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grapiprant and pembrolizumab for 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

Summary

This study is evaluating whether a combination of a drug and a white blood cell may help treat colorectal cancer.

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

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

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

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
3,919 Previous Clinical Trials
5,068,209 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
~8 spots leftby Jul 2025