Gemcitabine + Carboplatin + Nivolumab Versus Gemcitabine + Oxaliplatin + Nivolumab in Cisplatin-ineligible Patients With Metastatic Urothelial Cancer

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Matthew Galsky
Study ID
NCT03451331
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Urothelial Cancer

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab 360mg (and/or) Maintenance Single Agent Nivolumab 480mg (starting \~ 2-4 weeks after completing combination chemotherapy plus nivolumab)
  • Gemcitabine — DRUG
    1000 mg/m\^2
  • Carboplatin — DRUG
    AUC 4.5 (based on the Calvert formula)
  • Oxaliplatin — DRUG
    130 mg/m\^2

Study Details

This is a randomized phase 2 trial of gemcitabine + carboplatin + nivolumab or gemcitabine + oxaliplatin + nivolumab for the treatment of cisplatin-ineligible patients with metastatic urothelial cancer. Randomization will be stratified on the lymph node only (and/or unresectable primary) metastatic status.

Key Dates

Start date
May 10, 2018
Status verified
Apr 2024
Primary completion
Jun 7, 2023
Completion
Jul 28, 2023

Study Design

Enrollment
49 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Gemcitabine plus carboplatin plus nivolumab
  • Experimental: Arm B
    Gemcitabine plus oxaliplatin plus nivolumab

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to a maximum of 50 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21287-
John Theuer Cancer CenterHackensackNew Jersey07601-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Icahn School of Medicine: Tisch Cancer Institute at Mount Sinai Medical CenterNew YorkNew York10029-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-
Huntsman Cancer Institute University of UtahSalt Lake CityUtah84112-

Find similar trials in Baltimore, MD

By research site
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center· Baltimore, MDJohn Theuer Cancer Center· Hackensack, NJRutgers Cancer Institute of New Jersey· New Brunswick, NJIcahn School of Medicine: Tisch Cancer Institute at Mount Sinai Medical Center· New York, NYVanderbilt-Ingram Cancer Center· Nashville, TNHuntsman Cancer Institute University of Utah· Salt Lake City, UT

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