drugset / Trial / NCT03626922
Study of Pembrolizumab With Pemetrexed and Oxaliplatin in Chemo-Refractory Metastatic Colorectal Cancer Patients
Phase 1
Unknown
33 enrolled
NSABP Foundation Inc
Eli Lilly and Company · collabMerck Sharp & Dohme LLC · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase Ib study to evaluate the safety and preliminary anti-tumor activity of pembrolizumab in combination with pemetrexed with or without oxaliplatin in patients with chemo-refractory microsatellite stable (MSS) metastatic colorectal cancer (mCRC) without any further standard treatment options.
Timeline
- Start
- 2019-05-15
- Primary completion
- 2021-10-31
- Completion
- 2022-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 120 mg/m2 | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | 4 mg | Oral |