Trial of Local Cystoscopic Injection of Tremelimumab Plus Systemic Durvalumab for High Risk Non-Muscle Invasive Bladder Cancer

Sponsor
University of British Columbia
Study ID
NCT05120622
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

  • Bladder Cancer
  • Durvalumab
  • High-Risk Cancer
  • Non-muscle Invasive
  • Tremelimumab

Eligibility Criteria

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

Interventions

  • Tremelimumab — DRUG
    Tremelimumab 25 mg / 50 mg / 75 mg local cystoscopic injection into bladder wall at or adjacent to site of prior tumour resection (dose divided into 4 injection sites), administered 6 and 3 weeks before radical cystectomy. Durvalumab 1500mg via IV infusion administered 6 and 3 weeks before radical cystectomy.

Study Details

We will conduct a Phase I trial testing whether local cystoscopic injection of tremelimumab into the bladder wall in combination with systemic administration of durvalumab in localized bladder cancer will stimulate an effective anti-tumour immune response with minimal systemic immune response and clinical toxicity.

Key Dates

Start date
Sep 1, 2021
Status verified
Oct 2023
Primary completion
May 1, 2022
Completion
May 1, 2022

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tremelimumab
    Patients who will receive local cystoscopic injection of tremelimumab into the bladder wall in combination with systemic administration of durvalumab

Primary Outcome Measure

Number of participants with grade 3 adverse events related to tremelimumab [ Time Frame: 60 months ]

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