Combination of Interferon-gamma and Nivolumab for Advanced Solid Tumors

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Fox Chase Cancer Center
Study ID
NCT02614456
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Nov 25, 2015
Start date
Dec 11, 2015
Status verified
Nov 2019
Primary completion
Jun 12, 2019
Completion
Jun 12, 2019

Study Design

Enrollment
26 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Interferon-gamma and nivolumab
    Interferon-gamma (IFN-γ): starting dose 50 mcg/m2 subcutaneously Nivolumab: 3 mg/kg intravenously Induction phase: IFN-γ every other day alone for 1 week Combination phase: IFN-γ every other day \& Nivolumab every 2 weeks for 3 months Single agent phase: Nivolumab every 3 weeks up to 1 year

Primary Outcome Measure

Number of participants with treatment-related adverse events as assesses by CTCAE version 4.03. [ Time Frame: 58 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-

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By research site
Fox Chase Cancer Center· Philadelphia, PA

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