MK-6482-11 An Open-label, Randomized, Phase 3 Study of MK-6482 in Combination with Lenvatinib (MK-7902) vs Cabozantinib for Second-line or Third-line Treatment in Participants with Advanced Renal Cell Carcinoma Who Have Progressed After Prior Anti-PD-1/L1 Therapy

About this Study

The purpose of this study is to test KM-6482 plus Lenvatinib in people with a type of kidney cancer called advanced clear cell Renal Cell Carcinoma (ccRCC).

Sponsor Protocol ID:011-00
IRB Number:2020V0409
Actively Enrolling
Interventional
Phase 3
March 31, 2022
Eligibility Criteria
18 years old
Both Male and Female
Yes
No
Yes

Inclusion Criteria
  • Must have histologically confirmed diagnosis of unresectable, locally advanced/metastatic renal cell carcinoma (RCC) with clear cell component
  • Has experienced disease progression on or after first or second line systemic treatment with an anti-PD-1/L1 therapy for locally advanced or metastatic RCC.
  • Must not have received no more than 2 prior systemic regimens for locally advance or metastatic RCC
  • Must be 18 years of age or older
  • Must have controlled blood pressure with or without blood pressure medications (less than 150/90 mm Hg)

Exclusion Criteria
  • Pregnant or have positive urine pregnancy test within 24 hours before first dose of study drug
  • Must not have hypoxia (pulse oximeter reading less than 92%)
  • Require intermittent supplemental oxygen or chronic supplemental oxygen
  • Have another cancer that is getting worse or has required active treatment within the past 3 years
  • Has known CNS metastases and/or carcinomatous meningitis
  • Has clinically significant cardiovascular disease within 12 months, such as congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident or abnormal heart beats
  • Has received prior treatment with MK-6482, lenvatinib, or cabozantinib
  • Received radiation within two weeks before randomization
  • Received any type of systemic anticancer antibody (including investigational antibody) less than or equal to 28 days before randomization
  • Known HIV

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Cancer
Participating Locations
Cancer Center and Research Institute - UMMC
Contact Information
Contact Name: Eulisa Goins-Freeman
Phone Number: 601-815-3936
Email: efreeman2@umc.edu
Principal Investigator:Henegan, John C, M.D.
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