V940-005 - A Clinical Study of V940 Treatment and Pembrolizumab in People With Bladder Cancer (INTerpath-005)

Studio Clinico

Patologia: Carcinoma della vescica

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: 1, II

Richiesta mandatoria di tessuto: Sì

Linee di trattamento: Adiuvante/neoadiuvante

Criteri di inclusione: 

The main inclusion criteria include but are not limited to the following:

- Must provide blood samples per protocol, to enable V940 production, and circulating tumor deoxyribonucleic acid testing
- Has an Eastern Cooperative Oncology Group performance status of 0 to 2 assessed within 7 days before randomization
- Must provide a formalin-fixed paraffin-embedded tumor tissue sample for next generation sequencing

Adjuvant Cohort:

- Has MIUC
- Has dominant histology of urothelial carcinoma (UC)
- Has high-risk pathologic disease after radical resection
- For participants who have not received cisplatin-based neoadjuvant chemotherapy, are ineligible to receive cisplatin according to protocol pre-defined criteria

Perioperative Cohort:

- Has MIBC
- Has a histological diagnosis of UC
- Is deemed eligible for RC and PLND and agrees to undergo curative intent standard RC and PLND and neoadjuvant and adjuvant treatment per protocol
- Is ineligible to receive cisplatin according to protocol pre-defined criteria.

Criteri di esclusione: 

The main exclusion criteria include but are not limited to the following:

- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Has known additional malignancy that is progressing or has required active treatment ≤3 years prior to study randomization
- Has current pneumonitis/interstitial lung disease
- Has active infection requiring systemic therapy
- Has active hepatitis B and hepatitis C virus infection

Adjuvant Cohort:

- Has received prior systemic anticancer therapy
- Has received prior neoadjuvant therapy, with the exception of neoadjuvant cisplatin-based chemotherapy for MIUC
- Has severe hypersensitivity to either V940 or pembrolizumab (MK-3475) and/or any of their excipients

Perioperative Cohort:

- Has received any prior systemic treatment, cancer vaccine treatment, chemoradiation, and/or radiation therapy treatment for MIBC
- Has severe hypersensitivity to either V940, pembrolizumab, or EV and/or any of their excipients
- Has ongoing sensory or motor neuropathy
- Has active keratitis or corneal ulcerations.

Trattamento sperimentale: 

Adjuvant Cohort: Pembrolizumab + V940
Perioperative Cohort: Pembrolizumab + V940 + EV and Surgery

Trattamento di controllo: 

Adjuvant Cohort: Pembrolizumab + Placebo

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2023-505658-17

Data di inserimento: 24.06.2024

Data di aggiornamento: 23.12.2024

Promotore

Merck Sharp & Dohme LLC

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na