Radiation and Durvalumab Immunotherapy As Neoadjuvant Treatment for MIBC

Sponsor
Ottawa Hospital Research Institute
Study ID
NCT04543110
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Durvalumab prior to Radical Cystectomy in Patients With Muscle-Invasive Bladder Carcinoma
  • Immune Modulating Radiation — RADIATION
    Neoadjuvant Immune-Modulating Radiation prior to Radical Cystectomy in Patients With Muscle-Invasive Bladder Carcinoma

Study Details

This study assesses the effect of sequential radiation and durvalumab immunotherapy given as treatment prior to surgery with radical cystectomy for bladder cancer.

Key Dates

Start date
Jan 29, 2021
Status verified
Mar 2023
Primary completion
Oct 31, 2023
Completion
Nov 30, 2024

Study Design

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

Arms

  • Experimental: Single Arm
    Immune-Modulating Radiation with Durvalumab prior to Radical Cystectomy in Patients With Muscle-Invasive Bladder Carcinoma

Primary Outcome Measure

Pathological Complete Response (pCR) Rate [ Time Frame: Up to 2 years ]

Central Contacts

Related Studies