A Multicenter Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects with Selected Solid Tumors (LEAP-005)
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Multiple Solid Tumors
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Age: Between 18 - 100 Years
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Gender: Male or Female
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Other Inclusion Criteria:
1) Have a histologically or cytologically-documented, advanced (metastatic and/or unresectable) solid tumor that is incurable and for which prior standard systemic therapy has failed in one of the following groups: Ovarian Cancer Gastric Cancer Colorectal Cancer (non-MSI-H/pMMR tumor) Glioblastoma (GBM) Biliary Tract Cancer (BTC) (intrahepatic, extrahepatic cholangiocarcinoma and gall bladder cancer; excludes Ampulla of Vater) 2) Participants must have progressed on or since the last treatment. 3) Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
You may not be eligible for this study if the following are true:
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1) Has presence of gastrointestinal condition including malabsorption that might affect the absorption of lenvatinib. 2) Radiographic evidence of major blood vessel invasion/infiltration. The degree of tumor invasion/infiltration of major blood vessels should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis following lenvatinib therapy. 3) Clinical significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug.
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