Study on BCG and Durvalumab Combination for Adults with High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05943106

Provider View

This clinical trial is testing a combination of BCG and durvalumab to see if it is safe and effective for adults in the U.S. with high-risk non-muscle-invasive bladder cancer who have not received prior BCG treatment.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of combining BCG and durvalumab in adults with high-risk non-muscle-invasive bladder cancer (NMIBC) who have not previously received BCG treatment. Participants will undergo screening up to 4 weeks before starting the treatment, receive the treatment for up to 24 months, and have a follow-up period for safety and survival monitoring for up to 42 months from the start of the study.

Description

This is a Phase IIIb study conducted in the U.S. to explore the effects of combining BCG and durvalumab in patients with high-risk non-muscle-invasive bladder cancer (NMIBC). The study is open-label, meaning both the researchers and participants know what treatment is being given, and single-arm, meaning all participants receive the same treatment.

Participants will be screened up to 4 weeks before starting the treatment. The treatment phase lasts up to 24 months, followed by a 3-month safety follow-up. Participants will continue to be monitored for survival for up to 42 months from the start of the study. The study aims to determine if this combination therapy is safe and effective in treating high-risk NMIBC.

Eligibility Criteria

Inclusion Criteria

  • Have not received BCG treatment before or stopped BCG treatment more than 3 years ago.
  • Have a confirmed diagnosis of high-risk bladder cancer that is confined to the inner layers of the bladder.
  • Have had all visible bladder tumors removed before joining the study, with surgery done no more than 4 months before enrollment.
  • Have not received radiation therapy for bladder cancer.
  • Have a life expectancy of at least 12 weeks.
  • Have adequate organ and bone marrow function.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have not received immune therapy for cancer before.
  • Be a candidate for BCG treatment.
  • Have a high-risk tumor, defined as T1, high-grade/G3, or carcinoma in situ (CIS).

Exclusion Criteria

  • Have muscle-invasive, advanced, or metastatic bladder cancer.
  • Have a tumor with more than 50% of certain rare cell types or other than urothelial tumors.
  • Have evidence of cancer spreading to blood vessels in the bladder, unless BCG is the only treatment option.
  • Need immediate bladder removal surgery.
  • Have a known contraindication to BCG treatment.
  • Have bladder cancer outside the bladder lining.
  • Have a history of organ or stem cell transplantation.
  • Have active or past autoimmune or inflammatory disorders, except stable hypothyroidism.
  • Have a history of primary immune deficiency.
  • Have active infections like hepatitis B, C, or HIV.
  • Have used immunosuppressive medication within 14 days before the first dose of durvalumab.
  • Are pregnant or breastfeeding, or not using effective birth control if of reproductive potential.
  • Are receiving other cancer treatments or have uncontrolled illnesses.
  • Have a history of another primary cancer, unless treated and inactive for at least 2 years, or certain skin or prostate cancers without active disease.
  • Have received potent systemic immune-stimulating agents before.

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