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A clinical study of V940 treatment and pembrolizumab in people with bladder cancer (V940-005)
EU CTIS ID: 2023-505658-17-00
What this study is testing
1. Adjuvant Cohort: To compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to DFS. 2. Perioperative Cohort: To evaluate the safety and tolerability of V940 plus pembrolizumab plus EV
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Has a histological diagnosis of UC
- Perioperative Cohort: Is ineligible to receive cisplatin according to protocol pre-defined criteria
- Must provide blood samples per protocol, to enable V940 production, and circulating tumor Deoxyribonucleic acid (ctDNA) testing
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization
- Must provide a formalin-fixed paraffin-embedded (FFPE) tumor tissue sample for next generation sequencing (NGS)
- Adjuvant Cohort: Has muscle-invasive urothelial carcinoma (MIUC)
You likely can't join if
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Perioperative Cohort: Has severe hypersensitivity to either V940, pembrolizumab, or enfortumab vedotin (EV) and/or any of their excipients
- Perioperative Cohort: Has ongoing sensory or motor neuropathy
- Perioperative Cohort: Has active keratitis or corneal ulcerations
- Has known additional malignancy that is progressing or has required active treatment ≤3 years prior to study randomization
- Has current pneumonitis/interstitial lung disease
See the full eligibility criteria
- Has a histological diagnosis of UC
- Perioperative Cohort: Is ineligible to receive cisplatin according to protocol pre-defined criteria
- Must provide blood samples per protocol, to enable V940 production, and circulating tumor Deoxyribonucleic acid (ctDNA) testing
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization
- Must provide a formalin-fixed paraffin-embedded (FFPE) tumor tissue sample for next generation sequencing (NGS)
- Adjuvant Cohort: Has muscle-invasive urothelial carcinoma (MIUC)
- Adjuvant Cohort: Has high-risk pathologic disease after radical resection
- Adjuvant Cohort: For participants who have not received cisplatin-based neoadjuvant chemotherapy, are ineligible to receive cisplatin according to protocol pre-defined criteria
- Perioperative Cohort: Has muscle-invasive bladder cancer (MIBC)
- Perioperative Cohort: Is deemed eligible for radical cystectomy (RC) and pelvic lymph node dissection (PLND) and agrees to undergo curative intent standard RC and PLND and neoadjuvant and adjuvant treatment per protocol
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Perioperative Cohort: Has severe hypersensitivity to either V940, pembrolizumab, or enfortumab vedotin (EV) and/or any of their excipients
- Perioperative Cohort: Has ongoing sensory or motor neuropathy
- Perioperative Cohort: Has active keratitis or corneal ulcerations
- 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
- Adjuvant Cohort: Has received prior neoadjuvant therapy, with the exception of neoadjuvant cisplatin-based chemotherapy for MIUC
- Adjuvant Cohort: 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
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- Colombia
- United Kingdom
- Canada
- Peru
- New Zealand
- United States
- Australia
- Korea, Republic of
- Chile
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey; Colombia; United Kingdom; Canada; Peru; New Zealand and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.