Atezolizumab Plus One-year BCG Bladder Instillation in BCG-naive High-risk Non-muscle Invasive Bladder Cancer Patients

Sponsor
UNICANCER
Study ID
NCT03799835
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BCG — DRUG
    Intravesical administration OncoTice wil be used only under two conditions : BCG Medac® unavailable and the patient has received at minimum one instillation of BCG Medac®
  • Atezolizumab — DRUG
    IV perfusion

Study Details

This is an open-label, randomized, multicentric study in patients with high-risk non-muscle invasive bladder cancer who had never received BCG for this disease. The primary objective is to evaluate the efficacy of atezolizumab as measured by Event-Free survival.

Key Dates

Start date
Jan 17, 2019
Status verified
Dec 2024
Primary completion
Jun 30, 2025
Completion
Oct 31, 2028

Study Design

Enrollment
517 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A : control arm
    BCG therapy only BCG therapy will be administered in two phases: * induction phase: weekly administration of full dose of BCG intravesically up to 6 weeks, starting on the day of the first induction instillation (D1) * maintenance phase: full-dose BCG administered once per week for 3 weeks, at week 13 (i.e. 3 months after the first BCG instillation of induction, D1), at week 26 (6 months from D1) and week 52 (12 months from D1).
  • Experimental: Arm B: experimental arm
    BCG therapy + administration of atezolizumab 1. BCG therapy will be administered in two phases: * induction phase: weekly administration of full dose of BCG intravesically up to 6 weeks, starting on the day of the first induction instillation (D1) * maintenance phase: full-dose BCG administered once per week for 3 weeks, at week 13 (i.e. 3 months after the first BCG instillation of induction, D1), at week 26 (6 months from D1) and week 52 (12 months from D1). 2. atezolizumab is administered by IV infusion every 3 weeks (21 \[± 2\] days) for 1 year (18 cycles as a maximum).

Primary Outcome Measure

Event-Free Survival [ Time Frame: 5 years ]

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