drugset / Trial / NCT04262427
The CAPER Trial: A Phase Ib Clinical Trial of Cyclophosphamide And PEmbrolizumab in Metastatic Renal Cell Carcinoma
Phase 1/2
Unknown
21 enrolled
The Christie NHS Foundation Trust
Merck Sharp & Dohme LLC · collabUniversity of Liverpool · collabUniversity of Manchester · collab
NaSingle-groupOpen-labelTreatment
Summary
This is an open label investigator initiated Phase Ib study of combination pembrolizumab (Keytruda), 200mg IV 3 weekly (Q3W) with 50mg oral cyclophosphamide daily (OD) in metastatic renal cell carcinoma patients. 21 patients will be recruited within the United Kingdom (UK) will to examine the efficacy of the combination for up to 35 administrations (2 years). This study will be conducted in compliance with Good Clinical Practice (GCP) and all relevant regulations.
Timeline
- Start
- 2021-04-28
- Primary completion
- 2023-10-28
- Completion
- 2024-04-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 50 mg | Oral |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |