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Clinical Trials in the EU / 2024-517136-21-00
Authorised, recruiting Phase III

A Phase 3, Randomized, Open-label Study of Belzutifan + Zanzalintinib Versus Cabozantinib in Participants with Advanced RCC who Experienced Disease Recurrence During or After Prior Adjuvant Anti-PD-1/L1 Therapy (LITESPARK-033)

2024-517136-21-00 · tracked via the Priya Life Science EU tracker
Sponsor
Merck Sharp & Dohme LLC
Sponsor type
Pharmaceutical company
Therapeutic area
Neoplasms
Decision date
10/11/2025
Enrollment target
398
Sites
Greece, Germany, France, Italy, Croatia, Denmark, Czechia, Austria, Belgium, Ireland, Spain, Poland

Condition studied

Renal Cell Carcinoma

Investigational medicinal product(s)

Cabozantinib Ipsen 20 mg film-coated tabletsXL092Cabozantinib Ipsen 60 mg film-coated tabletsBELZUTIFAN

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

Progression free survival, Overall survival

Endpoint detail

Objective Response Rate, Duration of Response, Number of participants with ≥1 AE(s), Number of participants who discontinue study therapy due to AE(s), Change from baseline in European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) global health/health-related quality of life (HRQoL) score, Change from baseline in EORTC QLC-C30 physical functioning score, Change from baseline in EORTC QLQ-C30 role functioning score, Change from baseline in Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) score, Time from baseline to first deterioration in EORTC-QLC-C30 global health/HRQoL score, Time from baseline to first deterioration in EORTC-QLC-C30 physical functioning score, Time from baseline to first deterioration in EORTC-QLC-C30 role functioning score, Time from baseline to first deterioration in FKSI-DRS score

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2024-517136-21-00 on CTIS ↗ ← All trials in the EU