Assessment of Efficacy and Safety of Durvalumab Plus BCG Compared to the Standard Therapy With BCG in Non-muscle Invasive Bladder Cancer

Sponsor
AstraZeneca
Study ID
NCT03528694
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Non-muscle-invasive Bladder Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab (MEDI4736) — BIOLOGICAL
    Investigational product
  • Bacillus Calmette-Guerin (BCG) — BIOLOGICAL
    Standard of care

Study Details

This is a randomized, open-label, multi-center, global, phase III study to determine the efficacy and safety of Durvalumab + BCG combination therapy in the treatment of patients with non-muscle-invasive bladder cancer

Key Dates

Start date
May 14, 2018
Status verified
Apr 2026
Primary completion
Apr 3, 2025
Completion
Oct 3, 2028

Study Design

Enrollment
1,018 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab plus BCG (induction + maintenance)
    Durvalumab (MEDI4736) plus Bacillus Calmette-Guerrin (BCG) combination therapy
  • Experimental: Durvalumab plus BCG (induction only)
    Durvalumab (MEDI4736) plus Bacillus Calmette-Guerrin (BCG) combination therapy
  • Active Comparator: BCG treatment (Standard of care therapy)
    Bacillus Calmette-Guerrin (BCG) standard of care treatment

Primary Outcome Measure

The efficacy of Durvalumab + BCG (induction plus maintenance) combination therapy compared to SoC in terms of Disease free survival (DFS) in patients with NMIBC [ Time Frame: Up to 4 years ]

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