drugset / Trial / NCT05407675

A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors

NCT05407675

Phase 1/2 Completed 68 enrolled Bristol-Myers Squibb
Non-randomizedSequentialOpen-labelTreatment

Summary

The primary purpose of this study is to characterize the safety profile of BMS-986408 as monotherapy and in combination with nivolumab or nivolumab and ipilimumab to establish the maximum tolerated dose (MTD). The Recommended Phase 2 Dose (RP2D) that optimizes the pharmacokinetic/pharmacodynamic (PK/PD) relationship of BMS-986408 will also be determined.

Timeline

Start
2022-08-02
Primary completion
2024-08-22
Completion
2025-07-24

Drugs

EvaluationDrugModalityDoseRoute
Subject BMS-986408 Unknown
Subject Ipilimumab Monoclonal antibody
Subject Nivolumab Monoclonal antibody
Subject Rabeprazole Small molecule
Background Cisplatin Other / unclassified
Background Paclitaxel Small molecule
Background Pemetrexed Small molecule
Background carbplatin Unknown

Indications