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NCT04262427: CAPER

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

Status unknown Phase 1, PHASE2 Last updated 23 August 2022
What this trial tests

Phase 1, PHASE2 trial testing Cyclophosphamide 50mg in Metastatic Renal Cell Carcinoma in 21 participants. Status unknown.

Timeline
28 April 2021
Primary endpoint
28 October 2023
28 April 2024

Quick facts

Lead sponsorThe Christie NHS Foundation Trust
PhasePhase 1, PHASE2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment21
Start date28 April 2021
Primary completion28 October 2023
Estimated completion28 April 2024
Sites4 locations across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

The Christie NHS Foundation Trust

Who can join

18 and older, any sex, with Metastatic Renal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The Frontline Immunotherapy-Based Treatment of Advanced Clear Cell Renal Cell Carcinoma: Current Evidence and Clinical Perspective.
    Kim IH, Lee HJ. · · 2022 · cited 18× · PMID 35203461 · DOI 10.3390/biomedicines10020251
  2. PD-1/PD-L1 inhibitors-based treatment for advanced renal cell carcinoma: Mechanisms affecting efficacy and combination therapies.
    Ding L, Dong HY, Zhou TR, Wang YH, et al · · 2021 · cited 15× · PMID 34382349 · DOI 10.1002/cam4.4190
  3. Effect of systemic therapies or best supportive care after disease progression to both nivolumab and cabozantinib in metastatic renal cell carcinoma: The Meet-Uro 19BEYOND study.
    Roviello G, Gambale E, Giorgione R, Santini D, et al · · 2022 · cited 3× · PMID 35312175 · DOI 10.1002/cam4.4681

Verify or expand the search:

Other trials of Cyclophosphamide 50mg

Trials testing the same drug.

Other recruiting trials for Metastatic Renal Cell Carcinoma

Currently open trials in the same condition.

Other The Christie NHS Foundation Trust trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04262427.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing