Study on Enfortumab Vedotin with Radiation for Locally Advanced Bladder Cancer (CONSOLIDATE)

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT06434350

Provider View

This clinical trial is exploring whether combining the drug enfortumab vedotin with radiation therapy can help control locally advanced bladder cancer. The study aims to assess the safety, effectiveness, and impact on quality of life of this treatment combination.

Patient Parameters

Program Overview

The purpose of this study is to find out if using enfortumab vedotin together with radiation therapy can better manage locally advanced bladder cancer. Researchers are looking at how long patients live without the cancer getting worse, how safe the treatment is, and how it affects patients' quality of life. They are also interested in seeing if the treatment can prevent the cancer from spreading and what side effects it might cause.

Description

This study has several main goals:

  1. To see how long patients can live without their bladder cancer getting worse when treated with enfortumab vedotin and radiation therapy.
  2. To check if this treatment combination is safe and well-tolerated by patients.
  3. To evaluate how this treatment affects patients' overall quality of life.

The study also has additional goals:

  1. To find out how many patients are still alive 12 months after starting the study.
  2. To see if the cancer has spread to other parts of the body 12 months after starting the study.
  3. To identify any side effects related to the treatment.
  4. To determine if the treatment can prevent urinary problems.
  5. To explore if certain biological markers in blood and urine are linked to patient outcomes.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with bladder cancer, including specific types and stages.
  • Aged 18 years or older.
  • Able to perform daily activities with little or no assistance.
  • Meet specific blood test requirements, including:
    • Hemoglobin level of at least 9 g/dL.
    • Platelet count of at least 100,000 per microliter.
    • Kidney function with creatinine clearance of at least 30 mL/min.
    • Neutrophil count of at least 1500 per microliter.
  • Male and female participants must use effective birth control during the study and for 6 months after completing radiation therapy.
  • Eligible for local treatment of the cancer as determined by the study doctors.

Exclusion Criteria

  • Have certain autoimmune diseases like scleroderma or lupus that make radiation unsafe.
  • Have mental health or substance abuse issues that could interfere with the study.
  • Have cancer that has spread beyond the lymph nodes and cannot be treated with radiation.
  • Have had previous radiation therapy to the pelvic area.
  • Have ongoing significant side effects from previous cancer treatments.
  • Have uncontrolled diabetes with high blood sugar levels.
  • Have a life expectancy of less than 12 weeks.
  • Have nerve damage affecting movement or sensation.
  • Are receiving treatment for an active infection.
  • Have a history of hepatitis B or C, or HIV infection.
  • Require high doses of steroids or other immune-suppressing medications.
  • Have lung diseases like pulmonary fibrosis or pneumonitis.
  • Have had a stem cell or organ transplant.
  • Have active tuberculosis.
  • Are pregnant or planning to become pregnant during the study. Women of childbearing potential must have a negative pregnancy test before starting radiation therapy.

Locations

FACILITYZIPCITYSTATE
MD Anderson Cancer Center77030HoustonTexas

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