drugset / Trial / NCT03696212

Grapiprant (ARY-007) and Pembrolizumab in Patients With Advanced or Metastatic Post-PD-1/L1 NSCLC Adenocarcinoma

NCT03696212

Phase 1/2 Terminated 18 enrolled Arrys Therapeutics Merck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelTreatment

Summary

This study will be conducted in adult participants diagnosed with NSCLC who have been previously treated for a minimum of 12 weeks with any PD-1 or PD-L1 checkpoint inhibitor. This is a phase 1b/2, multi-center, open label study designed to assess safety and tolerability of grapiprant in combination with pembrolizumab, to determine the recommended phase 2 dose (RP2D) with pembrolizumab, and to evaluate disease response with grapiprant based on investigator assessments. Pharmacokinetics, pharmacodynamics and response biomarkers will also be assessed.

Timeline

Start
2019-01-08
Primary completion
2021-02-15
Completion
2021-02-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody Intravenous
Subject grapiprant Small molecule Oral

Indications