Urinary Bladder NeoplasmsPhase 2DISCUSNCT06892860
Comparing 3 vs 6 Cycles of Platinum-based Chemotherapy Prior to Maintenance Avelumab in Advanced Urothelial Cancer
A Phase 2 study testing Avelumab in people with Urinary Bladder Neoplasms, run by Queen Mary University of London at 3 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Neoplasms
- What is being tested?
- Avelumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 16 Dec 2021to 22 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent.
- Ability to comply with the protocol, including but not limited to, the repeated completion of the EORTC QLQ-C30 questionnaires.
- Age ≥ 18 years.
- Histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Patients with squamous or sarcomatoid differentiation or mixed cell types are eligible but a component of urothelial cancer is required.
- Measurable disease by RECIST v1.1.
- Eligible for gemcitabine/ cisplatin or gemcitabine/carboplatin. The following criteria are established for the use of carboplatin (patients not fulfilling the following carboplatin criteria should be considered for gemcitabine/ cisplatin):
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- GFR <60 mL/min but ≥30 mL/min (measured by the Cockcroft-Gault formula or by local accepted standards). Subjects with a GFR ≥50 mL/min and no other cisplatin ineligibility criteria may be considered cisplatin-eligible based on the investigator's clinical judgement.
- ECOG or WHO performance status of 2.
- NCI CTCAE Grade ≥2 audiometric hearing loss.
- NYHA Class III heart failure.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2.
- Adequate haematologic and organ function as defined below:
- Negative serum or urine pregnancy test within 2 weeks of Day 1 Cycle 1 for female patients of childbearing potential only.
- Agreement to use adequate contraceptive measures
Who cannot join
- 1. Prior treatment with a PD-(L)-1 inhibitor for any advanced malignancy. Treatment with PD-(L)-1 inhibitors in the neoadjuvant or adjuvant setting for UC are permitted.
- 2. Prior systemic therapy for locally advanced or metastatic urothelial carcinoma with the following exceptions: a platinum containing regimen (cisplatin or carboplatin) in the neoadjuvant or adjuvant setting if more than 6 months since last cycle have occurred. Patients who received adjuvant or neoadjuvant immune therapy for muscle invasive or non-muscle invasive disease are eligible.
- 3. Pregnant and lactating female patients. 4. Known history of active CNS metastases. Patients with treated CNS metastases are permitted on the study if all of the following are true: 5. Prior allogeneic stem cell or solid organ transplantation. 6. Administration of a live, attenuated vaccine within 4 weeks prior to enrolment or anticipation that such a live, attenuated vaccine will be required during the study.
- 7. Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin [IL]-2) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrolment (see section 11.26).
- 8. Concurrent treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 4 weeks prior to enrolment.
- 9. Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome).
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- 10. Malignancies other than urothelial carcinoma within 3 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer (Gleason score ≤ 3 + 4 and PSA < 10 ng/mL undergoing active surveillance and treatment naive). .
- 11. Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction or cerebral vascular accident/stroke within 6 months prior to enrolment, unstable arrhythmias, or unstable angina.
- 12. Radiotherapy within 2 weeks prior to C1D1. Patients must have recovered adequately from toxicities resulting from the intervention prior to starting study treatment.
- 13. Major surgery (defined as requiring general anaesthesia and >24-hour inpatient hospitalization) within 4 weeks prior to randomisation. Patients must have recovered adequately from complications from the intervention prior to starting study treatment.
- 14. History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan (History of radiation pneumonitis in the radiation field (fibrosis) is permitted).
- 15. Active hepatitis infection (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible.
- 16. Positive HIV test. 17. Active tuberculosis. 18. Active autoimmune disease including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
- 19. History of autoimmune-related hypothyroidism, unless on a stable dose of thyroid replacement hormone.
- 20. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies.
- 21. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of avelumab.
- 22. Active infection requiring systemic therapy. 23. Persisting toxicity related to prior therapy (NCI CTCAE Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.
