Clinical Trials Search
Clinical Trial 18537
Interventions:BMS-936558 (Nivolumab); Galunisertib; LY2157299 (Galunisertib); Nivolumab
Study Type: Treatment
Phase of Study: Phase I/II
- Scott Antonia
A Phase 1b/2 Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of a Novel Transforming Growth Factor-B Receptor I Kinase Inhibitor (Galunisertib) Administered in Combination with Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumours (Phase 1b) and in Recurrent or Refractory Non-Small Cell Lung Cancer or Hepatocellular Carcinoma (Phase 2)
The main purpose of this study is to help answer the following research questions: Which dose of galunisertib plus nivolumab is safe to give to participants with advanced solid tumors. Which dose of galunisertib plus nivolumab is safe to give to participants with lung cancer, liver cancer, or brain cancer, who did not respond to previous treatment.
The primary objective of the Phase 1b part of this study is to assess the safety and tolerability of orally dosed galunisertib 14 days on/14 days off in combination with IV nivolumab 3 mg/kg Q2W by identifying dose-limiting toxicities (DLTs) and the maximum tolerated dose (MTD) or pharmacologically active dose (PAD) of the combination in patients with advanced refractory solid tumours during the first 2 cycles. The primary objective of the Phase 2 part (expansion cohorts) of this study is to assess the safety of the combination of galunisertib and nivolumab in patients with refractory or recurrent NSCLC, HCC, or glioblastoma who have failed 1 prior line of therapy.