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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT05756569
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Bladder Adenocarcinoma
  • Bladder Squamous Cell Carcinoma
  • Locally Advanced Bladder Carcinoma
  • Malignant Renal Pelvis Neoplasm
  • Malignant Ureter Neoplasm
  • Malignant Urethral Neoplasm
  • Metastatic Bladder Carcinoma
  • Stage III Bladder Cancer AJCC v8
  • Stage IV Bladder Cancer AJCC v8
  • Unresectable Bladder Carcinoma
  • Urachal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Enfortumab Vedotin — DRUG
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

This phase II trial tests how well enfortumab vedotin (EV) and pembrolizumab works in treating patients with bladder cancer of variant histology (a group of less common types of bladder cancer) that have spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. Enfortumab attaches to a protein called nectin-4 on cancer cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving enfortumab vedotin and pembrolizumab may kill more tumor cells in patients with locally advanced or metastatic bladder cancer of variant histology.

Key Dates

Start date
Sep 26, 2023
Status verified
Jul 2025
Primary completion
Dec 16, 2026
Completion
Dec 16, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (enfortumab vedotin, pembrolizumab)
    Patients receive enfortumab vedotin IV and pembrolizumab IV on study. Patients also undergo CT scan or MRI, and collection of blood throughout the trial.

Primary Outcome Measure

Overall response rate [ Time Frame: Up to 2 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Emory Saint Joseph's HospitalAtlantaGeorgia30342
Wilena Session
[email protected]
404-778-4005
Jacqueline Brown, MD (PRINCIPAL_INVESTIGATOR)
Emory University Hospital MidtownAtlantaGeorgia30308
Wilena Session
[email protected]
404-778-4005
Jacqueline Brown, MD (PRINCIPAL_INVESTIGATOR)
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322
Wilena Session
[email protected]
404-778-4005
Jacqueline Brown, MD (PRINCIPAL_INVESTIGATOR)
Grady Health SystemAtlantaGeorgia30303
Wilena Session
[email protected]
404-778-4005
Jacqueline Brown, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By research site
Emory Saint Joseph's Hospital· Atlanta, GAEmory University Hospital Midtown· Atlanta, GAEmory University Hospital/Winship Cancer Institute· Atlanta, GAGrady Health System· Atlanta, GA

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