NCT03696212

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

Open Label, Single Arm, Phase 1b/2 Study to Evaluate the Safety and Efficacy of Grapiprant (ARY-007) in Combination With Pembrolizumab in Patients With Advanced or Metastatic Post-PD-1/L1 Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Arrys Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer Adenocarcinoma

Interventions

Type	Name	Description
DRUG	grapiprant and pembrolizumab	Participants will be administered 21-day cycles of oral grapiprant in combination with IV pembrolizumab

Timeline

• Start date: 2019-01-08
• Primary completion: 2021-02-15
• Completion: 2021-02-15
• First posted: 2018-10-04
• Last updated: 2021-02-21

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study