Clinical Trials Search
Clinical Trial 19491
Cancer Type: Multiple
Interventions:BMS-936558 (Nivolumab); IRX-2; Nivolumab; cyclophosphamide; cytoxan (cyclophosphamide)
Study Type: Treatment
Phase of Study: Phase I
Investigators:
- Solmaz Sahebjam
Study Title
The IRX-2 Regimen Combined with Nivolumab in Recurrent/Metastatic Solid Tumors: A Phase 1b Study to Evaluate the Safety, Determine Recommended Phase 2 Dose (RP2D), and Investigate the Biologic and Clinical Activity
Summary
Objective
Primary Objective: - To determine the safety profile of the combination of IRX-2 regimen with nivolumab. Secondary Objective(s): - To evaluate the objective clinical response rate of IRX-2 regimen combined with nivolumab using RECIST 1.1 and immune modified RECIST criteria . - To evaluate the progression-free survival of combination therapy at 6 and 12 months. Exploratory Objective(s): - To evaluate the biological effects of combination therapy determined by changes in the density of lymphocyte infiltration in the tumor and tumor microenvironment. - To evaluate the biological effects of combination therapy determined by changes in the T-cell receptor repertoire diversity. - To evaluate the biological effects of combination therapy determined by evaluation of peripheral blood mononuclear cells.