Efficacy of Atezolizumab Concurrent With Radiotherapy in Patients With Muscle-invasive Bladder cáncer

Sponsor
Spanish Oncology Genito-Urinary Group
Study ID
NCT04186013
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Atezolizumab Injection [Tecentriq] — DRUG
    intravenous infusion of 1.200 mg of Atezolizumab administered intravenously every 3 weeks for a total of 6 doses
  • External Beam Radiation Therapy (EBRT) — RADIATION
    60 Gy of radiotherapy in 30 fractions overs 6 weeks at 2 Gy/day

Study Details

Open, multicentre, phase II trial of atezolizumab with concurrent normofractionated radiotherapy in patients with localized muscle-invasive bladder cancer treated with a selective multimodality bladder conservative approach.

Key Dates

Start date
Sep 18, 2019
Status verified
Oct 2022
Primary completion
Feb 28, 2027
Completion
May 31, 2027

Study Design

Enrollment
39 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental arm
    Atezolizumab 1200 mg intravenous infusion every 3 weeks for a total of 6 doses combined with External Beam Radiation Therapy (EBRT) (dosage: 60 Gy in 30 fractions overs 6 weeks at 2Gy/day)

Primary Outcome Measure

Pathological complete response [ Time Frame: After the end of the treatment (16 weeks) ]

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