Actively Recruiting
Neoadjuvant Immune Checkpoint Inhibitor Treatment in Urothelial Cancer
Led by Queen Mary University of London · Updated on 2025-11-18
58
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
Sponsors
Q
Queen Mary University of London
Lead Sponsor
H
Hoffmann-La Roche
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is being carried out to see if the drug atezolizumab can reduce the size of tumours in patients with types of urothelial cancer before surgery. Atezolizumab is designed to stop a protein called PD-L1 (programmed death-ligand 1) being expressed on the cancer, allowing the immune system to recognise the tumour cells as foreign bodies and attack them. Atezolizumab has been shown to have activity in urothelial cancer which has spread. There two cohorts for this trial. One cohort will investigate the most common histological type of urothelial cancer (transitional cell carcinoma) outside the bladder, for example in the upper urinary tract. The other cohort will investigate rarer histological subtypes (such as such as squamous cell or adenocarcinoma) of urothelial cancer throughout the entire urinary system. This study will be recruiting patients from hospitals in the UK, France and Spain. If a patient is eligible for the study and decides to take part, they will receive up to two 3-weekly cycles of atezolizumab. 4-8 weeks after being enrolled, the patient will have an operation to remove the bladder (cystectomy) or the kidney, ureter and part of the bladder (nephroureterectomy or distal ureteral resection) as per normal practice. Following surgery, they will attend three hospital visits (4,12 and 24 weeks after surgery) and their disease progress/survival will be followed over the next 2 years. The clinical team will compare the patient's tumour tissue samples,scan results and blood results from before and after treatment with atezolizumab in order to see how well the drug works and if it is safe. Many of the procedures involved in this study are offered as standard care and participation in this trial will not delay surgery.
CONDITIONS
Official Title
Neoadjuvant Immune Checkpoint Inhibitor Treatment in Urothelial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathologically confirmed urothelial carcinoma in the bladder (T1 high grade to T4a) with mixed or rare subtypes for bladder cohort
- Histopathologically confirmed high grade or high risk upper urinary tract urothelial carcinoma for UTUC cohort
- Patients qualified for radical surgery (nephroureterectomy, distal ureter resection, or cystectomy) with curative intent
- Age 18 years or older
- Residual disease after transurethral resection or ureteroscopy
- N0 or M0 disease confirmed by CT or MRI within 4 weeks of registration
- Availability of representative tumor tissue samples for central testing
- Patients who refuse or are not suitable for neoadjuvant cisplatin-based chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Negative pregnancy test within 2 weeks of first treatment for females of childbearing potential
- Use of effective contraception for 90 days after last dose for females of childbearing potential
- Adequate blood counts and organ function within 4 weeks prior to first treatment, including ANC ≥1500 cells/μL, WBC >2500/μL, lymphocyte count ≥500/μL, platelet count ≥100,000/μL, hemoglobin ≥9.0 g/dL, liver enzymes ≤2.5 times upper normal limit, INR and aPTT ≤1.5 times upper normal limit if not on anticoagulation, and creatinine clearance ≥20 mL/min
You will not qualify if you...
- Pregnant or breastfeeding females
- Major surgery within 4 weeks prior to enrollment or planned during the study except diagnostic surgery
- Previous intravenous chemotherapy for urothelial cancer
- Prior allogeneic stem cell or organ transplant
- Previous treatment with anti-PD-1, anti-PD-L1, anti-CTLA-4, or CD137 agonists
- Use of oral or IV steroids within 14 days before study entry (except inhaled or physiologic doses)
- Therapeutic oral or IV antibiotics within 14 days before enrollment
- Live attenuated vaccine within 4 weeks prior to enrollment or planned during study
- Treatment with systemic immunostimulants within 4 weeks prior to enrollment
- Participation in another therapeutic clinical trial within 4 weeks prior to enrollment
- Significant uncontrolled diseases including severe liver disease, seizure disorders, or superior vena cava syndrome
- Other malignancies within 5 years except certain low-risk cancers
- Severe infections requiring hospitalization within 4 weeks prior to enrollment
- Significant cardiovascular disease including recent myocardial infarction or unstable angina
- History or evidence of pneumonitis or active pneumonitis on screening chest CT
- Uncontrolled type 1 diabetes mellitus
- Active hepatitis B or C infection
- Positive HIV test
- Active tuberculosis
- Gastrointestinal disorders affecting drug absorption
- Uncontrolled or symptomatic hypercalcemia
- History of autoimmune diseases except stable autoimmune hypothyroidism
- History of severe allergic reactions to antibodies or fusion proteins
- Known allergy to components of atezolizumab formulation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Barts and London Hospital NHS Trust
London, United Kingdom
Actively Recruiting
Research Team
A
ABACUS-2 Trial Coordinator
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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