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Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Chinese Participants With Stage IV Colorectal Cancer (MK-3475-C66)

NCT05239741 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-22

No results posted yet for this study

Summary

In this study, Chinese participants with MSI-H or dMMR advanced colorectal cancer will be assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of care (SOC) chemotherapy regimens for treatment. There is no hypothesis testing for this study.

Conditions

  • Colorectal Neoplasms

Interventions

BIOLOGICAL

Pembrolizumab

Intravenous (IV) infusion

DRUG

Oxaliplatin

85 mg/m\^2 given as an intravenous infusion (IV) on Day 1 in each 14-day cycle (Q2W) as part of the mFOLFOX6 regimen

DRUG

Leucovorin

400 mg/m\^2 given as an IV on Day 1 Q2W as part of the mFOLFOX6 and FOLFIRI regimens

DRUG

5-fluorouracil

400 mg/m\^2 given as an IV bolus on Day 1 and then 1200 mg/m\^2/day IV over 2 days for a total dose of 2400 mg/m\^2 Q2W as part of the mFOLFOX6 and FOLFIRI regimens

DRUG

Irinotecan

180 mg/m\^2 IV on Day 1 Q2W as part of the FOLFIRI regimen

BIOLOGICAL

Bevacizumab

IV infusion

BIOLOGICAL

Cetuximab

IV infusion

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-02
Primary Completion
2028-09-19
Completion
2028-09-19
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05239741 on ClinicalTrials.gov