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Protocol No. UW18133

Principal Investigator Uboha, Nataliya

Phase II

Age Group Adult

Scope National

Sponsor Type Industry

Title 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)

Objective
  • Evaluate objective response rate (ORR) by standard criteria
  • Assess safety and tolerability of the study regimen
  • Evaluate disease control rate (DCR) adn progression-free survival (PFS)
  • Evaluate overall survival (OS)
  • Characterize pharmacokinetics of lenvatinib when co-administered with pembrolizumab

  • Treatment
  • Pembrolizumab 200 mg IV every 3 weeks
  • Lenvatinib 20 mg oral daily

  • Description Phase 2 study using Lenvatinib plus Pembrolizumab in Previously Treated Subjects with Selected Solid Tumors

    Key Eligibility
    Cohort-specific prior line requirements:
  • Triple-negative breast: 1 or 2 prior lines, and must have received taxanes or anthracyclines at some point. Includes surgery and/or adjvuant therapy if recurred within 6 months
  • Ovarian: Exactly 3 prior lines. Includes neo/adjuvant chemotherapy
  • Gastric: Exactly 2 prior lines. Includes neo/adjuvant therapy if recurred within 12 months
  • Colorectal: Exactly 2 prior lines. Must have received both FOLFOX and FOLFIRI or equivalent. FOLFIRINOX counts as 1 line. Includes adjuvant therapy if recurred within 6 months
  • Glioblastoma: Exactly 1 prior line of systemic therapy.
  • Biliary tract: Exactly 1 prior line. Includes adjuvant therapy if recurred within 6 months.
    INCLUSION
  • Histologically confirmed advanced solid tumor for which prior standard systemic therapy has failed and is in one of the following disease categories: Triple-negative breast cancer, ovarian, gastric, colorectal (non-MSI-H/pMMR), glioblastoma, or biliary tract cancers (includes cholangiocarcinoma and gall bladder cancer; excludes Ampulla of Vater)
  • Disease progression on or since previous treatment
  • Measurable disease per RECIST 1.1 or RANO criteria
  • Availability of archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
  • Life expectancy of at least 12 weeks
  • ECOG performance status of 0 to 1
  • Adequate organ function as defined by the protocol
  • Adequately controlled blood pressure as defined by the protocol
    EXCLUSION
  • Radiographic evidence of major blood vessel invasion/infiltration
  • Prior treatment with lenvatinib or immunotherapy
  • Known active central nervous system metastases and/or carcinomatous meningitis
  • Hemoptysis or tumor bleeding within 2 weeks prior to day 1
  • History of arterial thromboembolism within 12 months of day 1
  • Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10 mg daily of prednisone equivalent)
  • History of non-infectious pneumonitis requiring systemic steroids
  • Known history of human immunodeficiency virus (HIV) infection, known history of hepatitis B, known active hepatitis C, or known history of active tuberculosis
  • Previous allogenic tissue/solid organ transplant

  • Applicable Disease Sites Brain/Central Nervous System; Breast; Colon and Rectum; Gastrointestinal cancers, other; Ovary; Stomach

    Status Open

    Participating Institutions UW Hospital and Clinics