OncoMatch/Clinical Trials/NCT04106115
DURvalumab in Combination With S-488210/S-488211 vAccine in Non-muscle Invasive Bladder CancEr
Is NCT04106115 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including S-488210/S-488211 and Durvalumab for bladder cancer.
Treatment: Durvalumab · S-488210/S-488211 — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage NON-MUSCLE INVASIVE, TAHG
Excluded: Stage MUSCLE INVASIVE
Grade: high risk
Histologically proven high risk non-muscle invasive bladder cancer (NMIBC); Complete excision of all papillary disease (T1/TaHG) and demonstration of no muscle invasive disease in the resected specimens
Performance status
WHO 0–1
Prior therapy
Must have received: Bacillus Calmette-Guerin (BCG) therapy
BCG unresponsive disease or are intolerant of BCG therapy
Cannot have received: anti-PD-1 therapy
prior treatment with anti- PD-1, PD-L1 or CTLA-4 monoclonal antibody or other novel immune-oncology agent(s)
Cannot have received: anti-PD-L1 therapy
prior treatment with anti- PD-1, PD-L1 or CTLA-4 monoclonal antibody or other novel immune-oncology agent(s)
Cannot have received: anti-CTLA-4 therapy
prior treatment with anti- PD-1, PD-L1 or CTLA-4 monoclonal antibody or other novel immune-oncology agent(s)
Cannot have received: novel immune-oncology agent
prior treatment with anti- PD-1, PD-L1 or CTLA-4 monoclonal antibody or other novel immune-oncology agent(s)
Cannot have received: allogeneic stem cell transplant
prior allogeneic stem cell or solid organ transplantation
Cannot have received: solid organ transplant
prior allogeneic stem cell or solid organ transplantation
Cannot have received: anti-cancer therapy
Receipt of last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, embolisation, monoclonal antibodies) within 30 days prior to first dose of trial treatment
Cannot have received: experimental drug
Treatment with any experimental drug within 30 days or 5 half-lives (whichever is longer) of the first dose of trial treatment
Cannot have received: durvalumab (durvalumab)
Prior enrolment to, or treatment in a previous durvalumab clinical study, regardless of treatment arm assignment
Lab requirements
Blood counts
Haemoglobin ≥9.0 g/dL; Absolute neutrophil count ≥1.5 x 10^9/L (≥150,000 per mm3); Platelet count ≥100 x 10^9/L (≥100,000 per mm3); INR ≤1.5 and APTT ≤1.5 x ULN (applies only to patients not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose)
Kidney function
Measured creatinine clearance ≥40 mL/min or calculated creatinine clearance ≥40 mL/min using Cockcroft-Gault formula or by 24-hour urine collection
Liver function
Total bilirubin ≤1.5 X ULN (<3.0 x ULN for patients with Gilbert's syndrome); AST or ALT ≤2.5 x ULN
Cardiac function
QTcF value of >470 ms (if prolonged, confirm by 2 further ECGs each separated by at least 5 minutes)
Adequate haematological status: Haemoglobin ≥9.0 g/dL; Absolute neutrophil count ≥1.5 x 10^9/L (≥150,000 per mm3); Platelet count ≥100 x 10^9/L (≥100,000 per mm3); INR ≤1.5 and APTT ≤1.5 x ULN. Adequate liver function: Total bilirubin ≤1.5 X ULN (<3.0 x ULN for patients with Gilbert's syndrome); AST or ALT ≤2.5 x ULN. Adequate renal function: Measured creatinine clearance ≥40 mL/min or calculated creatinine clearance ≥40 mL/min using Cockcroft-Gault formula or by 24-hour urine collection. QTcF value of >470 ms.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify