Enfortumab Vedotin Plus Pembrolizumab for the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology

PHASE2RecruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

September 26, 2023

Primary Completion Date

December 16, 2026

Study Completion Date

December 16, 2027

Conditions
Bladder Squamous Cell CarcinomaLocally Advanced Bladder CarcinomaMalignant Renal Pelvis NeoplasmMalignant Ureter NeoplasmMalignant Urethral NeoplasmMetastatic Bladder CarcinomaStage III Bladder Cancer AJCC v8Stage IV Bladder Cancer AJCC v8Unresectable Bladder CarcinomaUrachal AdenocarcinomaBladder Adenocarcinoma
Interventions
PROCEDURE

Biospecimen Collection

Undergo collection of blood

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Enfortumab Vedotin

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Pembrolizumab

Given IV

OTHER

Questionnaire Administration

Ancillary studies

Trial Locations (4)

30303

RECRUITING

Grady Health System, Atlanta

30308

RECRUITING

Emory University Hospital Midtown, Atlanta

30322

RECRUITING

Emory University Hospital/Winship Cancer Institute, Atlanta

30342

RECRUITING

Emory Saint Joseph's Hospital, Atlanta

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Seagen Inc.

INDUSTRY

collaborator

Astellas Pharma Inc

INDUSTRY

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Emory University

OTHER

NCT05756569 - Enfortumab Vedotin Plus Pembrolizumab for the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology | Biotech Hunter | Biotech Hunter