A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)

Phase 2 Completed 212 enrolled Bristol-Myers Squibb

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to demonstrate the clinical activity of nivolumab in combination with ipilimumab in multiple types of tumors based on their Tumor Mutational Burden status.

Timeline

Start: 2018-10-31
Primary completion: 2022-05-03
Completion: 2023-08-02

Publications

Schenker M, Burotto M, Richardet M, Ciuleanu TE, Goncalves A, Steeghs N, Schoffski P, Ascierto PA, Maio M, Lugowska I, Lupinacci L, Leary A, Delord JP, Grasselli J, Tan DSP, Friedmann J, Vuky J, Tschaika M, Konduru S, Vemula SV, Slepetis R, Kollia G, Pacius M, Duong Q, Huang N, Doshi P, Baden J, Di Nicola M. Randomized, open-label, phase 2 study of nivolumab plus ipilimumab or nivolumab monotherapy in patients with advanced or metastatic solid tumors of high tumor mutational burden. J Immunother Cancer. 2024 Aug 6;12(8):e008872. doi: 10.1136/jitc-2024-008872.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ipilimumab	Monoclonal antibody	—	—
Subject	Nivolumab	Monoclonal antibody	—	—

Indications

No indication recorded.