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8110 Gatehouse Road, Falls Church, VA 22042

A Phase 3 Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) and Lenvatinib (E7080/MK-7902) Versus Pembrolizumab Alone as First-line Intervention in Participants with Advanced Melanoma (LEAP-003)


General Information

Age Group




Protocol Number


Background Information

The purpose of this study is to:

  • See how well the combination of study drugs (lenvatinib and pembrolizumab) work together
  • Test the safety and how well your body handles the combination of the study drugs
  • Find out how lenvatinib is absorbed and broken down in your body when given with pembrolizumab
  • Test the combination of the study drugs and see if they help patients live longer

Offered At

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

Eligibility Information

  • Participants must be 18 years of age or older
  • Histologically confirmed melanoma
  • Have unresectable Stage III or Stage IV melanoma, as per American Joint Committee on Cancer 8th edition guidelines, not amenable to local therapy
  • Have the presence of at least 1 measurable lesion by CT or MRI
  • Additional eligibility in protocol

Ineligibility Information

  • A diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment
  • A known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or stage 1, non-ulcerated primary melanoma <1 mm in depth with no nodal involvement) treated with curative intent, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy
  • Ocular melanoma
  • Additional ineligibility in protocol

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