Phase Ib Feasibility Trial of Neoadjuvant Nivolumab/Lirilumab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

March 22, 2019

Primary Completion Date

November 27, 2020

Study Completion Date

October 5, 2022

Conditions
Bladder Cancer
Interventions
DRUG

Nivolumab

Nivolumab 480 mg intravenously (IV) over approximately 30 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.

DRUG

Nivolumab/Lirilumab

Nivolumab 480 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) with at least a 30 minute rest between infusions followed by lirilumab 240 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.

Trial Locations (8)

10029

Icahn School of Medicine at Mount Sinai, New York

10461

Montefiore Medical Center, The Bronx

22903

University of Virginia, Charlottesville

33612

Moffitt Cancer Center, Tampa

43210

Ohio State University Comprehensive Cancer Center, Columbus

75390

University of TX Southwestern, Dallas

97239

Oregon Health & Science University, Portland

98109

University of Washington, Seattle

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

PrECOG, LLC.

OTHER