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).
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
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patient will be withdrawn from further trial treatment.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
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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