaltrials.gov/study/NCT02488759

## Connected records

- cancers: [Cervical cancer](https://onco.cc/cancers/cervical/), [Merkel cell carcinoma](https://onco.cc/cancers/merkel-cell-carcinoma/), [Recurrent or metastatic cervical cancer](https://onco.cc/cancers/recurrent-metastatic-cervical-cancer/), [Skin cancer (all types)](https://onco.cc/cancers/skin-cancer/)
- drugs: [Ipilimumab](https://onco.cc/drugs/ipilimumab/), [Nivolumab](https://onco.cc/drugs/nivolumab/)
- companies: [Bristol Myers Squibb](https://onco.cc/companies/bms/)
- people: [Sandra P. D'Angelo](https://onco.cc/people/sandra-dangelo/)

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JSON: https://onco.cc/api/v1/entities/checkmate-358.json