Dose-escalation Study of Birinapant and Pembrolizumab in Solid Tumors

Summary

An ascending dose study in patients with solid tumors to evaluate the safety, tolerability, pharmacodynamics and efficacy of birinapant when given in combination with pembrolizumab. A dose expansion phase of 4 cohorts will also be included.

Timeline

Start

2017-08-04

Primary completion

2020-02-17

Completion

2020-02-17

Outcome

Missed primary endpoint

Stopped (Enrollment): “Based on a futility analysis, the data monitoring committee recommended to stop enrollment.”

release “phase II study of combination therapy with birinapant and pembrolizumab (Keytruda®) indicated that the study's goals would not be achieved.” medivir.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Birinapant	Small molecule	5.6 mg/m2	Intravenous
Subject	Birinapant	Small molecule	11 mg/m2	Intravenous
Subject	Birinapant	Small molecule	17 mg/m2	Intravenous
Subject	Birinapant	Small molecule	22 mg/m2	Intravenous
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous

Indications