An Adaptive Study to Match Patients With Solid Tumors to Various Immunotherapy Combinations Based Upon a Broad Biomarker Assessment

Phase 1 Completed 20 enrolled Bristol-Myers Squibb

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the treatment of solid tumors with various immunotherapy combinations. The treatment will be determined based upon a broad biomarker assessment.

Timeline

Start: 2018-05-07
Primary completion: 2021-03-31
Completion: 2021-08-25

Outcome

Met primary endpoint

paper 20/23 (87%) of eligible patients were successfully allocated and started on treatment within the 12-day window, meeting the primary endpoint. PMID 40389374 ↗

Publications

Luke JJ, Bever K, Hodi FS, Taube J, Massey A, Yao D, Neely J, Tam R, Lee G, Gupta A, Dutta S, Szabo P, Bao R, Reilly T. Rationale and feasibility of a rapid integral biomarker program that informs immune-oncology clinical trials: the ADVISE trial. J Immunother Cancer. 2025 May 19;13(5):e011170. doi: 10.1136/jitc-2024-011170.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cabiralizumab	Monoclonal antibody	—	—
Subject	Ipilimumab	Monoclonal antibody	—	—
Subject	LINRODOSTAT	Small molecule	—	—
Subject	Nivolumab	Monoclonal antibody	—	—
Subject	Relatlimab	Monoclonal antibody	—	—