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

NCT07460245 | Not Yet Recruiting Phase 2

• 1 other identifier: GOIRC-02-2025
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 19

Brief Summary

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

Conditions

Urothelial Carcinoma

Keywords

Avelumab

Outcome Measures

Primary Outcomes (1)

• Primary Endopoint

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

  At 12 months from randomization

Secondary Outcomes (6)

• Secondary Endpoint

  Four Years

• Secondary Outcome

  Four Years

• Secondary Outcome

  Four years

• Secondary Outcome

  Four Years

• Secondary Outcome

  Four Years

Study Arms (2)

Arm A

EXPERIMENTAL

Avelumab 800 mg flat-dose IV every 2 weeks plus BSC

Drug: Avelumab 800 mg flat-dose IV

Arm B

NO INTERVENTION

BSC alone

Interventions

Avelumab 800 mg flat-dose IV DRUG

Avelumab 800 mg flat-dose IV every 2 weeks

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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:
• 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).

Sponsors & Collaborators

• Gruppo Oncologico Italiano di Ricerca Clinica: lead

Study Sites (19)

Oncologia Medica Universitaria, Azienda Ospedaliera Universitaria Consorziale Policlinico Di Bari

Bari, BA, Italy

Location

UOC di Oncologia Medica AOU Policlinico S. Orsola Malpighi

Bologna, BO, 40138, Italy

Location

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

Meldola, FC, 47014, Italy

Location

POLICLINICO RIUNITI FOGGIA Oncologia Medica

Foggia, FG, 71122, Italy

Location

AOU Careggi

Florence, FI, 50134, Italy

Location

UOC ONCOLOGIA MEDICA IRCCS Ospedale Policlinico San Martino

Genova, GE, 16132, Italy

Location

Uoc Oncologia - Ospedale Di Macerata

Macerata, MC, 62100, Italy

Location

Irccs San Raffaele - Milano

Milan, MI, 20132, Italy

Location

Uoc Oncologia Medica Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, MI, 20133, Italy

Location

Uoc Oncologia Medica- Azienda Ospedaliero-Universitaria Di Modena

Modena, MO, 41124, Italy

Location

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

Palermo, PA, 90127, Italy

Location

UOC di Oncologia Medica 2 IOV Istituto Oncologico Veneto

Padua, PD, 35128, Italy

Location

Uoc Oncologia Medica Aou Parma

Parma, PR, 43126, Italy

Location

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

Reggio Emilia, RE, 42123, Italy

Location

Uoc Oncologia Medica Fondazione Policlinico Universitario A. Gemelli Irccs

Roma, RM, 00168, Italy

Location

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

Terni, TR, 06132, Italy

Location

UOC Oncologia Medica AOU di Verona

Verona, VR, 37126, Italy

Location

Aou Federico Ii - Uoc Di Oncologia Medica

Naples, 80131, Italy

Location

Uoc Oncologia Medica Aorn Cardarelli Napoli

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

avelumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Francesco Massari, MD

CONTACT

0512142206; Francesco.massari@aosp.bo.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 10, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 10, 2026

Record last verified: 2026-02

Locations

IT (19)