Actively Recruiting
Comparing 3 vs 6 Cycles of Platinum-based Chemotherapy Prior to Maintenance Avelumab in Advanced Urothelial Cancer
Led by Queen Mary University of London · Updated on 2026-05-06
320
Participants Needed
3
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an adaptive, open-label, randomised phase II trial that aims to evaluate the impact of 3 vs 6 cycles of first-line platinum-based chemotherapy followed by maintenance avelumab in the quality of life of patients with locally advanced or metastatic urothelial cancer. Initially, 224 eligible and evaluable patients (112 in each arm) will receive 3 cycles vs 6 cycles of 3-weekly gemcitabine plus cisplatin/carboplatin, followed by 2-weekly maintenance avelumab until disease progression or intolerable toxicities. Avelumab treatment will be given up to a maximum of 2 years from the end of chemotherapy.
CONDITIONS
Official Title
Comparing 3 vs 6 Cycles of Platinum-based Chemotherapy Prior to Maintenance Avelumab in Advanced Urothelial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent.
- Able to comply with the study protocol including repeated quality of life questionnaires.
- Age 18 years or older.
- Histologically confirmed unresectable locally advanced or metastatic urothelial carcinoma (bladder, renal pelvis, ureter, or urethra), including some mixed cell types with urothelial component.
- Measurable disease according to RECIST v1.1.
- Eligible for gemcitabine plus cisplatin or gemcitabine plus carboplatin chemotherapy based on kidney function and other criteria.
- ECOG Performance Status of 0, 1, or 2.
- Adequate blood and organ function.
- Negative pregnancy test within 2 weeks before starting treatment for women of childbearing potential.
- Agreement to use effective contraception.
You will not qualify if you...
- Prior treatment with PD-(L)-1 inhibitors for advanced malignancy (except neoadjuvant or adjuvant use for urothelial cancer).
- Prior systemic therapy for advanced urothelial carcinoma except certain platinum regimens given more than 6 months ago.
- Pregnant or breastfeeding women.
- Active central nervous system metastases (treated CNS metastases allowed under conditions).
- Prior allogeneic stem cell or solid organ transplant.
- Live attenuated vaccine within 4 weeks before enrollment or planned during the study.
- Recent treatment with systemic immunostimulatory agents within 4 weeks.
- Participation in another therapeutic clinical trial within 4 weeks.
- Significant uncontrolled diseases affecting compliance or results.
- Other malignancies within 3 years except some low-risk treated cancers.
- Significant cardiovascular disease or recent serious cardiac events.
- Radiotherapy within 2 weeks before starting treatment.
- Major surgery within 4 weeks before randomization.
- History or evidence of active pneumonitis or certain lung diseases.
- Active hepatitis B or C infection; past resolved hepatitis B is allowed.
- Positive HIV test.
- Active tuberculosis.
- Active autoimmune diseases or certain autoimmune-related conditions.
- History of autoimmune hypothyroidism unless stable on replacement therapy.
- Severe allergic reactions to antibodies or study drugs.
- Known allergies to components of avelumab or chemotherapy drugs.
- Active infections needing systemic treatment.
- Persistent toxicities from prior therapies above specific grades.
- Any condition interfering with study treatment or safety.
- History of allergic reactions to cisplatin, gemcitabine, carboplatin, or related compounds.
- Presence of bleeding tumors.
- Other contraindications to study chemotherapy as per product information.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Unicancer
Paris, France
Actively Recruiting
2
Adknoma
Madrid, Spain
Enrolling by Invitation
3
Barts Health NHS Trust
London, United Kingdom
Actively Recruiting
Research Team
D
DISCUS Trial Coordinator
CONTACT
T
Thomas Powles
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here