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Temozolomide, Cisplatin, and Nivolumab in People With Colorectal Cancer

NCT04457284 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-03-13

No results posted yet for this study

Summary

This study will test whether the combination of cisplatin, nivolumab, and temozolomide is an effective treatment for in people with advanced and/or metastatic colorectal cancer that is mismatch repair-proficient (MMR-proficient). The researchers will also look at how safe the study drug combination is in participants.

Conditions

  • Colorectal Adenocarcinoma

Interventions

DRUG

Temozolomide (TMZ)

TMZ 150 mg/m2 Day 1 - 5 Q4W PO Cycle 1 TMZ 200 mg/m2 Day 1 - 5 Q4W PO Cycle 2 +

DRUG

Cisplatin

Cisplatin 40 mg/m2 Q2W IV infusion Cycle 1 +

DRUG

Nivolumab

Nivolumab 480 mg Q4W IV infusion Cycle 1 +

Sponsors & Collaborators

Principal Investigators

  • Neil Segal, MD, PhD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-18
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

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 NCT04457284 on ClinicalTrials.gov