- 24. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results 25. Participants with previous or known history of allergic reaction to cisplatin, gemcitabine, carboplatin or other platinum containing compounds, or any component of the chemotherapy formulations.
- 26. Patients with bleeding tumours 27. Any other contraindication for gemcitabine/ cisplatin or gemcitabine/carboplatin treatment as per SmPC.
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Thomas Powles contact
3 sites in 3 countries
France1 site, 1 recruiting
- Recruiting
Unicancer
Paris
Yohann Loriot, +442078848497, bci-discus@qmul.ac.uk
United Kingdom1 site, 1 recruiting
- Recruiting
Barts Health NHS Trust
London
Thomas Powles
About this study
Official title: A Randomised Phase II Study Comparing 3 vs 6 Cycles of Platinum-based Chemotherapy Prior to Maintenance Avelumab in Advanced Urothelial Cancer
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
- Urinary Bladder Neoplasms
- Being tested
- Avelumab
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvelumabDrug
Avelumab treatment will be given up to a maximum of 2 years from the end of chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| 3 cycles of gemcitabine + cisplatin/carboplatin followed by avelumab | Experimental | Gemcitabine and cisplatin/carboplatin will be dispensed to patients on day 1 of each 21-day cycle of chemotherapy (3 cycles). Gemcitabine will additionally be dispensed to patients on day 8 of each 21-day cycle of chemotherapy. Following completion of gemcitabine and cisplatin/carboplatin chemotherapy, patients will then receive maintenance avelumab within 10 weeks of completing chemotherapy, on day 1 and 15 of each 28-day cycle for up to 2 years after the end of chemotherapy. Receives: Drug: Avelumab |
| 6 cycles of gemcitabine + cisplatin/carboplatin followed by avelumab | Active comparator | Gemcitabine and cisplatin/carboplatin will be dispensed to patients on day 1 of each 21-day cycle of chemotherapy (6 cycles). Gemcitabine will additionally be dispensed to patients on day 8 of each 21-day cycle of chemotherapy. Following completion of gemcitabine and cisplatin/carboplatin chemotherapy, patients will then receive maintenance avelumab within 10 weeks of completing chemotherapy, on day 1 and 15 of each 28-day cycle for up to 2 years after the end of chemotherapy. Receives: Drug: Avelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of 3 vs 6 cycles platinum-based, front-line chemotherapy followed by maintenance avelumab based on patient-reported outcomes (PROs) in the study population.
Change in GHS/QoL scale scores from baseline to completion of 6 cycles of treatment. Patients who withdraw from treatment between Cycles 4 and 6 will be included, provided an EORTC QLQ-C30 questionnaire is completed within 14 days from the date of withdrawal.
Measured: Cycle 6 (Arm A: 3x cycles of chemotherapy (21 days per cycle) plus 3x cycles of Avelumab (28 days per cycle), Arm B: 6 cycles of chemotherapy only (21 days per cycle)
Secondary outcomes (4)
To evaluate the effect of 3 vs 6 cycles platinum-based, front-line chemotherapy followed by maintenance avelumab based on additional patient-reported outcomes (PROs) in the study population.
Quality of Life Assessment using the GHS/QOL scale score
Measured: 10 cycles of treatment (Arm A: 3x cycles of chemotherapy (21 days per cycle) plus 7x cycles of Avelumab (28 days per cycle), Arm B: 6 cycles of chemotherapy (21 days per cycle) followed by 4x cycles of avelumab (28 days per cycle))
To evaluate the effect of 3 vs 6 cycles platinum-based, front-line chemotherapy followed by maintenance avelumab based on clinician reported outcomes.
Performance Status as measured by the Karnofsky Scale on completion of 6 cycles of treatment.
Measured: On completion of 6 cycles of treatment (From baseline to completion of cycle 6 (Arm A: 3x cycles of chemotherapy (21 days per cycle) plus 3x cycles of Avelumab (28 days per cycle), Arm B: 6 cycles of chemotherapy only (21 days per cycle)))
To evaluate the safety and tolerability of 3 vs 6 cycles of platinum-based, front-line chemotherapy followed by maintenance avelumab therapy.
