CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 49 enrolled
Drug / intervention
Nivolumab +3 moredrug
Likely dose
Nivolumab 360mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03451331
NCT03451331Phase 2Completed
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Randomized Phase 2 Trial of Gemcitabine + Carboplatin + Nivolumab Versus Gemcitabine + Oxaliplatin + Nivolumab in Cisplatin-ineligible Patients With Metastatic Urothelial Cancer

Matthew Galsky·interventional·Posted Mar 1, 2018·Updated May 16, 2024

In Brief

A Phase 2 clinical trial evaluating Nivolumab, Gemcitabine, and 2 other interventions for Metastatic Urothelial Cancer. Completed, enrolled 49 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Urothelial Cancer
CountriesUnited States
CollaboratorsBristol-Myers Squibb, Hoosier Cancer Research Network

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMar 1, 2018
Enrollment StartMay 10, 2018
Primary CompletionJun 7, 2023
Study CompletionJul 28, 2023
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 8.3 years ago

Interventions

Nivolumabdrug

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

Gemcitabinedrug

1000 mg/m\^2

Carboplatindrug

AUC 4.5 (based on the Calvert formula)

Oxaliplatindrug

130 mg/m\^2