Study of Front Line Therapy With Nivolumab and Salvage Nivolumab + Ipilimumab in Patients With Advanced Renal Cell Carcinoma

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Michael B. Atkins, MD
Study ID
NCT03117309
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Renal Cell Carcinoma

Eligibility Criteria

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

Interventions

Study Details

Phase II trial of nivolumab in 120 treatment naïve patients with ccRCC.

Key Dates

Start date
Apr 24, 2017
Status verified
Jun 2025
Primary completion
Mar 25, 2022
Completion
Jan 23, 2025

Study Design

Enrollment
164 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: PART A: Nivolumab
    Nivolumab 240mg; Nivolumab 360mg
  • Experimental: PART B: Nivolumab + Ipilimumab
    Nivolumab 3mg/kg and Ipilimumab 1mg/kg; Nivolumab 360mg

Primary Outcome Measure

1-year Progression Free Survival (PFS) Rate for ccRCC Patients [ Time Frame: 1 year ]

Locations (12)

FacilityCityStateZIPSite coordinators
Yale University, Yale Cancer CenterNew HavenConnecticut06520-
Georgetown UniversityWashington D.C.District of Columbia20057-
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322-
Northwestern University Feinberg Schooll Of MedicineChicagoIllinois60611-
University of Illinois Cancer CenterChicagoIllinois60612-
Beth Isreal Deaconess Medical CenterBostonMassachusetts02215-
Hackensack University Medical CenterHackensackNew Jersey07601-
Columbia UniversityNew YorkNew York10032-
Cleveland ClinicClevelandOhio44915-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Univeristy of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Texas Southwestern Medical CenterDallasTexas75390-

Related coverage on Hipa.ai

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By research site
Yale University, Yale Cancer Center· New Haven, CTGeorgetown University· Washington D.C., DCWinship Cancer Institute of Emory University· Atlanta, GANorthwestern University Feinberg Schooll Of Medicine· Chicago, ILUniversity of Illinois Cancer Center· Chicago, ILBeth Isreal Deaconess Medical Center· Boston, MA

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