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Melanoma / Skin
General Information
Study Name:
A Multicenter, Open-label, Phase 2 Trial to Assess the Efficacy and Safety of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Melanoma Previously Exposed to an Anti-PD-1/L1 Agent (LEAP-004)
Age Group:
Adult
Protocol Number:
NCT03776136
Background Information:
The purpose of this study is to:
Test the safety of the study drugs, lenvatinib and pembrolizumab, to see how well the combination of study drugs work together, see how 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 or cytologically 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
Has clinically significant cardiovascular disease within 12 months from first dose of study drug, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability
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/NCT03776136?term=03776136&rank=1