drugset / Trial / NCT04145193
Novel Oncology Therapies in Combination With Adjuvant Chemo in High-risk MSS-CRC
RandomizedSequentialOpen-labelTreatment
Summary
Columbia 2 is a Phase 2 platform study to evaluate the safety and efficacy of standard of care (FOLFOX) alone and in combination with novel oncology therapies in adjuvant high-risk microsatellite-stable colorectal cancer
Timeline
- Start
- 2020-10-01
- Primary completion
- 2024-03-19
- Completion
- 2024-03-19
Outcome
Outcome not reported
Stopped (Enrollment): “Study withdrawn prior to enrollment due to changing standard of care landscape.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |
| Subject | Monalizumab | Monoclonal antibody | 750 mg | Intravenous |
| Subject | Oleclumab | Monoclonal antibody | 3000 mg | Intravenous |
| Comparator | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Comparator | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Comparator | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |