Three versus six cycles of platinum-based chemotherapy followed by avelumab maintenance as first-line treatment for advanced urothelial cancer: the phase II DISCUS trial.
T Powles, S A Hussain, M A Climent...
https://pubmed.ncbi.nlm.nih.gov/41110700Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID06892860
A Randomised Phase II Study 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
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates the impact on quality of life of giving 3 versus 6 cycles of first-line platinum-based chemotherapy followed by maintenance treatment with avelumab in patients with locally advanced or metastatic urothelial cancer. It is an adaptive, open-label, randomized phase II study involving patients with bladder or related urothelial cancers. The study aims to understand how the number of chemotherapy cycles before immunotherapy affects patient-reported outcomes and clinical measures. Participants will be randomly assigned to receive either 3 or 6 cycles of chemotherapy consisting of gemcitabine plus cisplatin or carboplatin given every 3 weeks. Gemcitabine is administered on day 1 and day 8 of each 21-day cycle. After chemotherapy, patients will start maintenance treatment with avelumab every 2 weeks, continuing for up to 2 years or until disease progression or intolerable side effects occur. The study compares these two chemotherapy durations followed by the same maintenance immunotherapy. Throughout the study, participants will complete patient-reported outcome questionnaires to assess quality of life and undergo clinical evaluations to monitor safety, tolerability, and disease response. The main outcome is the effect on quality of life after the treatment cycles, with secondary measures including additional patient and clinician-reported outcomes, safety, and treatment efficacy. The total duration on avelumab maintenance can last up to 2 years following chemotherapy. The study began in December 2021 and will continue until December 2027.
CONDITIONS
Brief Title
Comparing 3 vs 6 Cycles of Platinum-based Chemotherapy Prior to Maintenance Avelumab in Advanced Urothelial Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent.
- Ability to comply with the protocol, including repeated completion of quality of life questionnaires.
- Age 18 years or older.
- Histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma.
- Measurable disease by RECIST v1.1 criteria.
- Eligible for gemcitabine/cisplatin or gemcitabine/carboplatin chemotherapy based on kidney function and other clinical criteria.
- ECOG Performance Status score of 0, 1, or 2.
- Adequate blood and organ function.
- Negative pregnancy test within 2 weeks before treatment start for women of childbearing potential.
- Agreement to use adequate contraception methods.
You will not qualify if you...
- Prior treatment with PD-(L)-1 inhibitors for advanced cancer, except neoadjuvant or adjuvant use.
- Prior systemic therapy for advanced urothelial carcinoma except platinum regimens completed over 6 months ago.
- Pregnant or breastfeeding women.
- Active untreated central nervous system metastases.
- Previous allogeneic stem cell or solid organ transplant.
- Recent live attenuated vaccine within 4 weeks before enrollment.
- Recent treatment with immunostimulatory agents within 4 weeks.
- Concurrent participation in other therapeutic clinical trials within 4 weeks.
- Significant uncontrolled medical conditions affecting study compliance.
- Other cancers within 3 years except certain low-risk or treated cancers.
- Significant cardiovascular disease or events within 6 months.
- Recent radiotherapy or major surgery within specified recovery periods.
- History or active pneumonitis or pulmonary fibrosis.
- Active hepatitis B or C infection, or positive HIV test.
- Active tuberculosis.
- Active autoimmune diseases or certain autoimmune-related hypothyroidism.
- Severe allergic reactions to antibodies or avelumab components.
- Active infections requiring systemic treatment.
- Ongoing toxicity from prior therapies exceeding specified grades.
- Previous allergic reactions to platinum-based chemotherapy.
- Presence of bleeding tumors.
- Contraindications to gemcitabine/cisplatin or carboplatin as per medical guidelines.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to approximately 6 months depending on number of chemotherapy cycles plus up to 2 years of maintenance avelumab
Participants receive 3 or 6 cycles of platinum-based chemotherapy followed by maintenance treatment with avelumab.
Chemotherapy visits every 21 days for 3 or 6 cycles; maintenance avelumab visits twice monthly on day 1 and 15 of each 28-day cycle for up to 2 years
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
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Research Team
D
DISCUS Trial Coordinator
T
Thomas Powles
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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