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

March 3, 2026 updated by: Gruppo Oncologico Italiano di Ricerca Clinica

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Napoli, Italy, 80131
        • Aou Federico Ii - Uoc Di Oncologia Medica
        • Contact:
          • Luigi Formisano
      • Napoli, Italy, 80131
        • Uoc Oncologia Medica Aorn Cardarelli Napoli
        • Contact:
          • Sarah Scagliarini
    • BA
      • Bari, BA, Italy
        • Oncologia Medica Universitaria, Azienda Ospedaliera Universitaria Consorziale Policlinico Di Bari
        • Contact:
          • Mimma Rizzo
    • BO
      • Bologna, BO, Italy, 40138
        • UOC di Oncologia Medica AOU Policlinico S. Orsola Malpighi
        • Contact:
          • Francesco Massari
    • FC
      • Meldola, FC, Italy, 47014
        • Istituto Romagnolo Per Lo Studio Dei Tumori "Dino Amadori" Irccs Irst
        • Contact:
          • Cristian Lolli
    • FG
      • Foggia, FG, Italy, 71122
        • POLICLINICO RIUNITI FOGGIA Oncologia Medica
        • Contact:
          • Vincenza Conteduca
    • FI
      • Florence, FI, Italy, 50134
        • Aou Careggi
        • Contact:
          • Lorenzo Antonuzzo
    • GE
      • Genova, GE, Italy, 16132
        • UOC ONCOLOGIA MEDICA IRCCS Ospedale Policlinico San Martino
        • Contact:
          • Giuseppe Fornarini
    • MC
      • Macerata, MC, Italy, 62100
        • Uoc Oncologia - Ospedale Di Macerata
        • Contact:
          • Matteo Santoni
    • MI
      • Milan, MI, Italy, 20132
        • Irccs San Raffaele - Milano
        • Contact:
          • Brigida Anna Maiorano
      • Milan, MI, Italy, 20133
        • Uoc Oncologia Medica Fondazione Irccs Istituto Nazionale Dei Tumori
        • Contact:
          • Patrizia Giannatempo
    • MO
      • Modena, MO, Italy, 41124
        • Uoc Oncologia Medica- Azienda Ospedaliero-Universitaria Di Modena
        • Contact:
          • Maria Giuseppa Vitale
    • PA
      • Palermo, PA, Italy, 90127
        • Uoc Oncologia Medica A.R.Na.S.Civico Benefratelli Di Cristina
        • Contact:
          • Carlo Messina
    • PD
      • Padua, PD, Italy, 35128
        • UOC di Oncologia Medica 2 IOV Istituto Oncologico Veneto
        • Contact:
          • Marco Maruzzo
    • PR
      • Parma, PR, Italy, 43126
        • Uoc Oncologia Medica Aou Parma
        • Contact:
          • Sebastiano Buti
    • RE
      • Reggio Emilia, RE, Italy, 42123
        • Ausl/Irccs Di Reggio Emilia - S.O.C. Oncologia Medica Provinciale
        • Contact:
          • Amelia Altavilla
    • RM
      • Roma, RM, Italy, 00168
        • Uoc Oncologia Medica Fondazione Policlinico Universitario A. Gemelli Irccs
        • Contact:
          • Roberto Iacovelli
    • TR
      • Terni, TR, Italy, 06132
        • AO Santa Maria della Misericordia di Perugia-Struttura Complessa di Oncologia Medica
        • Contact:
          • Claudia Caserta
    • VR
      • Verona, VR, Italy, 37126
        • UOC Oncologia Medica AOU di Verona
        • Contact:
          • Emanuela Fantinel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

  • Adequate organ and bone marrow function, including:

    1. Absolute neutrophil count (ANC) ≥1,500/mm3 or 1.5 x 109/L;
    2. Platelets ≥100,000/mm3 or 100 x 109/L;
    3. Hemoglobin ≥9 g/dL (may have been transfused);
    4. Estimated creatinine clearance ≥30 mL/min calculated using the Cockcroft-Gault equation;
    5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN);
    6. 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.

Exclusion Criteria:

  • 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.
  • 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:

    1. intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection);
    2. systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent;
    3. steroids as premedication for hypersensitivity reactions (eg, CT scan premedication).

  • Active and/or uncontrolled infection. The following exceptions apply:

    1. 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.
    2. 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.
    3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A
Avelumab 800 mg flat-dose IV every 2 weeks plus BSC
Drug: Avelumab 800 mg flat-dose IV
Avelumab 800 mg flat-dose IV every 2 weeks
No Intervention: Arm B
BSC alone

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Endopoint
Time Frame: At 12 months from randomization
1-year PFS based on BICR assessment per RECIST v1.1
At 12 months from randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary Endpoint
Time Frame: Four Years
Overall Survival (OS)
Four Years
Secondary Outcome
Time Frame: Four Years
Investigator-assessed PFS
Four Years
Secondary Outcome
Time Frame: Four years
Objective response rates (ORR)
Four years
Secondary Outcome
Time Frame: Four Years
Duration of response (DR)
Four Years
Secondary Outcome
Time Frame: Four Years
Disease control rate (DCR) assessed per RECIST v1.1 by BICR and investigator
Four Years
Secondary Outcome
Time Frame: Four Years
Safety: Adverse events (AEs) and laboratory abnormalities as graded by Common Terminology Criteria for Adverse Events (CTCAE) v.5.0
Four Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gruppo Oncologico Italiano di Ricerca Clinica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GOIRC-02-2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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