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Melanoma / Skin
General Information
Study Name:
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)
Age Group:
Adult
Protocol Number:
NCT03820986
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
Contact Information
Contact Name:
Kelly Jeffords, CCRP
Contact Phone:
571-472-0631
Contact Email:
kelly.jeffords@inova.org
For more information go to:
https://clinicaltrials.gov/ct2/show/NCT03820986?term=03820986&rank=1