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

Inclusion Criteria:

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

• 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 assessedwithin 7 days before randomization

• Must provide a formalin-fixed paraffin-embedded tumor tissue sample for nextgeneration sequencing

Adjuvant Cohort:

• Has MIUC

• Has high-risk pathologic disease after radical resection

• For participants who have not received cisplatin-based neoadjuvant chemotherapy, areineligible 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 RCand PLND and neoadjuvant and adjuvant treatment per protocol

• Is ineligible to receive cisplatin according to protocol pre-defined criteria

Exclusion Criteria:

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 doseof 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 neoadjuvantcisplatin-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 EVand/or any of their excipients

• Has ongoing sensory or motor neuropathy

• Has active keratitis or corneal ulcerations