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Urothelial CarcinomaPhase 2AVESECNCT07460245

Maintenance AVElumab After SECond Line Platinum-based Chemotherapy for Metastatic Urothelial Carcinoma

A Phase 2 study testing Avelumab 800 mg flat-dose IV in people with Urothelial Carcinoma, run by Gruppo Oncologico Italiano di Ricerca Clinica at 19 sites in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study represents an innovative opportunity in the treatment of metastatic urothelial carcinoma Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urothelial Carcinoma
What is being tested?
Avelumab 800 mg flat-dose IV
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
19 sitesItaly
Study dates
Jun 2026to Dec 2030
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

  • Histologically or cytologically-confirmed diagnosis of metastatic or locally advanced unresectable urothelial carcinoma of the bladder or upper tract with predominant transitional cell carcinoma.
  • Have received first-line of therapy consisting in enfortumab vedotin plus pembrolizumab and second-line of therapy with cisplatin or carboplatin plus gemcitabine (at least 3 cycles). Adjuvant or neoadjuvant chemotherapy is allowed if completed by >12 months.
  • Have not progressed per RECIST v1.1 guidelines (stable disease, partial response, complete response) following completion of 3-6 cycles of second-line chemotherapy.
  • Have measurable disease by RECIST v1.1 as assessed by the investigator.
  • Estimated life expectancy of at least 3 months.
  • Willing and able to comply to study visits and procedures and be available for the duration of the study.
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  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  • Adequate organ and bone marrow function, including:
  • Absolute neutrophil count (ANC) ≥1,500/mm3 or 1.5 x 109/L;
  • Platelets ≥100,000/mm3 or 100 x 109/L;
  • Hemoglobin ≥9 g/dL (may have been transfused);
  • Estimated creatinine clearance ≥30 mL/min calculated using the Cockcroft-Gault equation;
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN);
  • Total bilirubin ≤1.5 x ULN. For subjects with Gilbert's disease, ≤3 mg/dL.
  • Serum pregnancy test (for females of childbearing potential) negative at screening.
  • If in fertile age, must agree to use highly effective methods of contraception (licensed hormonal methods for female patients and condom for male patients) throughout the study and for at least 30 days after the last dose.
  • Male or femle ≥18 years.
  • Signed informed consent documenting that the patient has been informed on all the aspects of the study.
  • Stable medical condition, including the absence of acute exacerbations of chronic illnesses, serious infections, or major surgery within 4 weeks before registration, and otherwise noted in other inclusion/exclusion criteria.

Who cannot join

  • Patients whose disease progressed by RECIST v1.1 on second-line chemotherapy for urothelial cancer.
  • Prior grade ≥3 per National Cancer Institute-Common Terminology Criteria for Adverse Event (NCI-CTCAE) toxicity from an immune-checkpoint inhibitor (thyroid toxicity excluded).
  • Persisting toxicity related to prior therapy (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
  • Patients with known symptomatic central nervous system (SNC) metastases requiring steroids. Patients are eligible if treatment (radiation or surgery) for SNC metastases has been completed by at least 4 weeks before first study dose and have recovered from acute effects of treatment and are neurologically stable.
  • Has had major surgery within 4 weeks prior to first study dose. Complete wound healing must have occurred independently from the time passed.
  • Has received prior radiotherapy within 2 weeks prior to first study dose. Prior palliative radiotherapy to metastatic bone lesion(s) is permitted, provided it has been completed at least 48 hours prior to first study dose.
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  • Active autoimmune disease requiring high-dose steroids or immunosuppressive treatment. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
  • Diagnosis of any other malignancy within 5 years prior to randomization, except for radically treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix, or low-grade (Gleason 6) prostate cancer on surveillance.
  • Participation in other studies involving investigational drug(s) within 4 weeks prior to randomization with the exception of observational studies.
  • Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
  • Known prior severe hypersensitivity to study drug or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (CTCAE Grade ≥3).
  • Current or prior use of immunosuppressive medication within 7 days prior to randomization, EXCEPT the following:
  • intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection);
  • systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent;
  • steroids as premedication for hypersensitivity reactions (eg, CT scan premedication).
  • Active and/or uncontrolled infection. The following exceptions apply:
  • Participants with HIV infection are eligible if they are on effective antiretroviral therapy with undetectable viral load within 6 months, provided there is no expected drug-drug interaction.
  • Participants with evidence of chronic HBV infection are eligible if the HBV viral load is undetectable on suppressive therapy (if indicated), and if they have ALT, AST, and total bilirubin levels < ULN, and provided there is no expected drug-drug interaction.
  • Participants with a history of HCV infection are eligible if they have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load, and if they have ALT, AST, and total bilirubin levels < ULN.
  • Other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behaviour; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
  • Prior organ transplantation including allogenic stem-cell transplantation;
  • Vaccination within 4 weeks of the first dose of study treatment and while on trial is prohibited except for administration of inactivate vaccines (eg, inactivated influenza vaccines).
  • Pregnant or lactating female patients; male patients able to father children, and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception for the duration of the study and for at least 60 days after the last dose of study drug.

