Pembrolizumab/Quavonlimab for Colorectal Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Colorectal CancerPembrolizumab/Quavonlimab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effectiveness and safety of co-formulated pembrolizumab/quavonlimab with other treatments for people with MSI-H or dMMR metastatic stage IV colorectal cancer.

Eligible Conditions
  • Colorectal Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Up to approximately 50 months

Month 24
Therapeutic procedure
Month 27
Number of participants who experienced an Adverse Event (AE)
Month 50
DOR per RECIST 1.1 as assessed by Investigator
Duration of Response (DOR) per RECIST 1.1 as assessed by BICR
Number of Participants Discontinuing Study Treatment Due to an AE
Number of Participants Who Experienced an Adverse Event (AE)
ORR per RECIST 1.1 as assessed by Investigator
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR)
Overall Survival (OS)
PFS per RECIST 1.1 as assessed by Investigator
Progression-Free Survival (PFS) per RECIST 1.1 as assessed by BICR

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

5 Treatment Groups

Pembrolizumab
1 of 5
Pembrolizumab Plus MK-4830
1 of 5
Pembrolizumab/Vibostolimab
1 of 5
Pembrolizumab/Quavonlimab
1 of 5
Pembrolizumab/Favezelimab
1 of 5

Active Control

Experimental Treatment

320 Total Participants · 5 Treatment Groups

Primary Treatment: Pembrolizumab/Quavonlimab · No Placebo Group · Phase 2

Pembrolizumab Plus MK-4830Experimental Group · 2 Interventions: Pembrolizumab, MK-4830 · Intervention Types: Biological, Biological
Pembrolizumab/Vibostolimab
Biological
Experimental Group · 1 Intervention: Pembrolizumab/Vibostolimab · Intervention Types: Biological
Pembrolizumab/Quavonlimab
Biological
Experimental Group · 1 Intervention: Pembrolizumab/Quavonlimab · Intervention Types: Biological
Pembrolizumab/Favezelimab
Biological
Experimental Group · 1 Intervention: Pembrolizumab/Favezelimab · Intervention Types: Biological
Pembrolizumab
Biological
ActiveComparator Group · 1 Intervention: Pembrolizumab · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 50 months

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,681 Previous Clinical Trials
4,957,132 Total Patients Enrolled
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,578,027 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,638 Previous Clinical Trials
7,941,657 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are receiving capecitabine, irinotecan and oxaliplatin.
You have a histologically confirmed diagnosis of Stage IV CRC.
You have a life expectancy of at least 3 months.
You have measurable disease per RECIST 1.1 as assessed by the site and verified by BICR.
A tumor tissue sample must be obtained from a tissue sample that has not been previously irradiated.
You have a disease that is not responsive to treatment with anti-VEGF monoclonal antibodies.
You have locally confirmed dMMR/MSI-H.
You have been treated with EGFR inhibitors (cetuximab or panitumumab) for a solid tumor and are eligible for this study if you have left sided tumors.

Who else is applying?

What state do they live in?
Nova Scotia100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
The Moncton Hospital-Oncology ( Site 0307)100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%