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NCT07460206: PRELUDE
Pembrolizumab Plus Lenvatinib in REcurrent ccRCC Patients Failing permbroLizUmab aDjuvant trEatment - PRELUDE Study
Phase 2 trial testing Pembrolizumab 200 mg Q3W in ccRCC in 108 participants. Not yet recruiting.
1 August 2031
Quick facts
| Lead sponsor | Gruppo Oncologico Italiano di Ricerca Clinica |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 108 |
| Start date | 1 August 2026 |
| Primary completion | 1 August 2031 |
| Estimated completion | 1 December 2031 |
Drugs / interventions tested
- Pembrolizumab 200 mg Q3W — full drug profile →
- Lenvatinib 20mg QD — full drug profile →
Conditions studied
- ccRCC — all drugs for ccRCC →
Sponsor
Gruppo Oncologico Italiano di Ricerca Clinica
Who can join
18 and older, any sex, with ccRCC. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Primary outcome
Time frame: Five years
PFS: the time from first dose to the first documented PD or death from any cause, whichever occurs first -
Primary outcome
Time frame: Five years
Objective response (OR): a confirmed complete response (CR) or partial response (PR)
Sponsor's own description
This study is being performed as a single-arm open-label study in order to provide information on the potential benefits of the combination of pembrolizumab and lenvatinib in participants with advanced ccRCC who have progressed on Pembrolizumab as their prior therapy in the adjuvant RCC setting.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07460206
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Pembrolizumab 200 mg Q3W
Trials testing the same drug.
- NCT07098988 — Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NS · Phase 2 · recruiting
- NCT03274661 — Pembrolizumab Activity in Patients With Homologous Recombination Competent and Deficient Tumors · Phase 2 · completed
Other recruiting trials for ccRCC
Currently open trials in the same condition.
- NCT07197580 — Phase 3 Study to Assess Safety and Efficacy of 177Lu-TLX250 in Advanced Relapsed or Recurrent ccRCC · Phase 3 · recruiting
- NCT02974738 — A Trial of Belzutifan (PT2977, MK-6482) Tablets In Patients With Advanced Solid Tumors (MK-6482-001) · Phase 1 · active not recruiting
- NCT02293980 — A Phase 1, Dose-Escalation Trial of PT2385 Tablets In Patients With Advanced Clear Cell Renal Cell Carcinoma (MK-3795-00 · Phase 1 · active not recruiting
Other Gruppo Oncologico Italiano di Ricerca Clinica trials
Trials by the same sponsor.
- NCT07381777 — XELOX Plus DoSTARlimab Versus XELOX Alone as Consolidation Treatment After Standard Chemoradiation in pMMR/MSS or MSI-Lo · Phase 2 · not yet recruiting
- NCT07356544 — Observational, Prospective, Multi-centric Study Exploring HER2 Mutations Incidence and Therapeutic Management in aNSCLC · recruiting
- NCT06663098 — Atezolizumab and Rechallenge Chemotherapy in Relapsed Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC). · Phase 2 · recruiting
- NCT06548867 — Retrospective Analysis of Patients With Metastatic Renal Cell Carcinoma Treated With CABOzantinib · recruiting
- NCT06464068 — AGNOSTIC THERAPY IN A PHASE II SINGLE-ARM STUDY IN FIRST-LINE TREATMENT OF DURVALUMAB IN ASSOCIATION WITH CARBOPLATIN OR · Phase 2 · 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 NCT07460206 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Gruppo Oncologico Italiano di Ricerca Clinica
- Last refreshed: 3 March 2026
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/NCT07460206.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing