A Clinical Study of Intismeran Autogene (V940) Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005)
NCT ID: NCT06305767
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
230 participants
INTERVENTIONAL
2024-03-28
2031-10-20
Brief Summary
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The goals of this study are to learn if people who receive intismeran autogene and pembrolizumab are alive and cancer free longer than those who receive placebo and pembrolizumab, and to learn about the safety of intismeran autogene, pembrolizumab, and EV, and if people tolerate them.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
The Phase 1 Perioperative Cohort of this study has a single arm into which eligible participants are allocated. It will evaluate safety and preliminary efficacy of perioperative (neoadjuvant and adjuvant) intismeran autogene in combination with pembrolizumab plus EV for participants with muscle-invasive bladder cancer (MIBC).
TREATMENT
DOUBLE
The Phase 1 Perioperative Cohort will be conducted as an open-label study. Participants and investigators will be aware of the intervention assignments.
Study Groups
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Adjuvant Cohort: Pembrolizumab + Intismeran autogene
Adjuvant Cohort participants receive adjuvant treatment with up to 9 cycles of pembrolizumab plus up to a total of 9 doses of intismeran autogene. Intismeran autogene doses may begin as soon as Day 22 of Cycle 1. The total duration of treatment is up to approximately 13 months.
Pembrolizumab
Administered via intravenous (IV) infusion at a dose of 400 mg on Day 1 of every 6-week cycle for up to 9 adjuvant cycles for Adjuvant Cohort participants, or at a dose of 200 mg on Day 1 of every cycle for up to four 3-week neoadjuvant cycles and up to thirteen 3-week adjuvant cycles for Perioperative Cohort participants.
Intismeran autogene
Administered via intramuscular (IM) injection at a dose of 1 mg every 3 weeks for a total of up to 9 adjuvant doses for Adjuvant Cohort participants, or at a dose of 1 mg every 3 weeks for a total of up to 9 doses in the neoadjuvant and adjuvant periods for Perioperative Cohort participants.
Adjuvant Cohort: Pembrolizumab + Placebo
Adjuvant Cohort participants receive adjuvant treatment with up to 9 cycles of pembrolizumab plus up to a total of 9 doses of placebo. Placebo doses may begin as soon as Day 22 of Cycle 1. The total duration of treatment is up to approximately 13 months.
Pembrolizumab
Administered via intravenous (IV) infusion at a dose of 400 mg on Day 1 of every 6-week cycle for up to 9 adjuvant cycles for Adjuvant Cohort participants, or at a dose of 200 mg on Day 1 of every cycle for up to four 3-week neoadjuvant cycles and up to thirteen 3-week adjuvant cycles for Perioperative Cohort participants.
Placebo
Intismeran autogene diluent only (saline and/or dextrose) administered via IM injection Q3W for up to 9 doses.
Perioperative Cohort: Pembrolizumab + Intismeran autogene + EV and Surgery
Participants will receive neoadjuvant treatment with up to 4 cycles of pembrolizumab plus EV and 1 to 4 doses of intismeran autogene, followed by radical cystectomy \[RC\] plus pelvic lymph node dissection \[PLND\], and then adjuvant treatment with up to 13 cycles of pembrolizumab plus up to 5 cycles of EV and 5 to 8 doses of intismeran autogene (for a total of 9 neoadjuvant plus adjuvant Intismeran autogene doses), or until any of the protocol-specified criteria for discontinuation of study intervention are met. The total duration of treatment is up to approximately 16 months.
Pembrolizumab
Administered via intravenous (IV) infusion at a dose of 400 mg on Day 1 of every 6-week cycle for up to 9 adjuvant cycles for Adjuvant Cohort participants, or at a dose of 200 mg on Day 1 of every cycle for up to four 3-week neoadjuvant cycles and up to thirteen 3-week adjuvant cycles for Perioperative Cohort participants.
Intismeran autogene
Administered via intramuscular (IM) injection at a dose of 1 mg every 3 weeks for a total of up to 9 adjuvant doses for Adjuvant Cohort participants, or at a dose of 1 mg every 3 weeks for a total of up to 9 doses in the neoadjuvant and adjuvant periods for Perioperative Cohort participants.
