Trimodal Therapy Plus Atezolizumab in Muscle-invasive Bladder Cancer

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study ID
NCT03620435
Phase
PHASE2
Status
Unknown

Conditions

  • Safety Issues

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab (1200mg iv, every 3 weeks) administered concurrently with TMT and adjuvant for up to one year

Study Details

This is a single arm phase II trial to (1) evaluate safety and toxicity profile of intravenous Atezolizumab (anti-PDL-1) administered in combination with TMT in patients with MIBC, (2) To determine the loco-regional control rate (LCR) of TMT combined with PDL-1 blockade.

Key Dates

Start date
May 1, 2018
Status verified
Aug 2018
Primary completion
May 30, 2020
Completion
Dec 30, 2020

Study Design

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

Arms

  • Experimental: atezolizumab
    Atezolizumab will be given during trimodal therapy, and every 3 weeks for 16 cycles or until disease progression or unacceptable toxicity.

Primary Outcome Measure

Safety profile of intravenous Atezolizumab (anti-PDL-1) administered in combination with TMT in patients with MIBC [ Time Frame: 2-2.5 years ]

Central Contacts

Related Studies