CheckMate 358
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.
Overview
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.
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