RENAL CELL: METASTATIC: 2nd/3rd Line: MK-6482-013

Phase 2 Study of MK-6482 in Participants With Advanced Renal Cell Carcinoma

Title
Merck MK6482-013 (Renal cell belzutifan)
Study Title

Phase 2 Study of MK-6482 in Participants With Advanced Renal Cell Carcinoma

Site Link
Malignancy
Renal cell carcinoma, Kidney cancer, clear cell, RCC
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
2nd, 3rd, or 4th
Investigational Agent
Belzutifan
Drug Class
HIF-2a inhibitor
PI
Dan Vaena, MD
Sponsor
Merck Sharp & Dohme Corp
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Histologically confirmed diagnosis of locally advanced/metastatic RCC with clear cell component
  • Has had disease progression on or after having received 1st line systemic treatment for RCC with CTLA4+PD1 or VEGF-TKI+PD1
  • No more than 3 prior lines of therapy
  • KPS >/= 70
  • No requirement for supplemental oxygen at baseline
  • No prior cancer within 3 years
  • No known CNS mets
  • No significant cardiac disease
  • No receipt of GCSF or EPO within 28 days prior to first dose
  • No known HBV/HCV/HIV
Objective
  • Primary
    • ORR
  • Secondary
    • PFS
    • DOR
    • CBR
    • OS
    • Safety
Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
Clear cell component
Dosing Frequency
Control Agents
Study Protocol
Randomized
Yes
X