CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 52 target
Drug / intervention
Durvalumab +1 moredrug
Likely dose
Durvalumab 1500 mgfrom record
Key inclusion· 11
  • ✓Histologically proven high risk non-muscle invasive bladder cancer (NMIBC)
  • ✓Predominant histologic component (>50%) must be urothelial (transitional cell) carcinoma
  • ✓BCG unresponsive disease or intolerant of BCG therapy
  • ✓Refused or deemed clinically inappropriate for radical cystectomy
Key exclusion· 26
  • ✕History of autoimmune or inflammatory disease including IBD, diverticulitis, SLE, sarcoidosis, Wegener syndrome, rheumatoid arthritis
  • ✕Prior allogeneic stem cell or solid organ transplantation
  • ✕Prior treatment with anti-PD-1, PD-L1, CTLA-4, or other novel immune-oncology agents
  • ✕Active invasive malignancy in previous 2 years excluding non-melanoma skin cancer

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04106115
NCT04106115Phase 1RecruitingHigh Momentum
Long Recruiting
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A Phase Ib/II Study to Assess the Safety and Activity of DURvalumab (MEDI4736) in Combination With S-488210/S-488211 vAccine in Non-muscle Invasive Bladder CancEr

University College, London·interventional·Posted Sep 26, 2019·Updated Jun 11, 2026

In Brief

A Phase 1 clinical trial evaluating Durvalumab and S-488210/S-488211 for Bladder Cancer. Currently recruiting, targeting 52 participants across 7 sites.

Signals

Enrolling ahead of pace

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder Cancer
CountriesUnited Kingdom
CollaboratorsAstraZeneca, Shionogi

Timeline

Phase 1Recruiting
20202021202220232024202520262027202820292030203120322033
First PostedSep 26, 2019
Enrollment StartMar 25, 2022
Primary CompletionMar 30, 2027
Study CompletionSep 30, 2032
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 6.8 years agoPrimary completion in 9 months

Arms & Interventions

Durvalumab + S-488210/S-488211experimental

Trial treatment for up to 24 weeks of Durvalumab (1500 mg IV infusion every 4 weeks for up to 7 doses) in combination with S-488210/S-488211 vaccine (given as 2 subcutaneous injections of S-488210/Montanide and S-488211/Montanide starting day after first durvalumab dose, then weekly for the first 6 weeks, and then every 2 weeks for a further 9 doses).

Drug: DurvalumabBiological: S-488210/S-488211

Interventions

Durvalumabdrug

1500 mg IV infusion every 4 weeks for up to 7 doses

S-488210/S-488211biological

S-488210/S-488211 is given as a 1 mL subcutaneous (SC) injection of S-488210/Montanide emulsion and a 1 mL SC injection of S-488211/Montanide emulsion starting the day after first dose of durvalumab and continuing weekly for 6 doses and then every 2 weeks for a further 9 doses