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

Sponsor
Vall d'Hebron Institute of Oncology
Study ID
NCT07593040
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neoadjuvant Pembrolizumab — DRUG
    400mg q6w of Pembrolizumab will be administered before nephrectomy in cohorts A and B
  • Belzutifan — DRUG
    120mg daily for 12w of Belzutifan will be administered before nephrectomy in Cohorts A and B
  • Lenvatinb — DRUG
    20mg daily for 12 weeks of lenvatinib will be administered before nephrectomy in Cohort A

Study Details

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).

Key Dates

Start date
Jun 30, 2026
Status verified
Nov 2025
Primary completion
Jan 31, 2028
Completion
Jun 30, 2031

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    Neoadjuvant therapy with Pembrolizumab (400mg q6w) + Lenvatinib (20mg daily for 12w) + Belzutifan (120mg daily for 12w). Followed by nephrectomy and pembrolizumab (400mg q6w for 9 months)
  • Experimental: Cohort B
    Neoadjuvant therapy with Pembrolizumab (400mg q6w) + Belzutifan (120mg daily for 12w). Followed by nephrectomy and pembrolizumab (400mg q6w for 9 months)
  • Active Comparator: Cohort C
    Nephrectomy folloewd by pembrolizumab (400mg q6w for 12 months)

Primary Outcome Measure

Response Rate [ Time Frame: At 12 weeks from start of treatment ]

Central Contacts

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