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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Number of participants with treatment-related adverse events as assesses by CTCAE version 4.03.
Time frame: 58 weeks
Determine the recommended phase 2 dose (RP2D) based on Dose limiting toxicities
Time frame: 6 weeks
To evaluate the investigator assessed ORR using standard response evaluation criteria in solid tumors (RECIST) version 1.1 for metastatic renal cell carcinoma.
Time frame: 2 years
To evaluate the investigator assessed ORR using standard response evaluation criteria in solid tumors (RECIST) version 1.1 for metastatic urothelial cancer.
Time frame: 2 years
To evaluate median progression free survival (PFS) using Kaplan-Meier curves for metastatic renal cell carcinoma.
Time frame: 2 years
To evaluate median progression free survival (PFS) using Kaplan-Meier curves for metastatic urothelial cancer.
Time frame: 2 years
To evaluate median overall survival (OS) using Kaplan-Meier curves for metastatic renal cell carcinoma.
Time frame: 2 years
To evaluate median overall survival (OS) using Kaplan-Meier curves for metastatic urothelial cancer.
Time frame: 2 years
To investigate the relationship between PD-L1 expression on tumor cells and on immune cells using IHC and SMI methods.
Time frame: Baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
To investigate the relationship between PD-L1 expression on tumor cells and on immune cells using IHC and SMI methods.
Time frame: week 2
To investigate the relationship between PD-L1 expression on tumor cells and on immune cells using IHC and SMI methods.
Time frame: week 7