Spots Global Cancer Trial Database for Grapiprant and Pembrolizumab in Patients With Advanced or Progressive MSS Colorectal Cancer

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Trial Identification

Brief Title: Grapiprant and Pembrolizumab in Patients With Advanced or Progressive MSS Colorectal Cancer

Official Title: An Open-label, Single-arm, Phase 1b Study to Evaluate the Safety and Efficacy of Grapiprant (ARY-007) in Combination With Pembolizumab in Patients With Advanced or Progressive Microsatellite Stable (MSS) Colorectal Cancer (CRC)

Study ID: NCT03658772

Conditions

Microsatellite Stable Colorectal Cancer

Interventions

grapiprant

grapiprant and pembrolizumab

Study Description

Brief Summary: This study will be conducted in adult participants diagnosed with any form of an advanced or progressive MSS CRC for which 1st and 2nd line standard therapy (at least one of which contained fluorouracil) is no longer effective or is intolerable. This is a phase 1b, 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 and characterize the PK of grapiprant alone and in combination with pembrolizumab. Disease response, pharmacodynamics, and response biomarkers will also be assessed.

Detailed Description: