Ignite Creation Date:
2024-05-06 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03658772
Status:
COMPLETED
Last Update Posted:
2023-10-24
First Post:
2018-08-24
Brief Title:
Grapiprant and Pembrolizumab in Patients With Advanced or Progressive MSS Colorectal Cancer
Sponsor:
Arrys Therapeutics
Organization:
Arrys Therapeutics
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Keynote-878 | OTHER | Merck Sharp Dohme Corp | None |