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Protocol No. UW18079

Principal Investigator Leal, Ticiana

Phase II

Age Group Adult

Scope National

Sponsor Type Industry

Title Phase 2 Precision Oncology Study of Biomarker-Directed, Pembrolizumab- (MK-3475, SCH 900475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (KEYNOTE-495; KeyImPaCT)

Objective This is a study to test a combination of investigational drugs for the treatment of nonsmall cell lung cancer (NSCLC). The purpose of this study is to: test the safety and effectiveness of the study drug, pembrolizumab with specific drugs, to see how well these drugs work in combination and to see how your body handles these drugs in combination. Both pembrolizumab and lenvatinib are approved for sale for the treatment of various types of cancers. MK-4280 is an investigational product and therefore has not been approved for sale. Using a combination of any of the study drugs is investigational

Treatment The possible treatment groups are:
  • Group 1: pembrolizumab (every 3 weeks) + MK-4280 (every 3 weeks)
  • Group 2: pembrolizumab (every 3 weeks) + Lenvatinib (once daily)
    Pembrolizumab is given into a vein (IV) over about 30 minutes once every 3 weeks. MK-4280 is also given IV over about 30 minutes once every 3 weeks. Lenvatinib is a pillthat you will take by mouth at home once a day. Each 3 week period is called a cycle.

  • Description Phase 2 Biomarker-Directed study with Pembrolizumab(MK-3475) based combination therapy for advanced non-small cell lung cancer

    Key Eligibility
  • Have a histologically or cytologically confirmed diagnosis of Stage IV (American Joint Committee on Cancer [AJCC] v. 8) NSCLC and study participants should not have had prior systemic therapy for advanced disease
  • Have confirmation that epidermal growth factor receptor (EGFR-), anaplastic lymphoma kinase (ALK-), c-ros oncogene 1 (ROS1), or B isoform of rapidly accelerated fibrosarcoma (B-Raf) directed therapy is not indicated as primary therapy (documentation of absence of tumor activating EGFR or B-Raf mutations AND absence of ALK or ROS1 gene rearrangements). If participant s tumor is known to have a predominantly squamous histology, molecular testing for EGFR mutation and ALK and ROS1 translocations will not be required, as this is not part of current diagnostic guidelines
  • Must have measureable disease by RECIST 1.1
  • Male and Female subjects and must be at least 18 years of age
  • A male participant must agree to use a contraceptive as described by the protocol
  • A female participant is eligible to participate if she is not pregnant and not breastfeeding, and must agree to contraceptive as described by the protocol
  • Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Newly obtained biopsies are preferred to archival tissue. Repeat samples may be required if adequate tissue is not provided
  • Participants must have adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mm Hg at Screening and no change in antihypertensive medications within 1 week before Cycle 1/Day 1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Have adequate organ function as defined by the protocol
  • Has significant cardiovascular impairment within 12 months of the first dose of study drug
  • Prolongation of QTc interval to greater than 480 ms
  • Has symptomatic ascites or pleural effusion
  • Has had an allogenic tissue/solid organ transplant
  • Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib
  • Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug
  • Has received prior systemic chemotherapy treatment for metastatic/recurrent NSCLC
  • Has received prior therapy with an anti PD-1, anti PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T cell receptor
  • Has received previous treatment with another agent targeting the LAG3 receptor
  • Has received previous treatment with another agent targeting VEGF or the VEGF receptor
  • Has received a live vaccine within 30 days prior to the first dose of study treatment
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has known active CNS metastases and/or carcinomatous meningitis
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection
  • Has a known history of hepatitis B or known active hepatitis C virus
  • Has a known history of active tuberculosis

  • Applicable Disease Sites Lung

    Status Open

    Participating Institutions UW Hospital and Clinics