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

NCT03451331 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2024-05-16

Study results available
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Summary

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.

Conditions

  • Metastatic Urothelial Cancer

Interventions

DRUG

Nivolumab

Nivolumab 360mg (and/or) Maintenance Single Agent Nivolumab 480mg (starting \~ 2-4 weeks after completing combination chemotherapy plus nivolumab)

DRUG

Gemcitabine

1000 mg/m\^2

DRUG

Carboplatin

AUC 4.5 (based on the Calvert formula)

DRUG

Oxaliplatin

130 mg/m\^2

Sponsors & Collaborators

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Hoosier Cancer Research Network

    collaborator OTHER

  • Matthew Galsky

    lead OTHER

Principal Investigators

  • Matthew Galsky, M.D. · Icahn School of Medicine at Mount Sinai; Tisch Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-10
Primary Completion
2023-06-07
Completion
2023-07-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03451331 on ClinicalTrials.gov