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A Phase II Study of Temozolomide, Cisplatin and Nivolumab in MMR-Proficient Colorectal Cancer
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.
Details
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 18 |
| Start date | 2020-11-18 |
| Completion | 2026-07 |
Conditions
- Colorectal Adenocarcinoma
Interventions
- Temozolomide (TMZ)
- Cisplatin
- Nivolumab
Primary outcomes
- Response — 1 year
will be evaluated in this study using the new international criteria proposed in RECIST 1.1 \[Eur J Ca 45:228-247, 2009\]. Changes in the largest diameter (unidimensional measurement) of the tumor and the shortest diameter of malignant lymph nodes are used with the RECIST criteria.
Countries
United States