Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
With
ModernaTX, Inc.
Enrollment of participants into the Phase 1 Perioperative Cohort of this study is planned to start in approximately April of 2025.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Has a histological diagnosis of urothelial carcinoma (UC)
Must provide blood samples per protocol, to enable intismeran autogene 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 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
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
You may not be if
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 intismeran autogene 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 intismeran autogene, pembrolizumab, or EV and/or any of their excipients
