A Study of Pembrolizumab (MK-3475) Plus V940 in Participants With Bladder Cancer Post-Radical Resection (V940-005)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06305767 |
Recruitment Status :
Recruiting
First Posted : March 12, 2024
Last Update Posted : May 10, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bladder Cancer | Biological: Pembrolizumab Biological: V940 Other: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, Randomized, Double-blind, Placebo- and Active-comparator Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With High-risk Muscle-invasive Urothelial Carcinoma Post-radical Resection |
Actual Study Start Date : | March 28, 2024 |
Estimated Primary Completion Date : | October 8, 2026 |
Estimated Study Completion Date : | April 8, 2031 |
Arm | Intervention/treatment |
---|---|
Experimental: Pembrolizumab + V940
Participants receive 400 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of every 6-week cycle for up to 9 cycles, plus 1 mg of V940 via intramuscular (IM) injection once available every 3 weeks up to a total of 9 doses. V940 doses may begin as soon as Day 22 of Cycle 1. The total duration of treatment is up to approximately 13 months.
|
Biological: Pembrolizumab
Administered via IV infusion at a dose of 400 mg on Day 1 of every 6-week cycle (Q6W) for up to 9 cycles.
Other Names:
Biological: V940 Administered via IM injection at a dose of 1 mg every 3 weeks (Q3W) for up to 9 doses. |
Active Comparator: Pembrolizumab + Placebo
Participants receive pembrolizumab 400 mg via IV infusion on Day 1 of each 6-week cycle for up to 9 cycles. Placebo will be administered every 3 weeks up to a total of 9 doses. The total duration of treatment is up to approximately 13 months.
|
Biological: Pembrolizumab
Administered via IV infusion at a dose of 400 mg on Day 1 of every 6-week cycle (Q6W) for up to 9 cycles.
Other Names:
Other: Placebo V940 diluent only (saline and/or dextrose) administered via IM injection Q3W for up to 9 doses. |
- Disease Free Survival (DFS) [ Time Frame: Up to approximately 28 months ]DFS is defined as the time from randomization until death from any cause, or presence of disease per investigator assessment with muscle-invasive (≥pT2) disease in the urothelial tract (upper tract or lower tract) or high grade T1 disease in the upper tract on imaging and biopsy, and/or disease recurrence outside the urothelial tract on imaging with or without confirmation by biopsy. DFS will be reported for each arm.
- Overall Survival (OS) [ Time Frame: Up to approximately 28 months ]Overall survival is defined as the time from randomization to death due to any cause. OS will be reported for each arm.
- Distant Metastasis-Free Survival (DMFS) [ Time Frame: Up to approximately 28 months ]DMFS is defined as the time from randomization until death from any cause, or disease recurrence outside the urothelial tract on imaging with or without confirmation by biopsy, per investigator assessment. DMFS will be reported for each arm.
- Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 16 months ]An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience AEs will be reported for each arm.
- Number of Participants Who Discontinue Study Treatment Due to an AE [ Time Frame: Up to approximately 13 months ]An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an adverse event will be presented. The number of participants who discontinue study treatment due to an AE will be reported for each arm.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Has muscle-invasive urothelial carcinoma (MIUC)
- Has dominant histology of UC
- Has high-risk pathologic disease after radical resection
- Must provide formalin-fixed paraffin-embedded (FFPE) tumor tissue sample for next generation sequencing (NGS)
- 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
Exclusion Criteria:
- Has received prior systemic anticancer therapy
- 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 severe hypersensitivity to either V940 or pembrolizumab and/or any of their excipients
- Has current pneumonitis/interstitial lung disease
- Has active infection requiring systemic therapy
- Has active hepatitis B and hepatitis C virus infection
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06305767
Contact: Toll Free Number | 1-888-577-8839 | Trialsites@merck.com |
United States, Florida | |
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0102) | Recruiting |
Orlando, Florida, United States, 32804 | |
Contact: Study Coordinator 205-520-6512 | |
Australia, New South Wales | |
Macquarie University-MQ Health Clinical Trials Unit ( Site 1803) | Recruiting |
Macquarie University, New South Wales, Australia, 2109 | |
Contact: Study Coordinator 0402856430 | |
Australia, Western Australia | |
One Clinical Research ( Site 1807) | Recruiting |
Nedlands, Western Australia, Australia, 6009 | |
Contact: Study Coordinator +61862799466 | |
Canada, Quebec | |
Centre Hospitalier de l'Université de Montréal ( Site 0005) | Recruiting |
Montréal, Quebec, Canada, H2X 3E4 | |
Contact: Study Coordinator 5148908000 | |
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0 | Recruiting |
Quebec City, Quebec, Canada, G1J 1Z4 | |
Contact: Study Coordinator 4185254444 | |
Chile | |
ONCOCENTRO APYS-ACEREY ( Site 1506) | Recruiting |
Viña del Mar, Valparaiso, Chile, 2520598 | |
Contact: Study Coordinator +56992369820 | |
France | |
Hôpital Saint-Louis ( Site 0304) | Recruiting |
Paris, France, 75010 | |
Contact: Study Coordinator +33633211534 | |
Germany | |
klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Sit | Recruiting |
Munich, Bayern, Germany, 81675 | |
Contact: Study Coordinator 498941402522 | |
Poland | |
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0801) | Recruiting |
Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796 | |
Contact: Study Coordinator 48501446778 | |
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0802) | Recruiting |
Koszalin, Zachodniopomorskie, Poland, 75-581 | |
Contact: Study Coordinator 943488930 | |
Spain | |
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1003) | Recruiting |
Pozuelo de Alarcon, Madrid, Spain, 28223 | |
Contact: Study Coordinator +34914521987 | |
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 1001) | Recruiting |
Sevilla, Spain, 41013 | |
Contact: Study Coordinator +34955012000 |
Study Director: | Medical Director | Merck Sharp & Dohme LLC |
Responsible Party: | Merck Sharp & Dohme LLC |
ClinicalTrials.gov Identifier: | NCT06305767 |
Other Study ID Numbers: |
V940-005 V940-005 ( Other Identifier: Merck ) U1111-1292-1952 ( Other Identifier: WHO ) 2023-505658-17 ( Other Identifier: EU CT ) |
First Posted: | March 12, 2024 Key Record Dates |
Last Update Posted: | May 10, 2024 |
Last Verified: | May 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf |
URL: | http://engagezone.msd.com/ds_documentation.php |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Programmed Cell Death-1 (PD1, PD-1) Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1) Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2) |
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases |
Urinary Bladder Diseases Urologic Diseases Male Urogenital Diseases Pembrolizumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |