NCT02614456

Combination of Interferon-gamma and Nivolumab for Advanced Solid Tumors

Combination Immunotherapy With Interferon-gamma and Nivolumab for Patients With Advanced Solid Tumors: A Phase 1 Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I study of combination immunotherapy with IFN-γ and the PD-1 inhibitor nivolumab in patients with advanced solid tumors who have progressed on at least one prior systemic therapy, which may include prior immunotherapy.

Detailed description

This is a phase I study of combination immunotherapy with IFN-γ and the PD-1 inhibitor nivolumab in patients with advanced solid tumors who have progressed on at least one prior systemic therapy, which may include prior immunotherapy. Patients will be treated with a one week induction phase (IP) of IFN-γ, followed by a combination phase (CP) with IFN-γ and nivolumab for three cycles, followed by a single agent phase of only nivolumab for up to one year. The study will primarily assess the safety and tolerability of the combination. Tumor assessments will occur after three cycles of combination therapy, then every three cycles thereafter. Secondary objectives including ORR, PFS, and OS will also be assessed, as will various correlative analyses. Initial accrual will occur using a modified 6+6 design, and if endpoints for safety (using DLT criteria) are met, expansion cohorts in RCC and UC will be opened for up to 15 patients.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	interferon-gamma and nivolumab

Timeline

• Start date: 2015-12-11
• Primary completion: 2019-06-12
• Completion: 2019-06-12
• First posted: 2015-11-25
• Last updated: 2019-11-29

Locations

1 site across 1 country: United States