Enfortumab Vedotin
Administered via IV infusion at a dose of 1.25 mg/kg on Day 1 and Day 8 of every cycle for up to four 3-week neoadjuvant cycles and up to five 3-week adjuvant cycles for Perioperative Cohort participants.
Surgery (RC plus PLND)
Curative intent surgery (RC plus PLND) will be administered to all participants in the Perioperative Cohort and will be done in accordance with the American Urological Association/American Society for Radiation Oncology/American Society of Clinical Oncology/Society of Urologic Oncology guidelines. RC plus PLND will be performed within 6 weeks of the last dose of neoadjuvant intismeran autogene plus pembrolizumab plus EV treatment. Adjuvant intismeran autogene plus pembrolizumab plus EV treatment will begin within 8 weeks of completing RC plus PLND.
Interventions
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Pembrolizumab
Administered via intravenous (IV) infusion at a dose of 400 mg on Day 1 of every 6-week cycle for up to 9 adjuvant cycles for Adjuvant Cohort participants, or at a dose of 200 mg on Day 1 of every cycle for up to four 3-week neoadjuvant cycles and up to thirteen 3-week adjuvant cycles for Perioperative Cohort participants.
Intismeran autogene
Administered via intramuscular (IM) injection at a dose of 1 mg every 3 weeks for a total of up to 9 adjuvant doses for Adjuvant Cohort participants, or at a dose of 1 mg every 3 weeks for a total of up to 9 doses in the neoadjuvant and adjuvant periods for Perioperative Cohort participants.
Placebo
Intismeran autogene diluent only (saline and/or dextrose) administered via IM injection Q3W for up to 9 doses.
Enfortumab Vedotin
Administered via IV infusion at a dose of 1.25 mg/kg on Day 1 and Day 8 of every cycle for up to four 3-week neoadjuvant cycles and up to five 3-week adjuvant cycles for Perioperative Cohort participants.
Surgery (RC plus PLND)
Curative intent surgery (RC plus PLND) will be administered to all participants in the Perioperative Cohort and will be done in accordance with the American Urological Association/American Society for Radiation Oncology/American Society of Clinical Oncology/Society of Urologic Oncology guidelines. RC plus PLND will be performed within 6 weeks of the last dose of neoadjuvant intismeran autogene plus pembrolizumab plus EV treatment. Adjuvant intismeran autogene plus pembrolizumab plus EV treatment will begin within 8 weeks of completing RC plus PLND.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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ModernaTX, Inc.
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 0104)
Los Angeles, California, United States
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0102)
Orlando, Florida, United States
University of Chicago Medical Center ( Site 0109)
Chicago, Illinois, United States
University of Iowa ( Site 0110)
Iowa City, Iowa, United States
Icahn School of Medicine at Mount Sinai ( Site 0101)
New York, New York, United States
Duke Cancer Institute ( Site 0107)
Durham, North Carolina, United States
Cleveland Clinic Main ( Site 0100)
Cleveland, Ohio, United States
Fox Chase Cancer Center ( Site 0106)
Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center ( Site 0103)
Dallas, Texas, United States
Houston Methodist Hospital-Department of Urology ( Site 0111)
Houston, Texas, United States
Macquarie University-MQ Health Clinical Trials Unit ( Site 1803)
Macquarie University, New South Wales, Australia
Westmead Hospital ( Site 1802)
Westmead, New South Wales, Australia
Mater Misericordiae Limited ( Site 1808)
South Brisbane, Queensland, Australia
One Clinical Research ( Site 1807)
Nedlands, Western Australia, Australia
BC Cancer Vancouver ( Site 0004)
Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre ( Site 0003)
Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal ( Site 0005)
Montreal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0001)
Québec, Quebec, Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0002)
Sherbrooke, Quebec, Canada
Bradfordhill-Clinical Area ( Site 1501)
Recoleta, Santiago, Region M. de Santiago, Chile
FALP ( Site 1500)
Santiago, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile ( Site 1503)
Santiago, Region M. de Santiago, Chile
CIDO SpA ( Site 1509)
Temuco, Región de la Araucanía, Chile
ONCOCENTRO APYS-ACEREY ( Site 1506)
Viña del Mar, Región de Valparaíso, Chile
Clínica Universitaria Colombia ( Site 1600)
