A Trial Evaluating the Safety & Efficacy of Intra-Tumoral Ipilimumab in Combination With Intra-venous Nivolumab in Patients With Metastatic Melanoma

Phase 1/2 Completed 90 enrolled Gustave Roussy, Cancer Campus, Grand Paris

RandomizedParallel-groupOpen-labelTreatment

Summary

The study aims to evaluate the 6 month-treatment tolerance defined as the immune related grade 3-4 adverse event-free survival of the combination therapy IT ipilimumab + IV nivolumab. The IV ipilimumab + IV nivolumab (same doses than in Phase I) arm will be used as an internal control to interpret the results obtained in the IT ipilimumab arm.

Timeline

Start: 2016-12-05
Primary completion: 2021-01
Completion: 2022-05-20

Outcome

Met primary endpoint

paper The primary end-point was met PMID 42056527 ↗

Publications

Tselikas L, Susini S, Texier M, Yurchenko A, Routier E, Amini-Adle M, Tihic E, Mouraud S, Danlos FX, Ammari S, Raoult T, Roy S, Bredel D, Farhane S, Cassard L, Molinaro I, Eggermont A, Soria JC, Zitvogel L, Massard C, Paci A, de Baere T, Scoazec JY, Chaput N, Nikolaev S, Meyer N, Lebbe C, Dalle S, Robert C, Marabelle A. Safety and efficacy of intratumoural anti-CTLA4 with intravenous anti-PD1. Nature. 2026 Jul;655(8121):219-229. doi: 10.1038/s41586-026-10341-w. Epub 2026 Apr 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ipilimumab	Monoclonal antibody	0.3 mg/kg	Other
Subject	Ipilimumab	Monoclonal antibody	3 mg/kg	Other
Subject	Nivolumab	Monoclonal antibody	1 mg/kg	Intravenous
Subject	Nivolumab	Monoclonal antibody	3 mg/kg	Intravenous