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)
Merck Sharp & Dohme LLC
Summary
Researchers are looking for more ways to treat advanced renal cell carcinoma (RCC) that is recurrent. Researchers want to learn if recurrent advanced renal cell carcinoma (RCC) responds (gets smaller or goes away) after treatment with belzutifan (MK-6482) and zanzalintinib compared to cabozantinib. The goal of this study is to learn if: People who take belzutifan and zanzalintinib live longer overall and without the cancer getting worse than people who take cabozantinib.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has a histologically confirmed diagnosis of unresectable, advanced renal cell cancer (RCC) with clear cell component (with or without sarcomatoid features) i.e., Stage IV renal cell cancer per American Joint Committee on Cancer (AJCC) (8th Edition) * Has measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) * Has disease recurrence during adjuvant anti-programmed cell death 1/programmed cell death ligand 1 (PD-1/L1) therapy or recurrence ≤24 months following the last…
Interventions
- DrugBelzutifan
Administered orally QD
- DrugZanzalintinib
Administered orally QD
- DrugCabozantinib
Administered orally QD
Locations (127)
- Alaska Oncology and Hematology ( Site 0133)Anchorage, Alaska
- Providence Medical Foundation ( Site 0141)Fullerton, California
- USC Norris Comprehensive Cancer Center ( Site 0126)Los Angeles, California
- Cedars-Sinai Medical Center ( Site 0112)Los Angeles, California
- New England Cancer Specialists ( Site 0132)Westbrook, Maine
- Greater Baltimore Medical Center ( Site 0145)Baltimore, Maryland