Bogotá, Bogota D.C., Colombia
Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1605)
Valledupar, Cesar Department, Colombia
Instituto Nacional De Cancerologia-Oncología Clínica ( Site 1606)
Bogota, Cundinamarca, Colombia
Fundacion Valle del Lili- CIC-Oncology CIC ( Site 1608)
Cali, Valle del Cauca Department, Colombia
Oncopole Claudius Regaud ( Site 0302)
Toulouse, Haute-Garonne, France
Institut de Cancérologie de l'Ouest ( Site 0300)
Angers, Maine-et-Loire, France
Hopital Claude Huriez - CHU de Lille ( Site 0301)
Lille, Nord, France
Hôpital Saint-Louis ( Site 0304)
Paris, , France
Gustave Roussy ( Site 0303)
Villejuif, Île-de-France Region, France
klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0401)
Munich, Bavaria, Germany
Caritas-Krankenhaus St. Josef-Klinik fuer Urologie ( Site 0404)
Regensburg, Bavaria, Germany
Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 0405)
Dresden, Saxony, Germany
Universitätsklinikum Halle-Universitätsklinik und Poliklinik für Urologie ( Site 0402)
Halle, Saxony-Anhalt, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0400)
Berlin, , Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0504)
Rome, Lazio, Italy
Ospedale San Martino-U.O. Oncologia Medica 1 ( Site 0500)
Genoa, Liguria, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0502)
Milan, Lombardy, Italy
Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli-UOSC Oncologia ( Site 0503)
Naples, Napoli, Italy
Ospedale San Raffaele-Oncologia Medica ( Site 0501)
Milan, , Italy
Auckland City Hospital ( Site 1901)
Auckland, , New Zealand
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 1702)
Lima, , Peru
Oncosalud ( Site 1701)
Lima, , Peru
Hospital Militar Central Luis Arias Schereiber ( Site 1700)
Lima, , Peru
Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k ( Site 0805)
Poznan, Greater Poland Voivodeship, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0801)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Moczowego ( Site 0800)
Warsaw, Masovian Voivodeship, Poland
Oddzial Onkologii Klinicznej z Pododdzialem Chemioterapii Jednodniowej ( Site 0802)
Koszalin, West Pomeranian Voivodeship, Poland
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 0806)
Kielce, Świętokrzyskie Voivodeship, Poland
Korea University Anam Hospital ( Site 2002)
Seoul, , South Korea
Seoul National University Hospital-Urology ( Site 2000)
Seoul, , South Korea
Samsung Medical Center-Urology ( Site 2001)
Seoul, , South Korea
Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 1006)
Badalona, Barcelona, Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1003)
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1005)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitari Vall d'Hebron-Oncology ( Site 1002)
Barcelona, , Spain
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 1001)
Seville, , Spain
Karolinska Universitetssjukhuset Solna ( Site 1101)
Stockholm, Stockholm County, Sweden
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1102)
Uppsala, Uppsala County, Sweden
Hacettepe Universite Hastaneleri-oncology hospital ( Site 1200)
Ankara, , Turkey (Türkiye)
Memorial Ankara Hastanesi-Medical Oncology ( Site 1204)
Ankara, , Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1201)
Ankara, , Turkey (Türkiye)
Koc Universitesi Hastanesi ( Site 1206)
Istanbul, , Turkey (Türkiye)
T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training ( Site 1205)
Istanbul, , Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1202)
Istanbul, , Turkey (Türkiye)
Ege Universitesi Hastanesi-Medical Oncology ( Site 1203)
Izmir, , Turkey (Türkiye)
Torbay Hospital ( Site 1303)
Torquay, Devon, United Kingdom
Royal Free Hospital ( Site 1300)
London, England, United Kingdom
Gartnavel General Hospital-Clinical Trials Unit ( Site 1301)
Glasgow, Glasgow City, United Kingdom
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1302)
London, London, City of, United Kingdom
The Christie NHS Foundation Trust ( Site 1306)
Manchester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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V940-005
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1292-1952
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-505658-17-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
INTerpath-005
Identifier Type: OTHER
Identifier Source: secondary_id
V940-005
Identifier Type: -
Identifier Source: org_study_id