Gemcitabine, Cisplatin, Plus Nivolumab in Patients With Muscle-invasive Bladder Cancer With Selective Bladder Sparing

PHASE2CompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

July 13, 2018

Primary Completion Date

February 16, 2024

Study Completion Date

March 7, 2024

Conditions
Bladder Cancer
Interventions
DRUG

Nivolumab

Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days).

DRUG

Gemcitabine

Gemcitabine 1000mg/m\^2 will be administered on Days 1 and 8 for four 21-day cycles.

DRUG

Cisplatin

Cisplatin 70mg\^m2 will be administered on Day 1 for four 21-day cycles.

Trial Locations (7)

10029

Icahn School of Medicine: Tisch Cancer Institute at Mount Sinai Medical Center, New York

19104

Penn Medicine Abramson Cancer Center, Philadelphia

53705

University of Wisconsin, Madison

84112

Huntsman Cancer Institute University of Utah, Salt Lake City

90033

Univerity of Southern California, Los Angeles

91010

City of Hope, Duarte

97239

Oregon Health & Science University, Portland

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

Icahn School of Medicine at Mount Sinai

OTHER

lead

Matthew Galsky

OTHER