Phase 1b study of intravenous coxsackievirus A21 (V937) and ipilimumab for patients with metastatic uveal melanoma.

ABSTRACT:

Purpose

No standard of care therapy exists for patients with metastatic uveal melanoma who are not HLA-A2:01 positive. The phase 1b, open-label CLEVER study (NCT03408587) evaluated V937 in combination with ipilimumab in patients with uveal melanoma.

Methods

Adults with advanced uveal melanoma and liver metastases received up to 8 cycles of intravenous V937 (1 × 10⁹ TCID₅₀ per infusion; infusions on days 1, 3, 5, and 8 [cycle 1], then every 3 weeks [Q3W] thereafter [cycles 2-8]) and 4 cycles of intravenous ipilimumab 3 mg/kg Q3W (beginning at cycle 1 day 8). The primary endpoint was safety. Secondary endpoints included objective response rate and progression-free survival (PFS) per immune-related Response Evaluation Criteria in Solid Tumors (irRECIST).

SUBMITTER: Lutzky J 

PROVIDER: S-EPMC10356892 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature