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

Phase 1
Waitlist Available
Research Sponsored by Arrys Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years from start of study drug.
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug combination of grapiprant and pembrolizumab in adults with advanced colorectal cancer that hasn't responded to other treatments. The goal is to see if this combination can safely and effectively stop cancer growth and help the immune system fight the disease.

Eligible Conditions
  • Colorectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from start of study drug.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years from start of study drug. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Define the recommended phase 2 dose (RP2D) of grapiprant combined with pembrolizumab
Safety and tolerability of grapiprant alone and in combination with pembrolizumab
Secondary study objectives
Apparent oral clearance (CL/F)
Disease control rate (DCR)
Duration of Response (DOR)
+12 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment1 Intervention
Participants will be treated with grapiprant in combination with pembrolizumab.
Group II: Cohort 1Experimental Treatment2 Interventions
Single Agent run-in with grapiprant and then combination treatment of grapiprant and pembrolizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
grapiprant and pembrolizumab
2018
Completed Phase 1
~60
grapiprant
2018
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
4,027 Previous Clinical Trials
5,188,749 Total Patients Enrolled
Arrys TherapeuticsLead Sponsor
1 Previous Clinical Trials
18 Total Patients Enrolled
Jason Sager, MDStudy DirectorArrys Therapeutics
2 Previous Clinical Trials
96 Total Patients Enrolled
Sergio Santillana, MDStudy DirectorIkena Oncology
~7 spots leftby Dec 2025
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