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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.
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.
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.
578 enrolled.
95% CI 38.7 to 78.9 · 95% CI 42.1 to 73
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Objective response, recurrent or metastatic Merkel cell carcinoma cohortprimary | Nivolumab | 25 | 60% | - | - | link |
| Nivolumab + ipilimumab | 43 | 58% | ||||
| Duration of response, Merkel cell carcinoma cohort | Nivolumab | 25 | 60.6 months | - | - | link |
| Nivolumab + ipilimumab | 43 | 25.9 months | ||||
| Progression-free survival, Merkel cell carcinoma cohort | Nivolumab | 25 | 21.3 months | - | - | link |
| Nivolumab + ipilimumab | 43 | 8.4 months | ||||
| Overall survival, Merkel cell carcinoma cohort | Nivolumab | 25 | 80.7 months | - | - | link |
| Nivolumab + ipilimumab | 43 | 29.8 months | ||||
| Grade 3-4 treatment-related adverse events, Merkel cell carcinoma cohort | Nivolumab | 25 | 28% | - | - | link |
| Nivolumab + ipilimumab | 43 | 47% |
Shares Bristol Myers Squibb, Nivolumab, Immune checkpoint inhibitors and the tag subtype-trials.
Shares Bristol Myers Squibb, Nivolumab, Immune checkpoint inhibitors and the tag subtype-trials.
Shares Merkel cell carcinoma, Skin cancer (all types), Immune checkpoint inhibitors and the tag subtype-trials.
Shares Ipilimumab, Bristol Myers Squibb, Nivolumab, Immune checkpoint inhibitors and the tag subtype-trials.
Shares Ipilimumab, Bristol Myers Squibb, Nivolumab, Immune checkpoint inhibitors and the tag subtype-trials.
Shares Cervical cancer, Immune checkpoint inhibitors and the tag subtype-trials.
Shares Bristol Myers Squibb and the tag subtype-trials.
Shares Bristol Myers Squibb and the tag subtype-trials.