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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University

About this trial

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.

Eligibility criteria

Qualifiers

Male or Female

Age >= 18 years

Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)

Metastatic disease or unresectable locally advanced disease

Disqualifiers

The neuroendocrine histology (small cell and large cell carcinomas) and non-epithelial bladder tumors (e.g. bladder sarcoma, carcinosarcoma, paraganglioma, melanoma, primary lymphoma, and lymphoepithelioma-like carcinoma) are excluded.

Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier [i.e. ongoing clinically significant toxicity (grade 2 or higher with the exception of alopecia) associated with prior treatment]

Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs

History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in study

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Computed Tomography
  • Enfortumab Vedotin
  • Magnetic Resonance Imaging
  • Pembrolizumab
  • Questionnaire Administration

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators

Emory University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Seagen Inc.

Collaborator

Astellas Pharma Inc

Collaborator

Merck Sharp & Dohme LLC

Collaborator