A Phase 1/2 Study of V940 Plus Pembrolizumab With or Without Enfortumab Vedotin in Muscle-Invasive Urothelial Carcinoma (MIUC) (INTerpath-005)

Status: Recruiting
Location: See all (74) locations...
Intervention Type: Procedure, Biological, Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

Researchers are looking for new ways to treat people with high-risk muscle-invasive urothelial carcinoma (MIUC). Urothelial carcinoma is a type of bladder cancer that begins in cells that line the inside of the bladder and other parts of the urinary tract, such as part of the kidneys, ureters, and urethra. People with MIUC usually have chemotherapy before surgery, then surgery to remove the cancer. Chemotherapy is a type of medicine to destroy cancer cells or stop them from growing. After surgery, some people receive more treatment to prevent cancer from returning. Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. Enfortumab vedotin (EV) is an antibody drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. Researchers want to learn if giving intismeran autogene (the study treatment) with pembrolizumab can prevent MIUC from returning after surgery. Intismeran autogene (also called mRNA-4157) is designed to treat each person's cancer by helping the person's immune system identify and kill cancer cells based on certain proteins found on those cancer cells. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
United States
California
UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 0104)
RECRUITING
Los Angeles
Florida
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0102)
RECRUITING
Orlando
Iowa
University of Iowa ( Site 0110)
RECRUITING
Iowa City
Illinois
University of Chicago Medical Center ( Site 0109)
RECRUITING
Chicago
North Carolina
Duke Cancer Institute ( Site 0107)
RECRUITING
Durham
New York
Icahn School of Medicine at Mount Sinai ( Site 0101)
RECRUITING
New York
Ohio
Cleveland Clinic Main ( Site 0100)
RECRUITING
Cleveland
Pennsylvania
Fox Chase Cancer Center ( Site 0106)
RECRUITING
Philadelphia
Texas
UT Southwestern Medical Center ( Site 0103)
RECRUITING
Dallas
Houston Methodist Hospital-Department of Urology ( Site 0111)
RECRUITING
Houston
Other Locations
Australia
Macquarie University-MQ Health Clinical Trials Unit ( Site 1803)
RECRUITING
Macquarie University
One Clinical Research ( Site 1807)
RECRUITING
Nedlands
Mater Misericordiae Limited ( Site 1808)
RECRUITING
South Brisbane
Westmead Hospital ( Site 1802)
COMPLETED
Westmead
Canada
Centre Hospitalier de l'Université de Montréal ( Site 0005)
RECRUITING
Montreal
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0001)
RECRUITING
Québec
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0002)
RECRUITING
Sherbrooke
Princess Margaret Cancer Centre ( Site 0003)
RECRUITING
Toronto
BC Cancer Vancouver ( Site 0004)
RECRUITING
Vancouver
Chile
Bradfordhill-Clinical Area ( Site 1501)
RECRUITING
Recoleta, Santiago
FALP ( Site 1500)
RECRUITING
Santiago
Pontificia Universidad Catolica de Chile ( Site 1503)
RECRUITING
Santiago
CIDO SpA ( Site 1509)
RECRUITING
Temuco
ONCOCENTRO APYS-ACEREY ( Site 1506)
RECRUITING
Viña Del Mar
Colombia
Instituto Nacional De Cancerologia-Oncología Clínica ( Site 1606)
ACTIVE_NOT_RECRUITING
Bogota
Clínica Universitaria Colombia ( Site 1600)
RECRUITING
Bogotá
Fundacion Valle del Lili- CIC-Oncology CIC ( Site 1608)
ACTIVE_NOT_RECRUITING
Santiago De Cali
Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1605)
RECRUITING
Valledupar
France
Institut de Cancérologie de l'Ouest ( Site 0300)
RECRUITING
Angers
Hopital Claude Huriez - CHU de Lille ( Site 0301)
ACTIVE_NOT_RECRUITING
Lille
Hôpital Saint-Louis ( Site 0304)
RECRUITING
Paris
Oncopole Claudius Regaud ( Site 0302)
RECRUITING
Toulouse
Gustave Roussy ( Site 0303)
ACTIVE_NOT_RECRUITING
