Substudy 03C: A Study of Combination Therapies in Participants With Renal Cell Carcinoma With Recurrent Disease During or After Anti-PD-(L)1 Therapy (MK-3475-03C/KEYMAKER-U03)

Substudy 03C is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03). The goal of substudy 03C is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with clear cell renal cell carcinoma (ccRCC) who have recurrent disease during or after anti-programmed cell death 1/programmed cell death ligand 1 (PD-\[L\]1) adjuvant therapy. This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used

Trial Details

NCT ID
NCT07049926
Phase
PHASE1 / PHASE2
Sponsor
Merck Sharp & Dohme LLC
Status
RECRUITING
Cancer Type
Kidney Cancer
Interventions
  • Belzutifan
  • Zanzalintinib
Locations (sample)
  • San Francisco, California, United States|37.77493,-122.41942
  • Mineola, New York, United States|40.74927,-73.64068
  • New York, New York, United States|40.71427,-74.00597
  • New York, New York, United States|40.71427,-74.00597
  • Durham, North Carolina, United States|35.99403,-78.89862

Key Eligibility Criteria

  • Has a histologically confirmed diagnosis of unresectable locally advanced/metastatic renal cell carcinoma (RCC) with clear cell component
  • Has received no other prior systemic therapy for treatment of advanced/metastatic clear cell renal cell carcinoma (ccRCC) except for adjuvant progr…
  • Has disease recurrence during adjuvant anti- PD-(L)1 therapy or ≤24 months following the last dose of adjuvant anti-PD-(L)1 therapy
  • Is able to swallow oral medication

For full eligibility, visit ClinicalTrials.gov.

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