Adverse events graded according to NCI-CTCAE v5.0
Measured: From baseline throughout treatment (From baseline to completion of cycle 6 (Arm A: 3x cycles of chemotherapy followed by Avelumab, Arm B: 6 cycles of chemotherapy followed by Avelumab) for a maximum of 2 years on avelumab.
To assess the efficacy of 3 vs 6 cycles platinum based, front-line chemotherapy followed by maintenance avelumab in patients with advanced UC.
Efficacy endpoints
Measured: Baseline until end of trial participation (maximum of 2 years on avelumab)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start16 Dec 2021
- Primary completion30 Jun 2027 (estimated)
- Study completion22 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892860
- Sponsor's protocol ID
- DISCUS
- Acronym
- DISCUS
- Status last verified
- May 2026
- First submitted
- 29 Jul 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Powles T, Hussain SA, Climent MA, Carbonero IG, Molina-Cerrillo J, Puente J, Borrega P, Malik J, Dourthe LM, Jones R, Castellano D, Duran I, Loriot Y, Priyadarshini G, Szabados B, Jamal F, Wang YQ, Kotriwala N, Jackson-Spence F, Ackerman C, Grande E. 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. Ann Oncol. 2026 Feb;37(2):250-259. doi: 10.1016/j.annonc.2025.10.011. Epub 2025 Oct 17.
PubMed 41110700
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Phase II Study Comparing 3 vs 6 Cycles of Platinum-based Chemotherapy Prior to Maintenance Avelumab in Advanced Urothelial Cancer
- ClinicalTrials.gov ID
- NCT06892860
- Acronym / sponsor ID
- DISCUS / DISCUS
- Conditions
- Urinary Bladder Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 22 Dec 2027 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 cycles of gemcitabine + cisplatin/carboplatin followed by avelumab | Experimental | Drug: AvelumabGemcitabine and cisplatin/carboplatin will be dispensed to patients on day 1 of each 21-day cycle of chemotherapy (3 cycles). Gemcitabine will additionally be dispensed to patients on day 8 of each 21-day cycle of chemotherapy. Following completion of gemcitabine and cisplatin/carboplatin chemotherapy, patients will then receive maintenance avelumab within 10 weeks of completing chemotherapy, on day 1 and 15 of each 28-day cycle for up to 2 years after the end of chemotherapy. |
| 6 cycles of gemcitabine + cisplatin/carboplatin followed by avelumab | Active comparator | Drug: AvelumabGemcitabine and cisplatin/carboplatin will be dispensed to patients on day 1 of each 21-day cycle of chemotherapy (6 cycles). Gemcitabine will additionally be dispensed to patients on day 8 of each 21-day cycle of chemotherapy. Following completion of gemcitabine and cisplatin/carboplatin chemotherapy, patients will then receive maintenance avelumab within 10 weeks of completing chemotherapy, on day 1 and 15 of each 28-day cycle for up to 2 years after the end of chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Willing and able to provide written informed consent.
- Ability to comply with the protocol, including but not limited to, the repeated completion of the EORTC QLQ-C30 questionnaires.
- Age ≥ 18 years.
- Histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Patients with squamous or sarcomatoid differentiation or mixed cell types are eligible but a component of urothelial cancer is required.
- Measurable disease by RECIST v1.1.
Key exclusion criteria (19 listed)
- 1. Prior treatment with a PD-(L)-1 inhibitor for any advanced malignancy. Treatment with PD-(L)-1 inhibitors in the neoadjuvant or adjuvant setting for UC are permitted.
- 2. Prior systemic therapy for locally advanced or metastatic urothelial carcinoma with the following exceptions: a platinum containing regimen (cisplatin or carboplatin) in the neoadjuvant or adjuvant setting if more than 6 months since last cycle have occurred. Patients who received adjuvant or neoadjuvant immune therapy for muscle invasive or non-muscle invasive disease are eligible.
