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Pembrolizumab Plus Belzutifan With or Without Lenvatinib in Localized Renal Cell Carcinoma

NCT07593040 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-05-20

No results posted yet for this study

Summary

This study is designed to evaluate the efficacy of belzutifan in combination with pembrolizumab with or without lenvatinib in the neoadjuvant setting, followed by adjuvant pembrolizumab versus adjuvant pembrolizumab alone, as treatment for participants with intermediate-high and high risk clear cell renal cell carcinoma (ccRCC).

Conditions

Interventions

DRUG

Neoadjuvant Pembrolizumab

400mg q6w of Pembrolizumab will be administered before nephrectomy in cohorts A and B

DRUG

Belzutifan

120mg daily for 12w of Belzutifan will be administered before nephrectomy in Cohorts A and B

DRUG

Lenvatinb

20mg daily for 12 weeks of lenvatinib will be administered before nephrectomy in Cohort A

Sponsors & Collaborators

  • Vall d'Hebron Institute of Oncology

    lead OTHER

Principal Investigators

  • Cristina Suárez, Dr · Hospital Vall d'Hebron

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-01-31
Completion
2031-06-30

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07593040 on ClinicalTrials.gov