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

Launched by MERCK SHARP & DOHME LLC · Mar 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people with high-risk muscle-invasive urothelial carcinoma (MIUC), a serious type of bladder cancer. The researchers want to find out if a combination of a new treatment called V940 and an immunotherapy drug called pembrolizumab can help prevent the cancer from coming back after surgery. V940 works by training the immune system to recognize and attack cancer cells, while pembrolizumab helps boost the immune response against the cancer. The trial aims to see if this combination can keep patients alive and cancer-free for a longer time compared to those receiving a placebo (a non-active treatment) with pembrolizumab.

To be eligible for this study, participants must have MIUC and meet certain health criteria, such as providing blood samples and tumor tissue for testing. They should also be in good overall health, with specific limitations on previous cancer treatments. Participants can expect to receive regular monitoring and support throughout the trial to ensure their safety. This study is currently recruiting participants of all genders, aged 65 to 74, and it’s important to note that those with certain medical conditions or recent cancer treatments may not qualify.

Gender

ALL

Eligibility criteria

• 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 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
• 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 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
• • Has ongoing sensory or motor neuropathy
• • Has active keratitis or corneal ulcerations