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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

Study 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%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
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
3,884 Previous Clinical Trials
5,054,332 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
GastroenterologyJournal
Cyclooxygenases and Prostaglandins in Tumor Immunology and Microenvironment of Gastrointestinal Cancer
Wang, Dingzhi, Carlos S. Cabalag, Nicholas J. Clemons, and Raymond N. DuBois. 2021. “Cyclooxygenases and Prostaglandins in Tumor Immunology and Microenvironment of Gastrointestinal Cancer”. Gastroenterology. Elsevier BV. doi:10.1053/j.gastro.2021.09.059.
clinicaltrials.govStudy
Grapiprant and Pembrolizumab in Patients With Advanced or Progressive MSS Colorectal Cancer
2018. "Grapiprant and Pembrolizumab in Patients With Advanced or Progressive MSS Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03658772.
~8 spots leftby Apr 2025
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