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NCT04262427: CAPER
The CAPER Trial: A Phase Ib Clinical Trial of Cyclophosphamide And PEmbrolizumab in Metastatic Renal Cell Carcinoma
Phase 1, PHASE2 trial testing Cyclophosphamide 50mg in Metastatic Renal Cell Carcinoma in 21 participants. Status unknown.
28 October 2023
Quick facts
| Lead sponsor | The Christie NHS Foundation Trust |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 21 |
| Start date | 28 April 2021 |
| Primary completion | 28 October 2023 |
| Estimated completion | 28 April 2024 |
| Sites | 4 locations across United Kingdom |
Drugs / interventions tested
- Cyclophosphamide 50mg — full drug profile →
- Pembrolizumab 25 mg/1 ML Intravenous Solution [KEYTRUDA] — full drug profile →
Conditions studied
- Metastatic Renal Cell Carcinoma — all drugs for Metastatic Renal Cell Carcinoma →
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):
-
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 -
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 -
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:
- PubMed search for NCT04262427
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Metastatic Renal Cell Carcinoma
Currently open trials in the same condition.
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- NCT07123090 — A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma · Phase 2 · recruiting
- NCT06391099 — Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic · NA · recruiting
- NCT06500455 — Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to · Phase 3 · recruiting
Other The Christie NHS Foundation Trust trials
Trials by the same sponsor.
- NCT07183267 — Using Red Light Therapy to Ease Skin Side Effects and Mouth Side Effects, in Children and Young People Aged 0 to 16 Year · NA · not yet recruiting
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- NCT06965101 — To Determine Whether it is Feasible to Treat Patients Requiring Urgent Radiotherapy Diagnosed With Metastatic Cord Compr · NA · recruiting
- NCT05903430 — A Feasibility Study of MRI Guided Stereotactic Ablative Radiotherapy (MIDSECTION) · recruiting
- NCT07202260 — Pragmatic Analysis of Complex Radiotherapy Cases In Cancer of the Lung · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04262427 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Christie NHS Foundation Trust
- Last refreshed: 23 August 2022
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