At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Durvalumab (drug), S-488210/S-488211 (biological)
- How long the study runs
- Study runs about 126 months (dates as stated)
- About the drug or intervention
- Durvalumab — drug: 1500 mg IV infusion every 4 weeks for up to 7 doses · S-488210/S-488211 — biological: 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
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 52
- Started
- 2022-03-25
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for bladder cancer
- • Phase1/Phase2 - 52 participants
- • 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)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with bladder cancer
Where?
- • Cambridge - Cambridge University NHS FT
- • London - Guy's and St Thomas' NHS Foundation Trust
- • London - Royal Free London NHS FT
- • London - The Royal Marsden NHS Foundation Trust
- • +3 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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).
More detail
DURANCE is a registered, phase Ib/II study in patients with surgically debulked bacillus Calmette-Guerin (BCG) unresponsive (resistant or relapsing) or intolerant non-muscle invasive bladder cancer (NIMBC). Patients will receive up to 24 weeks of durvalumab (a PD-L1 immune checkpoint inhibitor) in combination with S-488210/S-488211 (a 5-peptide cancer vaccine). Durvalumab will be given as 1500 mg IV infusion every 4 weeks for up to 7 doses, in combination with S-488210/S-S488211 which will be administered as two subcutaneous injections of S-488210/Montanide and S-488211/Montanide starting the day after the first durvalumab dose, then weekly for 6 doses and every 2 weeks for a further 9 doses (up to a maximum of 16 doses). All patients must have a cystoscopy at the end of week 12 (from start of trial treatment) for disease evaluation and to assess suitability to continue trial treatment. Patients with complete response, as shown from the cystoscopy, may continue treatment for up to 24 weeks in the absence of progressive disease, unacceptable toxicity or withdrawal of consent; all other patient will be withdrawn from further trial treatment. The phase Ib part of the DURANCE study will look to assess the safety and tolerability of the treatment combination of durvalumab + S-488210/S-488211 by reviewing Dose Limiting Toxicities (DLTs) which have at least a reasonable possibility of being related to the trial treatments (durvalumab and/or S-488210/S-488211). Up to 14 evaluable patients will be registered into phase Ib and provided the DLTs do not exceed the DLT thresholds defined in the trial protocol, the trial will proceed to the expansion phase of the study (phase 2). In phase 2 the trial will look to assess the disease free survival rate at 1 year following start of treatment.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ undergone each of the following procedures within 8 weeks of registration:
Treatments you must NOT have had:
- ✗ systemic corticosteroid therapy (\>10 mg daily prednisolone equivalent)
What the study is looking for
- ✓Histologically proven high risk non-muscle invasive bladder cancer (NMIBC)
- ✓Adequate archival tissue sample available for histological assessment (date sample taken must be within 6 months of...
- ✓Predominant histologic component (\> 50%) must be urothelial (transitional cell) carcinoma
- ✓Bacillus Calmette-Guerin (BCG) unresponsive disease or are intolerant of BCG therapy
- ✓Refused or deemed clinically inappropriate for radical cystectomy
Who cannot take part
- ✗Inflammatory bowel disease (e.g. colitis or Crohn's disease)
- ✗Diverticulitis (with the exception of diverticulosis)
- ✗Systemic lupus erythematous (SLE)
- ✗Sarcoidosis syndrome
- ✗Wegener syndrome (granulomatosis with polyangitis, Grave's disease, rheumatoid arthritis, hypophysitis, uveitis, etc.)
See the full criteria
Where Is This Study? (7 UK sites)
Cambridge University NHS FT
Cambridge, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
Royal Free London NHS FT
London, United Kingdom
The Royal Marsden NHS Foundation Trust
London, United Kingdom
University College London Hospital NHS Foundation Trust
London, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825The Christie NHS Foundation Trust
Manchester, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
How to Get in Touch
Madison Williams
Sponsor contactCONTACT
Rubina Begum
Sponsor contactCONTACT
