BCG in Combination With Durvalumab in Adult BCG-naïve, High-risk NMIBC Participants

Conditions

• Non-Muscle- Invasive Bladder Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• Durvalumab — BIOLOGICAL
  Participants will receive Durvalumab via intravenous infusion from Week 1 for 13 cycles every 4 weeks (q4w) for maximum 12 months.
• BCG — BIOLOGICAL
  Participants will receive BCG via intravesical as induction weekly for 6 weeks starting at Week 1, Day 1 and subsequently for maintenance for 3 weekly doses up to 3, 6, 12, 18, and 24 months, at the physician's discretion as Standard of care.

Study Details

The purpose of this study is to assess the safety, tolerability, and efficacy profile of durvalumab + BCG (induction and maintenance) combination therapy in adult United States participants with a histologically confirmed diagnosis of high-risk non-muscle-invasive bladder cancer (NMIBC), who have received no prior systemic therapy for NMIBC, and who are BCG-naïve.

Key Dates

Start date

Aug 11, 2023

Status verified

Apr 2026

Primary completion

Jun 16, 2025

Completion

Mar 31, 2027

Study Design

Enrollment

100 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Durvalumab + BCG
  Participants will receive Durvalumab for 13 cycles every 4 weeks (q4w) for a maximum 12 months. All participants will receive BCG (supplied by the site) intravesically, as induction weekly for 6 weeks. Patients will subsequently receive BCG for maintenance for 3 weekly doses at 3,6,12,18, and up to 24 months, at the physician's discretion.

Primary Outcome Measure

Incidence of Grade 3 or 4 Possibly related adverse events (PRAEs) [ Time Frame: From the date of the first dose of study treatment (Day 1) until 6 months after the initiation of study treatment ]

Locations (19)

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