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A Phase l/ll Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of Anti-CD27 Antibody (Varlilumab) Administered in Combination With Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors

Primary Objective *Phase I: To assess the safety and tolerability of varlilumab (0.1 to 10 mg/kg i.v. every 2 weeks) in combination with nivolumab (3 mg/kg i.v. every 2 weeks), and to identify dose limiting toxicities (DLT's) and the recommended Phase II dose of Varlilumab for use in combination with Nivolumab, in patients with specific advanced (metastatic and/or unresectable) solid tumors (NSCLC, MEL, CRC, ovarian cancer and SCCHN) *Phase II: To assess the preliminary antitumor activity, of the combination of varlilumab (given at multiple doses and schedules) and nivolumab (240 i.v. every 2 weeks), in patients with metastatic and/or unresectable CRC, ovarian cancer, RCC and SCCHN, as measured by objective response rate (ORR) and by OS12 in patients with GBM. Secondary Objectives: *To assess the pharmacokinetics (PK) of varlilumab wen given in combination with nivolumab *Determine the immunogenicty of varlilumab and nivolumab when given in combination. *To further assess the antitumor activity of combination treatment, as assessed by duration of response (DOR), time to response (TTR), progression-free survival (PFS), PFS at 6 months (PFS6), overall survival (OS), and landmark OS at 2 years (OS24) and three years (OS36) following the start of therapy with the combination of varlilumab and nivolumab. *Determine ORR for patients with GBM using Immunotherapy Radiologist Assessment in Neuro-Oncology (iRano) Criteria (Okada, Weller et al. 2015) and Radiologic Assessment in Neuro-Oncology (RANO) Criteria (Wen, Macdonald et al. 2010) Exploratory Objectives: *To assess the pharmocodynamic effect in tumor tissue on tumor infiltrating lymphocyte (TIL) subsets from MEL, CRC, ovarian cancer, SCCHN, GBM and RCC patients treated with varlilumab and nivolumab *To assess the pharmacodynamic effects of varlilumab versus dose and/or exposure given in combination with nivolumab on biomarkers in peripheral blood, including T cell compartments, and serum proteins (cytokines and other immune modulators) *To explore potential associations between biomarker measures and antitumor activity *To further characterize biomarker measures of immune functioning at multiple dose levels of varlilumab when given in combination with nivolumab *Examine any correlation of serum concentration of varlilumab and nivolumab with toxicity and outcome



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