Study on Risk-Enabled Therapy After Starting Enfortumab Vedotin and Pembrolizumab for Bladder Cancer

Sponsor: Fox Chase Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT07908979

Provider View

This clinical trial is exploring a new treatment approach for patients with muscle-invasive bladder cancer. It involves using two drugs, enfortumab vedotin and pembrolizumab, before surgery to see if they can help preserve the bladder while effectively managing the cancer.

Patient Parameters

Program Overview

The RETAIN-3 study is testing a new treatment strategy for patients with muscle-invasive bladder cancer. Participants will receive two drugs, enfortumab vedotin and pembrolizumab, before any surgery. After this treatment, doctors will assess the cancer using clinical tests and biomarkers to decide the next steps in treatment. This could include ongoing monitoring, additional therapy, surgery to remove the bladder, or a combination of chemotherapy and radiation. The goal is to see if this approach can help keep the bladder intact while still effectively treating the cancer.

Description

The RETAIN-3 study is a phase II clinical trial involving multiple centers. It is open-label, meaning both doctors and participants know what treatment is being given. The study focuses on patients with muscle-invasive bladder cancer, specifically those with a clinical stage of T2-T3N0M0. Participants will receive enfortumab vedotin and pembrolizumab before any surgery. After this initial treatment, doctors will use clinical tests and biomarkers to guide further treatment decisions. Options may include active monitoring, maintenance therapy, bladder removal surgery, or a combination of chemotherapy and radiation. The aim is to determine if this personalized approach can help preserve the bladder in some patients while still achieving good cancer control.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with primary or mostly urothelial carcinoma of the bladder, confirmed by a pathology report. Patients with some mixed histology are allowed, but not those with upper tract urothelial carcinoma.
  • Men with urothelial carcinoma of the prostatic urethra are eligible.
  • Evidence of cancer invading the muscle layer of the bladder.
  • Clinical stage T2-T3 N0M0 according to AJCC guidelines.
  • No signs of cancer in the lymph nodes based on imaging tests, unless a biopsy confirms no cancer in nodes larger than 1.5 cm.
  • No signs of cancer spread to other parts of the body (M0).
  • ECOG performance status of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Negative pregnancy test for women of childbearing potential within 72 hours before starting treatment.
  • Normal organ and bone marrow function.

Exclusion Criteria

  • Any presence of small cell cancer type.
  • Previous chemotherapy for muscle-invasive bladder cancer.
  • Uncontrolled diabetes with HbA1c greater than 8.5%.
  • Existing severe nerve damage.
  • Another active cancer that has progressed or required treatment in the last two years, except for certain skin cancers or in situ cervical cancer.
  • Participation in other experimental treatments within four weeks before the study.
  • Previous treatment with enfortumab vedotin.
  • Uncontrolled illnesses, including infections, heart failure, unstable chest pain, or psychiatric conditions that could affect study participation.
  • Pregnant women due to potential risks to the fetus.
  • HIV-positive patients on effective treatment with undetectable viral load are eligible.
  • Use of systemic steroids or immunosuppressive drugs within seven days before starting the study, except for certain low-dose or specific uses.
  • History of autoimmune diseases like lupus, rheumatoid arthritis, or multiple sclerosis.
  • Previous treatment with certain immune-targeting drugs or having had an organ transplant.
  • Recent use of immune-stimulating drugs within four weeks before the study.
  • Allergy to enfortumab vedotin, pembrolizumab, or any ingredients in these drugs.

Locations

FACILITYZIPCITYSTATE
Fox Chase Cancer Center - Philadelphia19111-2497PhiladelphiaPennsylvania

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