drugset
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

Outcome

Outcome not reported

Stopped: “Based on the totality of the generated combined safety and efficacy data in the interim period, the company decided to terminate the combination study in NSCLC patients. There are no subjects on study drug at this time or in the EOT Follow-up period.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody — Intravenous
Subject grapiprant Small molecule — Oral

Indications

lung adenocarcinoma