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8110 Gatehouse Road, Falls Church, VA 22042

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

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT04976634

Background Information

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.

Offered At

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

Eligibility Information

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

Ineligibility Information

  • 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 visit: https://www.clinicaltrials.gov/ct2/show/NCT04976634