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

NCT05120622 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2023-10-31

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Tremelimumab

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.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Peter Black · University of British Columbia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2022-05-01
Completion
2022-05-01
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05120622 on ClinicalTrials.gov