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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)

Status
Active
Cancer Type
Kidney Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04586231
Protocol IDs
6482-011 (primary)
MK-6482-011
NCI-2020-11420
2020-002075-35
Study Sponsor
Merck Sharp & Dohme LLC

Summary

This study will compare the efficacy and safety of belzutifan + lenvatinib versus
cabozantinib in participants with advanced renal cell carcinoma (RCC) with clear cell
component after prior therapy.

The primary hypothesis is that belzutifan + lenvatinib is superior to cabozantinib in terms
of progression-free survival or overall survival.

Eligibility

  1. Unresectable, locally advanced or metastatic clear cell renal cell carcinoma (RCC).
  2. Disease progression on or after an anti-programmed cell death-1/ligand 1 (PD-1/L1) therapy as either first or second-line treatment for locally advanced/metastatic RCC or as adjuvant treatment with progression on or within 6 months of last dose.
  3. Measurable disease per RECIST 1.1 criteria as assessed by local study investigator.
  4. Karnofsky performance status (KPS) score of at least 70% assessed within 10 days before randomization.
  5. Received no more than 2 prior systemic regimens.
  6. Received only 1 prior antiPD-1/L1 therapy for adjuvant or locally advanced/metastatic RCC.
  7. A male participant is eligible to participate if he is abstinent from heterosexual intercourse or agrees to use contraception during the intervention period and for at least 7 days after the last dose of belzutifan or lenvatinib in the belzutifan+lenvatinib arm, whichever occurs last, and 23 days after the last dose of cabozantinib.
  8. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 30 days after the last dose of study intervention in the belzutifan+ lenvatinib arm, or 120 days after the last dose of study intervention in the cabozantinib arm.
  9. Adequately controlled blood pressure.
  10. Adequate organ function.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.