Trials / Active Not Recruiting
Active Not RecruitingNCT04457284
Temozolomide, Cisplatin, and Nivolumab in People With Colorectal Cancer
A Phase II Study of Temozolomide, Cisplatin and Nivolumab in MMR-Proficient Colorectal Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 + |
Timeline
- Start date
- 2020-11-18
- Primary completion
- 2026-07-01
- Completion
- 2026-07-01
- First posted
- 2020-07-07
- Last updated
- 2026-03-13
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04457284. Inclusion in this directory is not an endorsement.