NCT04262427

The CAPER Trial: A Phase Ib Clinical Trial of Cyclophosphamide And PEmbrolizumab in Metastatic Renal Cell Carcinoma

The CAPER Study: A Phase Ib Clinical Trial of Cyclophosphamide And PEmbrolizumab in Metastatic Renal Cell Carcinoma (RCC) (CAPER Trial)

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: The Christie NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The CAPER Trial will be looking at patients with locally advanced (inoperable) or metastatic clear cell renal cell carcinoma who have had previous treatment with immunotherapy and have experienced disease progression. Immunotherapies aim to boost the body's natural defences to fight cancer, however the tumour micro-environment may significantly impact how effective this approach will be at reducing cancer growth and spread. The CAPER trial aims to evaluate whether oral metronomic cyclophosphamide (50mg once daily) can alter the tumour environment and ultimately lead to responses to pembrolizumab in patients who have failed prior immunotherapy. Patients who join the study will initially take cyclophosphamide 50mg tablets once a day for 21 days during the 'run-in period'. Following this, they will continue with cyclophosphamide 50mg daily alongside intravenous pembrolizumab treatment administered once every 3 weeks. Patients will continue both treatments until the occurrence of either disease progression, unexpected toxicity, patient withdrawal, or completion of 24 months of treatment. Patients will undergo CT scanning to evaluate response every 9 weeks during trial treatment. Research biopsies will be taken at baseline (prior to treatment), after the 21 day run-in period on oral cyclophosphamide, and at the time of the first CT scan (week 9 on treatment). Patients will also have additional research blood samples collected at serial timepoints whilst on treatment. The biopsy and blood samples will allow evaluation of the changes induced by cyclophosphamide and pembrolizumab within the tumour microenvironment as well as changes in circulating factors such as cytokines.

Conditions

• Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Cyclophosphamide 50mg	cytotoxic chemotherapy
DRUG	Pembrolizumab 25 mg/1 ML Intravenous Solution [KEYTRUDA]	potent humanized immunoglobulin (Ig) G4 monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD-1) receptor

Timeline

• Start date: 2021-04-28
• Primary completion: 2023-10-28
• Completion: 2024-04-28
• First posted: 2020-02-10
• Last updated: 2022-08-23

Locations

4 sites across 1 country: United Kingdom