An Open-label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Multiple Solid Tumors (MK6482-016)

This trial is testing pembrolizumab (pembro) + lenvatinib + belzutifan (called the “trial drugs” in this form) in people with certain types of solid tumors.  The trial hopes to produce additional information about safety, tolerability, effectiveness, and long term survival.

Pembro (also called KEYTRUDA™) and lenvatinib (also called LENVIMA®) have been approved by the U.S. Food and Drug Administration (FDA) to treat many cancer types.

Belzutifan (MK-6482) is an experimental drug that has not been approved by the FDA for sale.

Taking the trial drugs together is experimental.

Inova Schar Cancer Institute
A division of Inova Fairfax Hospital
8081 Innovation Park Drive
Fairfax, VA 22031

• Adults 18 years of age or older
• Has histopathologically or cytopathologically documented, advanced (unresectable and/or metastatic) solid tumors of the esophagus and liver
• Disease progression after treatment
• Additional eligibility in protocol.

• Inability to swallow pills
• CNS metastases
• Cardiovascular disease
• Pregnancy/nursing
• Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to any costimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX-40, or CD137) either alone or in combination with another agent in any treatment setting (including adjuvant); prior treatment with any HIF-2α inhibitor (including belzutifan) or lenvatinib
• Additional ineligibility in protocol.

For additional information, please see: https://www.clinicaltrials.gov/ct2/show/NCT04976634