Pegzilarginase and Pembrolizumab for Extensive Disease Small Cell Lung Cancer

You may not qualify if:

• Has received more than 2 platinum-based regimens against SCLC
• Has received pembrolizumab, or prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody as part of any previous therapy, including trials
• Has participated in Merck MK-3475 (pembrolizumab) clinical trials
• Has received pegzilarginase as part of any previous therapy
• Is currently participating in a study of an investigational agent or received the last dose of an investigational agent within 4 weeks prior to the first dose of treatment in this study (a shorter interval for kinase inhibitors or other short half-life drugs could be considered after approval from the Sponsor). Is currently participating in a study of an investigational device within 4 weeks of the first dose of treatment
• Has a diagnosis of an immunodeficiency, is receiving systemic steroid therapy (except for physiological dose levels), or immunosuppressive therapies
• Has had a prior monoclonal antibody (mAb) within 4 weeks prior to first dose or who has not recovered (i.e., ≤ Grade 1) from adverse reactions due to agents administered more than 4 weeks earlier
• Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose or who has not recovered (i.e., ≤ Grade 1 or at baseline) from treatment-emergent adverse reactions due to a previously administered agent
• If the patient has undergone major surgery, must have recovered adequately from the toxicity and/or complications prior to starting therapy
• Has received transfusion of blood products or administration of colony stimulating factors within 14 days prior to first study dose
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer) that has undergone potentially curative therapy
• Has known central nervous system (CNS) metastases. However, patients with previously treated brain metastases may participate provided neurologic symptoms have stabilized, there is no evidence of new brain metastases or hemorrhage and they are not using steroids for brain metastases or for complications derived from their treatment for at least 7 days prior to the first dose of study treatment
• Has known carcinomatous meningitis
• Has an active autoimmune disease requiring systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs) or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo or resolved childhood asthma/atopy are an exception to this rule. Patients that require intermittent use of bronchodilators or local steroid injections will not be excluded from the study. Patients with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment
• Has evidence of interstitial lung disease, history of non-infectious pneumonitis that required steroids, or current pneumonitis
• +15 more criteria