Clinical Trial 17937

Cancer Type: Cutaneous
Interventions:BMS-936558 (Nivolumab); Nivolumab; Not Applicable; Urelumab

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Nikhil Khushalani

Overview

Study Title

A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety and Tolerability of Urelumab Administered in Combination with Nivolumab in Advanced /Metastatic Solid Tumors and B Cell Non-Hodgkins Lymphoma

Summary

The main purpose of this study is to test the safety and tolerability of the combination of two investigational drugs called urelumab (also known as BMS-663513) and nivolumab (also known as BMS-936558).

Objective

Research Hypothesis: It is anticipated that the combination of an anti-CD137 (urelumab) and an anti PD-1 antibody (nivolumab) will demonstrate adequate safety and tolerability at pharmacologically relevant doses, so as to permit further clinical testing. There is no formal primary research hypothesis for this study to be statistically tested. Objectives: Primary Objective: To assess the safety and tolerability of urelumab given in combination with nivolumab and to identify dose limiting toxicities (DLTs) and the maximally tolerated dose (MTD) of the combination, in subjects with advanced (metastatic and/or unresectable) solid tumors and B cell lymphomas. Secondary Objectives: - To assess the preliminary anti-tumor activity of the combination of urelumab and nivolumab in subjects with advanced solid tumors and B cell lymphomas. - To characterize the pharmacokinetics (PK) of urelumab and nivolumab when co-administered. - To monitor immunogenicity of urelumab and nivolumab administered as combination therapy. Exploratory Objectives: - To assess the pharmacodynamic effects of urelumab as a function of exposure when given in combination with nivolumab in peripheral blood and tumor tissue. - To explore potential associations between biomarker measures and anti-tumor activity. - To assess the overall survival (OS) following the start of therapy with the combination of urelumab and nivolumab.

Inclusion Criteria

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  • Age 18 years or older For Dose Escalation:
  • Potential participants with any previously treated advanced (metastatic or refractory) solid tumor type and B-cell non-Hodgkin lymphoma. For Cohort Expansion:
  • Must have a previously treated advanced solid tumor or B cell non-Hodgkin's lymphoma to be eligible.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men.

  • Exclusion Criteria

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  • Known central nervous system metastases or central nervous system as the only source of disease.
  • Other concomitant malignancies (with some exceptions per protocol).
  • Active, known or suspected autoimmune disease.
  • Uncontrolled or significant cardiovascular disease.
  • History of hepatitis (B or C).
  • History of active or latent tuberculosis.