NCT04106115 DURvalumab in Combination With S-488210/S-488211 vAccine in Non-muscle Invasive Bladder CancEr
| NCT ID | NCT04106115 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University College, London |
| Condition | Bladder Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2022-03-25 |
| Primary Completion | 2025-05-31 |
Trial Parameters
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Brief Summary
DURANCE is a two part, phase Ib/II, multi-centre study to assess the safety and activity of S-488210/S-488211 in combination with durvalumab, in patients with non-muscle invasive bladder cancer (NMIBC).
Eligibility Criteria
Inclusion Criteria: 1. Histologically proven high risk non-muscle invasive bladder cancer (NMIBC) 2. Adequate archival tissue sample available for histological assessment (date sample taken must be within 6 months of planned start of treatment) 3. Predominant histologic component (\> 50%) must be urothelial (transitional cell) carcinoma 4. Bacillus Calmette-Guerin (BCG) unresponsive disease or are intolerant of BCG therapy 5. Refused or deemed clinically inappropriate for radical cystectomy 6. ≥18 years of age 7. Body weight \>30 kg 8. World Health Organisation (WHO) performance status 0-1 9. Must have undergone each of the following procedures within 8 weeks of registration: * Complete excision of all papillary disease (T1/TaHG) and demonstration of no muscle invasive disease in the resected specimens (muscle must be present in the tumour sample) * Bladder 'Mapping biopsies' taken * CT of the chest * CT Urogram or MRI of the abdomen and pelvis (if CT is not possible) 10. Adequate haem
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