Brief Title: Pembrolizumab (MK-3475) Plus V940 in Participants With Bladder Cancer Post-Radical Resection (V940-005)

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Adjuvant Cohort: Disease Free Survival (DFS)

Primary Outcome 1 - Timeframe: Up to approximately 28 months

Primary Outcome 2 - Measure: Perioperative Cohort: Number of Participants Who Experience an Adverse Event (AE)

Primary Outcome 2 - Timeframe: Up to approximately 19 months

Primary Outcome 3 - Measure: Perioperative Cohort: Number of Participants Who Discontinue Study Treatment Due to AE

Primary Outcome 3 - Timeframe: Up to approximately 16 months

CONDITION

• Bladder Cancer

ELIGIBILITY

Inclusion Criteria:
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
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 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Medical Director

Role: Study Director

Affiliation: Merck Sharp & Dohme LLC

Overall Contact

Name: Toll Free Number

Phone: 1-888-577-8839

Email: [email protected]

LOCATION