Phase II Study Comparing Chemotherapy Alone to Chemotherapy Plus Durvalumab for Bladder Cancer with Lymph Node Involvement

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05137262

Provider View

This clinical trial is testing whether adding the immunotherapy drug durvalumab to standard chemotherapy can improve treatment outcomes for patients with bladder cancer that has spread to nearby lymph nodes. The study will involve 60 patients who will be randomly assigned to receive either chemotherapy alone or chemotherapy with durvalumab.

Patient Parameters

Program Overview

This study is exploring whether adding the immunotherapy drug durvalumab to standard chemotherapy can help control bladder cancer that has spread to lymph nodes in the pelvis. The trial will include 60 patients who will be randomly assigned to receive either the standard chemotherapy treatment or the same treatment with durvalumab. Durvalumab will be given every 4 weeks for up to a year or until the cancer returns. Tissue samples will be collected before treatment and during surgery to help researchers understand how the treatment works. Blood and urine samples will also be collected at various times to study the effects of the treatment.

Description

The main goal of this study is to see if adding durvalumab to chemotherapy can lead to a complete response, meaning no signs of cancer, in patients with bladder cancer that has spread to lymph nodes. Researchers will also look at how many patients can have surgery after treatment, how long patients stay cancer-free, and overall survival rates. The study will also evaluate the safety of the treatment combination and any side effects.

Patients will need to provide tissue samples from the bladder and lymph nodes before starting treatment. Blood and urine samples will be collected at different times to help researchers understand the treatment's effects. The study will also explore how changes in the immune system and cancer cells relate to treatment outcomes.

Eligibility Criteria

Inclusion Criteria

  • Must have bladder cancer that has spread to lymph nodes in the pelvis.
  • Must agree to provide tissue samples from the bladder and lymph nodes before treatment.
  • Must be 18 years or older.
  • Must have a lymph node that can be biopsied.
  • Must be in good overall health with a performance status of 0 or 1.
  • Must have a life expectancy of at least 12 weeks.
  • Must weigh more than 30 kg.
  • Must have a heart function of at least 50%.
  • Must have adequate organ function, including specific blood counts and kidney and liver function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 90 days after treatment.
  • Must be able to understand and sign informed consent.
  • Must be willing to comply with study visits and procedures.

Exclusion Criteria

  • Cancer has spread beyond the pelvis or to other organs.
  • Significant nerve damage or hearing loss.
  • Severe heart failure.
  • Active infections like Hepatitis B, Hepatitis C, or HIV.
  • Use of immunosuppressive medication recently.
  • Previous treatment with similar immunotherapy drugs.
  • Autoimmune diseases requiring treatment in the past 2 years.
  • History of organ transplant.
  • Recent live vaccine.
  • Active infections requiring IV antibiotics.
  • Recent heart attack or stroke.
  • Other serious medical conditions.
  • Another active cancer requiring treatment.
  • Recent chemotherapy or immunotherapy.
  • Allergic reactions to study drugs.
  • Pregnant or breastfeeding women.
  • Inability to use effective contraception.

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