Solid Tumor, Non-small Cell Lung Cancer, Glioblastoma
A Study of Galunisertib (LY2157299) in Combination With Nivolumab in Advanced Refractory Solid Tumors and in Recurrent or Refractory NSCLC, Hepatocellular Carcinoma, or Glioblastoma
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), hepatocellular carcinoma (HCC) or glioblastoma.
Your participation in this trial could last up to 4 months depending on how you and your tumor respond.
Key Participation Requirements
All clinical trials have rules about who can participate. This section outlines some of those rules. Please contact a study center to discuss the full set of criteria
For the Phase 1b part of the trial, participants must have advanced refractory solid tumors in any line of therapy. For the Phase 2 part of the trial, participants must have recurrent or refractory NSCLC or HCC with elevated alpha-fetoprotein (AFP), or glioblastoma tumor type
Participants with NSCLC prior lines of therapy must include a platinum-based therapy
Participants with NSCLC must have completed neo-adjuvant or adjuvant therapy with a platinum doublet and have experienced disease recurrence within 6 months of completing the platinum doublet
Participants with HCC must have Child-Pugh A only
Participants with HCC must have had: one prior line of therapy which included sorafenib or have progressed or if not eligible for transarterial chemoembolization, were intolerant to sorafenib
Participants with HCC may have had sorafenib for locally advanced disease or are intolerant to sorafenib. Participants may have had clinical progression only following sorafenib or local therapy
Participants with Glioblastoma (GB) must have had previous first line of therapy with at least radiotherapy and temozolomide except for participants with O6-methylguanine-DNA methyltransferase (MGMT) unmethylated newly diagnosed GB. Participants with MGMT unmethylated newly diagnosed GB may have received radiation therapy only
Any participant must not have moderate or severe cardiovascular disease
Any participant must have adequate organ function
Any participant must use an approved contraceptive method