Study of Nivolumab and Axitinib in Patients With Advanced Renal Cell Carcinoma

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Fox Chase Cancer Center
Study ID
NCT03172754
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    PD-1 inhibitor
  • Axitinib — DRUG
    Tyrosine kinase inhibitor

Study Details

This is a Phase I/II, open-label, multi-center study of axitinib in combination with nivolumab in patients with previously treated and untreated advanced RCC. This clinical study will be composed of a dose finding phase (Phase I) and two parallel dose expansion phases (Phase II). The dose finding phase will assess the safety of the combination and establish a recommended phase II dose (RP2D, the highest tested dose that is declared safe and tolerable by the Investigators and the Sponsor Investigator) in patients with advanced RCC who have received prior systemic therapy for metastatic disease. Phase II will evaluate the efficacy of the combination at the RP2D in two parallel expansion cohorts in both previously treated and treatment naïve patients.

Key Dates

Start date
Jun 12, 2017
Status verified
May 2026
Primary completion
Nov 6, 2026
Completion
Apr 6, 2027

Study Design

Enrollment
98 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I patients
    Phase I patients must have received at least 1 prior tyrosine kinase inhibitor for RCC.
  • Experimental: Phase II patients: cohort 1
    Phase II cohort 1 patients must have received at least 1 prior tyrosine kinase inhibitor for RCC.
  • Experimental: Phase II patients: cohort 2
    Phase II cohort 2 patients must not have received prior systemic therapy for advanced RCC.

Primary Outcome Measure

Incidence of treatment-related adverse events [ Time Frame: Up to 15 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
Johns HopkinsBaltimoreMaryland21231-
US Oncology and HematologyAlbanyNew York12206-
CornellNew YorkNew York10021-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-

Find similar trials in Baltimore, MD

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
Johns Hopkins· Baltimore, MDUS Oncology and Hematology· Albany, NYCornell· New York, NYFox Chase Cancer Center· Philadelphia, PA

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