NCT02423343

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

A Phase 1b/2 Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of a Novel Transforming Growth Factor-beta Receptor I Kinase Inhibitor (Galunisertib) Administered in Combination With Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors (Phase 1b) and in Recurrent or Refractory Non-small Cell Lung Cancer or Hepatocellular Carcinoma (Phase 2)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Solid Tumor
• Non-Small Cell Lung Cancer Recurrent
• Hepatocellular Carcinoma Recurrent

Interventions

Type	Name	Description
DRUG	Galunisertib	Administered orally
DRUG	Nivolumab	Administered IV

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-12-13
• Completion: 2020-07-08
• First posted: 2015-04-22
• Last updated: 2021-09-09
• Results posted: 2021-09-09

Locations

9 sites across 2 countries: United States, Spain