A Study of Galunisertib (LY2157299) in Combination With Nivolumab in Advanced Refractory Solid Tumors and in Recurrent or Refractory NSCLC, or Hepatocellular Carcinoma

Phase 1/2 Completed 41 enrolled Eli Lilly and Company Bristol-Myers Squibb · collab

Non-randomizedSequentialOpen-labelTreatment

Summary

The main purpose of this study is to evaluate the safety, tolerability, and efficacy of the study drug known as galunisertib in combination with nivolumab in participants with advanced refractory solid tumors and in recurrent or refractory non-small cell lung cancer (NSCLC) or hepatocellular carcinoma (HCC).

Timeline

Start: 2015-01-01
Primary completion: 2018-12-13
Completion: 2020-07-08

Outcome

Met primary endpoint

paper The study met its primary endpoint as galunisertib combined with nivolumab was well tolerated. PMID 37507657 ↗

Publications

Nadal E, Saleh M, Aix SP, Ochoa-de-Olza M, Patel SP, Antonia S, Zhao Y, Gueorguieva I, Man M, Estrem ST, Liu J, Avsar E, Lin WH, Benhadji KA, Gandhi L, Guba SC, Diaz IA. A phase Ib/II study of galunisertib in combination with nivolumab in solid tumors and non-small cell lung cancer. BMC Cancer. 2023 Jul 28;23(1):708. doi: 10.1186/s12885-023-11153-1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Galunisertib	Small molecule	50 mg	Oral
Subject	Galunisertib	Small molecule	80 mg	Oral
Subject	Galunisertib	Small molecule	150 mg	Oral
Subject	Nivolumab	Monoclonal antibody	3 mg/kg	Intravenous