Urothelial Carcinoma
Conditions
Keywords
Avelumab
Brief summary
This study represents an innovative opportunity in the treatment of metastatic urothelial carcinoma
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.
Interventions
DRUGAvelumab 800 mg flat-dose IV
Avelumab 800 mg flat-dose IV every 2 weeks
Sponsors
Gruppo Oncologico Italiano di Ricerca Clinica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endopoint | At 12 months from randomization | 1-year PFS based on BICR assessment per RECIST v1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoint | Four Years | Overall Survival (OS) |
| Secondary Outcome | Four Years | Investigator-assessed PFS |
Countries
Italy
Contacts
CONTACTFrancesco Massari, MD
Outcome results
None listed