NCT06571708View on ClinicalTrials.gov

Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)

PHASE2RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

August 14, 2025

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2028

Conditions
Bladder CancerMuscle-Invasive Bladder Carcinoma
Interventions
DRUG

Gemcitabine

Gemcitabine 1000 mg/m\^2 IV

DRUG

Cisplatin

Cisplatin 70 mg/m\^2 IV or renally-dosed split-dose cisplatin 35 m/m\^2 IV

DRUG

Cemiplimab

Cemiplimab 350mg IV

DRUG

Fianlimab

Fianlimab 1600mg IV

Trial Locations (1)

10032

RECRUITING

Columbia University Irving Medical Center/ New York Presbyterian Hospital, New York

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Columbia University

OTHER

NCT06571708 - Gemcitabine/Cisplatin Plus Cemiplimab With or Without Fianlimab in Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT) | Biotech Hunter | Biotech Hunter