Clinical Trial 19114

Cancer Type: Multiple
Interventions:BMS-936558 (Nivolumab); Daratumumab; Nivolumab

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

  • Heather Han

Overview

Study Title

Phase 1/2 Study to Evaluate the Safety and Preliminary Efficacy of Nivolumab Combined with Daratumumab in Participants with Advanced or Metastatic Solid Tumors

Summary

The purpose of this study is to determine whether a combination of nivolumab and daratumumab is safe and effective when treating advanced tumors or tumors that have spread.

Objective

Primary: - To establish the tolerability of the combination of nivolumab and daratumumab in participants with advanced or metastatic solid tumors. Secondary: - To evaluate the objective response rate (ORR) of nivolumab combined with daratumumab in participants with advanced or metastatic tumors in each cohort. - To assess progression free survival (PFS) of nivolumab combined with daratumumab in participants with advanced or metastatic tumors in each cohort. - To characterize the pharmacokinetics of nivolumab and daratumumab in participants with advanced or metastatic tumors. - To characterize the immunogenicity of nivolumab and daratumumab in participants with advanced or metastatic tumors. Tertiary/Exploratory: - To evaluate the pharmacodynamic activity of nivolumab and daratumumab on selected markers of immune modulation in peripheral blood and tumor samples - To investigate the potential association between selected biomarker measures and clinical efficacy measures. - To assess overall survival (OS) of nivolumab combined with daratumumab in participants with advanced or metastatic tumors in each cohort.

Inclusion Criteria

  • Patients with metastatic or advanced solid tumors
  • Women with histologically or cytologically confirmed triple negative breast carcinoma
  • Histologically or cytologically confirmed pancreatic adenocarcinoma
  • Histologically or cytologically confirmed Non Small Cell Lung Cancer (NSCLC)

  • Exclusion Criteria

  • Active brain metastases or leptomeningeal metastases.
  • Any serious or uncontrolled medical disorder
  • Prior malignancy active within the previous 3 years
  • Other protocol defined inclusion/exclusion criteria could apply