Trial locations and contacts

19 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Francesco Massari, MD contact

0512142206

Francesco.massari@aosp.bo.it

19 sites in 1 country

Italy19 sites

  • Oncologia Medica Universitaria, Azienda Ospedaliera Universitaria Consorziale Policlinico Di Bari

    Bari, BA

    Mimma Rizzo

  • UOC di Oncologia Medica AOU Policlinico S. Orsola Malpighi

    Bologna, BO, 40138

    Francesco Massari

  • AOU Careggi

    Florence, FI, 50134

    Lorenzo Antonuzzo

  • POLICLINICO RIUNITI FOGGIA Oncologia Medica

    Foggia, FG, 71122

    Vincenza Conteduca

  • UOC ONCOLOGIA MEDICA IRCCS Ospedale Policlinico San Martino

    Genova, GE, 16132

    Giuseppe Fornarini

  • Istituto Romagnolo Per Lo Studio Dei Tumori "Dino Amadori" Irccs Irst

    Meldola, FC, 47014

    Cristian Lolli

  • Irccs San Raffaele - Milano

    Milan, MI, 20132

    Brigida Anna Maiorano

  • Uoc Oncologia Medica Fondazione Irccs Istituto Nazionale Dei Tumori

    Milan, MI, 20133

    Patrizia Giannatempo

  • Uoc Oncologia Medica- Azienda Ospedaliero-Universitaria Di Modena

    Modena, MO, 41124

    Maria Giuseppa Vitale

  • Aou Federico Ii - Uoc Di Oncologia Medica

    Naples, 80131

    Luigi Formisano

  • Uoc Oncologia Medica Aorn Cardarelli Napoli

    Naples, 80131

    Sarah Scagliarini

  • UOC di Oncologia Medica 2 IOV Istituto Oncologico Veneto

    Padova, PD, 35128

    Marco Maruzzo

  • Uoc Oncologia Medica A.R.Na.S.Civico Benefratelli Di Cristina

    Palermo, PA, 90127

    Carlo Messina

  • Uoc Oncologia Medica Aou Parma

    Parma, PR, 43126

    Sebastiano Buti

  • Uoc Oncologia - Ospedale Di Macerata

    Province of Macerata, MC, 62100

    Matteo Santoni

  • Ausl/Irccs Di Reggio Emilia - S.O.C. Oncologia Medica Provinciale

    Reggio Emilia, RE, 42123

    Amelia Altavilla

  • Uoc Oncologia Medica Fondazione Policlinico Universitario A. Gemelli Irccs

    Roma, RM, 00168

    Roberto Iacovelli

  • AO Santa Maria della Misericordia di Perugia-Struttura Complessa di Oncologia Medica

    Terni, TR, 06132

    Claudia Caserta

  • UOC Oncologia Medica AOU di Verona

    Verona, VR, 37126

    Emanuela Fantinel

Other trials in Italy

About this study

Official title: Maintenance AVElumab After SECond Line Platinum-based Chemotherapy for Metastatic Urothelial Carcinoma:AVESEC Trial - AVESEC Study

This study represents an innovative opportunity in the treatment of metastatic urothelial carcinoma

Read the detailed description

Phase II, multicenter, randomized, open-label, efficacy and safety study of maintenance avelumab compared to BSC in advanced or metastatic urothelial carcinoma patients not progressed on second-line platinum-based chemotherapy (carboplatin or cisplatin plus gemcitabine) pretreated with pembrolizumab plus enfortumab vedotin.

Being tested
Avelumab 800 mg flat-dose IV
Keywords
Avelumab
Medical subject headings
Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Avelumab 800 mg flat-dose IVDrug

    Avelumab 800 mg flat-dose IV every 2 weeks

Study groups in NCT07460245
Study groupRoleWhat they receive
Arm AExperimentalAvelumab 800 mg flat-dose IV every 2 weeks plus BSC
Receives: Drug: Avelumab 800 mg flat-dose IV
Arm BNo interventionBSC alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Endopoint

    1-year PFS based on BICR assessment per RECIST v1.1

    Measured: At 12 months from randomization

Secondary outcomes (6)

  1. Secondary Endpoint

    Overall Survival (OS)

    Measured: Four Years

  2. Secondary Outcome

    Investigator-assessed PFS

    Measured: Four Years

  3. Secondary Outcome

    Objective response rates (ORR)

    Measured: Four years

  4. Secondary Outcome

    Duration of response (DR)

    Measured: Four Years

  5. Secondary Outcome

    Disease control rate (DCR) assessed per RECIST v1.1 by BICR and investigator

    Measured: Four Years

  6. Secondary Outcome

    Safety: Adverse events (AEs) and laboratory abnormalities as graded by Common Terminology Criteria for Adverse Events (CTCAE) v.5.0

    Measured: Four Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionJun 2026 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

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
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07460245
Sponsor's protocol ID
GOIRC-02-2025
Acronym
AVESEC
Status last verified
Feb 2026
First submitted
23 Feb 2026
Last updated
10 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Avelumab 800 mg flat-dose IV in people with Urothelial Carcinoma, run by Gruppo Oncologico Italiano di Ricerca Clinica at 19 sites in Italy.

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 19 inclusion and 23 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: opening soon, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Italy. 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 Francesco Massari, MD (0512142206, Francesco.massari@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Endopoint (time frame: At 12 months from randomization). 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 NCT07460245.

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 10 Mar 2026.

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