Villejuif
Germany
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0400)
RECRUITING
Berlin
Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 0405)
RECRUITING
Dresden
Universitätsklinikum Halle-Universitätsklinik und Poliklinik für Urologie ( Site 0402)
RECRUITING
Halle
klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0401)
RECRUITING
Munich
Caritas-Krankenhaus St. Josef-Klinik fuer Urologie ( Site 0404)
RECRUITING
Regensburg
Italy
Ospedale San Martino-U.O. Oncologia Medica 1 ( Site 0500)
RECRUITING
Genoa
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0502)
RECRUITING
Milan
Ospedale San Raffaele-Oncologia Medica ( Site 0501)
RECRUITING
Milan
Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli-UOSC Oncologia ( Site 0503)
RECRUITING
Naples
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0504)
RECRUITING
Rome
New Zealand
Auckland City Hospital ( Site 1901)
ACTIVE_NOT_RECRUITING
Auckland
Peru
Hospital Militar Central Luis Arias Schereiber ( Site 1700)
RECRUITING
Lima
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 1702)
ACTIVE_NOT_RECRUITING
Lima
Oncosalud ( Site 1701)
RECRUITING
Lima
Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0801)
ACTIVE_NOT_RECRUITING
Bydgoszcz
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 0806)
RECRUITING
Kielce
Oddzial Onkologii Klinicznej z Pododdzialem Chemioterapii Jednodniowej ( Site 0802)
ACTIVE_NOT_RECRUITING
Koszalin
Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k ( Site 0805)
RECRUITING
Poznan
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Moczowego ( Site 0800)
RECRUITING
Warsaw
Republic of Korea
Korea University Anam Hospital ( Site 2002)
ACTIVE_NOT_RECRUITING
Seoul
Samsung Medical Center-Urology ( Site 2001)
ACTIVE_NOT_RECRUITING
Seoul
Seoul National University Hospital-Urology ( Site 2000)
ACTIVE_NOT_RECRUITING
Seoul
Spain
Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 1006)
RECRUITING
Badalona
Hospital Universitari Vall d'Hebron-Oncology ( Site 1002)
RECRUITING
Barcelona
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1005)
RECRUITING
Madrid
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1003)
RECRUITING
Pozuelo De Alarcón
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 1001)
RECRUITING
Seville
Sweden
Karolinska Universitetssjukhuset Solna ( Site 1101)
RECRUITING
Stockholm
Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1102)
ACTIVE_NOT_RECRUITING
Uppsala
Turkey
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1201)
RECRUITING
Ankara
Hacettepe Universite Hastaneleri-oncology hospital ( Site 1200)
ACTIVE_NOT_RECRUITING
Ankara
Memorial Ankara Hastanesi-Medical Oncology ( Site 1204)
ACTIVE_NOT_RECRUITING
Ankara
Koc Universitesi Hastanesi ( Site 1206)
RECRUITING
Istanbul
T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training ( Site 1205)
ACTIVE_NOT_RECRUITING
Istanbul
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1202)
RECRUITING
Istanbul
Ege Universitesi Hastanesi-Medical Oncology ( Site 1203)
ACTIVE_NOT_RECRUITING
Izmir
United Kingdom
Gartnavel General Hospital-Clinical Trials Unit ( Site 1301)
ACTIVE_NOT_RECRUITING
Glasgow
Royal Free Hospital ( Site 1300)
ACTIVE_NOT_RECRUITING
London
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1302)
ACTIVE_NOT_RECRUITING
London
The Christie NHS Foundation Trust ( Site 1306)
RECRUITING
Manchester
Torbay Hospital ( Site 1303)
RECRUITING
Torquay
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2024-03-28
Estimated Completion Date: 2031-10-20
Participants
Target number of participants: 230
Treatments
Experimental: 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.
Active_comparator: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Collaborators: ModernaTX, Inc.
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov