At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 41 enrolled
Drug / intervention
Galunisertib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Galunisertib and Nivolumab for Solid Tumor and 2 related conditions. Completed, enrolled 41 participants across 9 sites in 2 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain, United States
CollaboratorsBristol-Myers Squibb
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJan 2015
First PostedApr 2015
Primary CompletionDec 2018
Study CompletionJul 2020
TodayJul 2026
First PostedApr 22, 2015
Enrollment StartJan 1, 2015
Primary CompletionDec 13, 2018
Study CompletionJul 8, 2020
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 11.2 years ago
Interventions
Galunisertibdrug
Administered orally
Nivolumabdrug
Administered IV