Actively Recruiting
DURvalumab in Combination With S-488210/S-488211 vAccine in Non-muscle Invasive Bladder CancEr
Led by University College, London · Updated on 2024-12-04
64
Participants Needed
5
Research Sites
374 weeks
Total Duration
On this page
Sponsors
U
University College, London
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
DURvalumab in Combination With S-488210/S-488211 vAccine in Non-muscle Invasive Bladder CancEr
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed high-risk non-muscle invasive bladder cancer (NMIBC)
- Available tissue sample taken within 6 months before planned treatment start
- Urothelial (transitional cell) carcinoma is the main tumor type (> 50%)
- Disease unresponsive or intolerant to Bacillus Calmette-Guerin (BCG) therapy
- Refused or not suitable for radical cystectomy
- Age 18 years or older
- Body weight over 30 kg
- WHO performance status 0 or 1
- Completed removal of all papillary tumors and no muscle invasive disease in samples within 8 weeks before registration
- Bladder mapping biopsies done within 8 weeks before registration
- CT chest and CT Urogram or MRI abdomen and pelvis done within 8 weeks before registration
- Adequate blood counts: hemoglobin ≥9.0 g/dL, neutrophils ≥1.5 x 10^9/L, platelets ≥100 x 10^9/L
- Normal INR ≤1.5 and APTT ≤1.5 x upper limit normal (unless on stable anticoagulation)
- Liver function within limits: bilirubin ≤1.5 x ULN (≤3.0 x ULN if Gilbert's syndrome), AST or ALT ≤2.5 x ULN
- Kidney function with creatinine clearance ≥40 mL/min
- Life expectancy of at least 6 months
- Able and willing to give informed consent
- Use of highly effective contraception for patients of child-bearing potential during and 90 days after treatment
- Female patients not pregnant, with negative pregnancy test if pre-menopausal
- Willing and able to comply with study visits, treatment, and testing
You will not qualify if you...
- History of autoimmune or inflammatory diseases including inflammatory bowel disease, diverticulitis (except diverticulosis), systemic lupus erythematous, sarcoidosis, Wegener syndrome, rheumatoid arthritis, hypophysitis, uveitis, unless inactive for 5 years and approved by investigators
- Previous allogeneic stem cell or organ transplantation
- Prior treatment with anti-PD-1, PD-L1, CTLA-4 antibodies or other novel immune-oncology agents
- Active invasive cancers within past 2 years except non-melanoma skin cancer
- History or evidence of serious lung diseases including idiopathic pulmonary fibrosis or active pneumonitis
- Symptomatic interstitial lung disease
- QTcF interval over 470 ms confirmed by repeat ECGs
- Risk factors for bowel perforation such as recent diverticulitis or mechanical GI obstruction
- Unresolved severe side effects from prior cancer therapy except alopecia, vitiligo, or lab abnormalities
- Recent anti-cancer therapy or experimental drugs within 30 days or 5 half-lives
- Participation in another interventional clinical trial
- Severe uncontrolled diseases or lab abnormalities making participation unsafe
- Recent therapeutic antibiotics use unless prophylactic
- Psychiatric or other disorders impairing consent or compliance
- History of leptomeningeal carcinomatosis
- Active tuberculosis infection
- Recent systemic corticosteroid or immunosuppressive medication use
- Recent live attenuated vaccine administration
- Significant uncontrolled diseases increasing risk or affecting study
- Major surgery within 28 days prior to treatment (except cystoscopy and biopsies)
- Significant cardiovascular diseases including recent myocardial infarction, unstable angina, or arrhythmias
- Uncontrolled type 1 diabetes mellitus
- Uncontrolled adrenal insufficiency
- Active hepatitis B or C infection
- Known active immune deficiencies including uncontrolled HIV/AIDS
- Pregnant or breastfeeding women
- Allergy to study drugs or excipients
- Prior participation in durvalumab studies
- Blood donation during study and 90 days after last dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
Actively Recruiting
2
The Royal Marsden NHS Foundation Trust
London, United Kingdom
Actively Recruiting
3
University College London Hospital NHS Foundation Trust
London, United Kingdom
Actively Recruiting
4
The Christie NHS Foundation Trust
Manchester, United Kingdom
Actively Recruiting
5
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
Actively Recruiting
Research Team
M
Madison Williams
CONTACT
R
Rubina Begum
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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