SUBurothelial DUrvalumab injEction-1 (SUBDUE-1)

Phase 1

Completed

• Conditions: Cancer - Bladder; Muscle invasive or high risk non muscle invasive bladder cancer

• Registration Number: ACTRN12620000063910
• Lead Sponsor: South Metropolitan Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-24
• Study Completion: 2022-08-09
• Last Update Posted: 8 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Study population: Participants with either muscle invasive bladder cancer or high-risk non-muscle invasive (T1, high grade Ta, carcinoma in-situ) bladder tumours scheduled for cystectomy, who have refused or are ineligible for systemic neo-adjuvant chemotherapy.

Inclusion criteria;
1. Age equal to or greater than 18 years
2. ECOG performance less than 2
3. Life expectancy equal to or greater than 6 months
4. Adequate organ and marrow function

Exclusion Criteria

1. Patients who have received neo-adjuvant chemotherapy
2. Any concurrent cancer therapy of the same biological intent that may interact with durvalumab.
3. Participation in another clinical study with an investigational product during the last 28 days
4. Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade equal to or greater than 2 from previous anticancer therapy
5. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of sub-urothelial durvalumab
6. Major surgical procedure within 28 days prior to administration of durvalumab, excluding trans-urethral resection of bladder tumour
7. History of allogenic organ transplantation
8. Active or prior documented autoimmune or inflammatory disorders
9. History of another primary malignancy within the last 5 years, excluding non-melanomatous skin cancer
10. History of active primary immunodeficiency
11. Active tuberculosis, hepatitis B, hepatitis C
12. Current or prior use of immunosuppressive medication within 14 days before the first dose
of durvalumab
13. Receipt of live attenuated vaccine within 30 days prior to administration of sub-urothelial
durvalumab. Patients should not receive live vaccine up to 30 days after durvalumab
administration
14. Female patients who are pregnant or breastfeeding or male or female patients of
reproductive potential who are not willing to employ effective birth control from screening
to 90 days after the last dose of durvalumab
15. Known allergy or hypersensitivity to durvalumab

Study & Design

• Study Type: Interventional
• Study Design: Not specified