- 3. Pregnant and lactating female patients. 4. Known history of active CNS metastases. Patients with treated CNS metastases are permitted on the study if all of the following are true: 5. Prior allogeneic stem cell or solid organ transplantation. 6. Administration of a live, attenuated vaccine within 4 weeks prior to enrolment or anticipation that such a live, attenuated vaccine will be required during the study.
- 7. Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin [IL]-2) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrolment (see section 11.26).
- 8. Concurrent treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 4 weeks prior to enrolment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvelumabAvelumab treatment will be given up to a maximum of 2 years from the end of chemotherapy | Drug | 3 cycles of gemcitabine + cisplatin/carboplatin followed by avelumab, 6 cycles of gemcitabine + cisplatin/carboplatin followed by avelumab |
Primary outcome
To evaluate the effect of 3 vs 6 cycles platinum-based, front-line chemotherapy followed by maintenance avelumab based on patient-reported outcomes (PROs) in the study population.
Time frame: Cycle 6 (Arm A: 3x cycles of chemotherapy (21 days per cycle) plus 3x cycles of Avelumab (28 days per cycle), Arm B: 6 cycles of chemotherapy only (21 days per cycle)
Change in GHS/QoL scale scores from baseline to completion of 6 cycles of treatment. Patients who withdraw from treatment between Cycles 4 and 6 will be included, provided an EORTC QLQ-C30 questionnaire is completed within 14 days from the date of withdrawal.
4 secondary outcomes
To evaluate the effect of 3 vs 6 cycles platinum-based, front-line chemotherapy followed by maintenance avelumab based on additional patient-reported outcomes (PROs) in the study population.
Time frame: 10 cycles of treatment (Arm A: 3x cycles of chemotherapy (21 days per cycle) plus 7x cycles of Avelumab (28 days per cycle), Arm B: 6 cycles of chemotherapy (21 days per cycle) followed by 4x cycles of avelumab (28 days per cycle))
To evaluate the effect of 3 vs 6 cycles platinum-based, front-line chemotherapy followed by maintenance avelumab based on clinician reported outcomes.
Time frame: On completion of 6 cycles of treatment (From baseline to completion of cycle 6 (Arm A: 3x cycles of chemotherapy (21 days per cycle) plus 3x cycles of Avelumab (28 days per cycle), Arm B: 6 cycles of chemotherapy only (21 days per cycle)))
To evaluate the safety and tolerability of 3 vs 6 cycles of platinum-based, front-line chemotherapy followed by maintenance avelumab therapy.
Time frame: From baseline throughout treatment (From baseline to completion of cycle 6 (Arm A: 3x cycles of chemotherapy followed by Avelumab, Arm B: 6 cycles of chemotherapy followed by Avelumab) for a maximum of 2 years on avelumab.
To assess the efficacy of 3 vs 6 cycles platinum based, front-line chemotherapy followed by maintenance avelumab in patients with advanced UC.
Time frame: Baseline until end of trial participation (maximum of 2 years on avelumab)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 41110700Powles T, Hussain SA, Climent MA, Carbonero IG, Molina-Cerrillo J, Puente J, Borrega P, Malik J, Dourthe LM, Jones R, Castellano D, Duran I, Loriot Y, Priyadarshini G, Szabados B, Jamal F, Wang YQ, Kotriwala N, Jackson-Spence F, Ackerman C, Grande E. 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. Ann Oncol. 2026 Feb;37(2):250-259. doi: 10.1016/j.annonc.2025.10.011. Epub 2025 Oct 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Powles contact
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avelumab in people with Urinary Bladder Neoplasms, run by Queen Mary University of London at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DISCUS Trial Coordinator (bci-discus@qmul.ac.uk, Bci-discus@qmul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effect of 3 vs 6 cycles platinum-based, front-line chemotherapy followed by maintenance avelumab based on patient-reported outcomes (PROs) in the study population. (time frame: Cycle 6 (Arm A: 3x cycles of chemotherapy (21 days per cycle) plus 3x cycles of Avelumab (28 days per cycle), Arm B: 6 cycles of chemotherapy only (21 days per cycle)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06892860, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.