A Phase 2 Open-label Randomized Study of V940 in Combination With BCG Versus BCG Monotherapy in Participants With High-risk Non-muscle Invasive Bladder Cancer (INTerpath-011)

Status: Recruiting
Location: See all (82) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Researchers are looking for new ways to treat people with high-risk non-muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the bladder. High-risk means NMIBC may have a high chance of getting worse or coming back after treatment. HR NMIBC can also include carcinoma in situ (CIS). CIS is bladder cancer that appears flat and is only in the inner layer (surface) of the bladder. CIS is not raised and is not growing toward the center of the bladder. The standard treatment for HR NMIBC is a procedure to remove the tumor called transurethral resection of the bladder tumor (TURBT) followed by Bacillus Calmette-Guerin (BCG). Standard treatment is something that is considered the first line of treatment for a condition. BCG is an immunotherapy, which is a treatment that helps the immune system fight cancer. However, BCG may not work to treat HR NMIBC in some people. Researchers want to learn if adding intismeran autogene, the study treatment, to standard treatment can help treat HR NMIBC. Intismeran autogene is designed to help a person's immune system attack their specific cancer. The goals of this study are to learn: * If people who receive intismeran autogene with BCG live longer without the cancer growing, spreading, or coming back, or dying from any cause, compared to people who receive BCG alone * If more people who receive intismeran autogene with BCG have their cancer go away (complete response), compared to people who receive BCG alone * How many people who receive intismeran autogene without BCG have their cancer go away

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

⁃ The main inclusion criteria include but are not limited to the following:

⁃ \- Is an individual whose most recent TURBT was performed within 12 weeks before randomization/allocation and showed BICR-confirmed high-risk NMIBC histology

⁃ BCG Arms:

• Has high-risk non-muscle invasive (HG Ta, T1, and/or CIS) UC of the bladder

• Is BCG-naïve defined as either having never received BCG or having received BCG more than 2 years before high-risk NMIBC recurrence. Recurrence must be at least 24 months from the last exposure to BCG with evidence of complete response during the 2-year period post BCG

⁃ Intismeran autogene Monotherapy Arm:

• Has CIS +/-papillary non-muscle invasive UC of the bladder

• Is ineligible for, or refusing, any IVESIC therapy

• Is either BCG-naïve (as defined above) or BCG-exposed but did not receive protocol-specified minimum dosing of BCG and experienced recurrence of high-risk NMIBC within 2 years of the last dose of BCG

• Human immunodeficiency virus (HIV)-infected individuals must have well controlled HIV on antiretroviral therapy (ART)

Locations
United States
California
Michael G Oefelein Clinical Trials ( Site 0138)
RECRUITING
Bakersfield
Genesis Research, LLC ( Site 0141)
ACTIVE_NOT_RECRUITING
Los Alamitos
USC Norris Comprehensive Cancer Center ( Site 0123)
RECRUITING
Los Angeles
Genesis Healthcare-Torrance ( Site 0140)
RECRUITING
Torrance
Genesis Research LLC ( Site 0118)
RECRUITING
Torrance
Colorado
Urology Associates ( Site 0144)
RECRUITING
Littleton
Florida
Urological Research Network ( Site 0133)
RECRUITING
Hialeah
Illinois
Associated Urological Specialists - Chicago Ridge ( Site 0139)
RECRUITING
Chicago Ridge
Louisiana
Southern Urology, LLC ( Site 0145)
RECRUITING
Lafayette
Missouri
University of Missouri Health Care ( Site 0126)
RECRUITING
Columbia
Nebraska
NHO Revive Research Institute, LLC ( Site 0137)
RECRUITING
Lincoln
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0111)
RECRUITING
New York
Ohio
TriState Urologic Services PSC Inc. dba The Urology Group ( Site 0122)
RECRUITING
Cincinnati
Oregon
OHSU Knight Cancer Institute - South Waterfront ( Site 0110)
RECRUITING
Portland
Pennsylvania
MidLantic Urology ( Site 0102)
RECRUITING
Bala-cynwyd
Tennessee
The Conrad Pearson Clinic ( Site 0143)
RECRUITING
Germantown
Texas
Urology Austin, PLLC ( Site 0109)
RECRUITING
Austin
Virginia
Urology of Virginia ( Site 0125)
RECRUITING
Virginia Beach
Washington
University of Washington - Fred Hutchinson Cancer Center ( Site 0100)
RECRUITING
Seattle
Other Locations
Argentina
Asociación de Beneficencia Hospital Sirio Libanés ( Site 0303)
RECRUITING
Buenos Aires
Hospital Italiano de Buenos Aires ( Site 0307)
RECRUITING
Caba
Instituto Alexander Fleming ( Site 0306)
RECRUITING
Ciudad Autónoma De Buenos Aires
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0301)
RECRUITING
La Rioja
Instituto de Investigaciones Clinicas Mar dle Plata ( Site 0305)
RECRUITING
Mar Del Plata
Fundacion Estudios Clinicos ( Site 0304)
RECRUITING
Rosario
Sanatorio Parque ( Site 0300)
RECRUITING
Rosario
Australia
Macquarie University ( Site 1801)
RECRUITING
Macquarie University
Fiona Stanley Hospital ( Site 1803)
RECRUITING
Perth
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0400)
RECRUITING
Barretos
Instituto do Câncer e Transplante de Curitiba ( Site 0402)
RECRUITING
Curitiba
Hospital de Clínicas de Passo Fundo ( Site 0406)
RECRUITING
Passo Fundo
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0410)
RECRUITING
São Jose Do Rio Preto
Canada
The Moncton Hospital-Oncology ( Site 0200)
RECRUITING
Moncton
CIUSSS de l'Estrie-CHUS ( Site 0204)
RECRUITING
Sherbrooke
Chile
Bradford Hill Norte ( Site 0503)
RECRUITING
Antofagasta
Bradfordhill ( Site 0501)
RECRUITING
Santiago
FALP ( Site 0500)
RECRUITING
Santiago
Pontificia Universidad Catolica de Chile ( Site 0502)
RECRUITING
Santiago
Oncocentro Valdivia ( Site 0507)
RECRUITING
Valdivia
ONCOCENTRO APYS ( Site 0505)
RECRUITING
Valparaíso
Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0603)
RECRUITING
Bogotá
Instituto de Cancerología ( Site 0600)
RECRUITING
Medellín
IMAT S.A.S ( Site 0601)
RECRUITING
Montería
Oncólogos del Occidente S.A.S. - Sede Pereira ( Site 0604)
RECRUITING
Pereira
Clínica Imbanaco S.A.S ( Site 0602)
RECRUITING
Santiago De Cali
Denmark
Herlev and Gentofte Hospital ( Site 3101)
RECRUITING
Herlev
France
Bordeaux University Hospital - Pellegrin ( Site 0806)
RECRUITING
Bordeaux
CHU Dijon Bourgogne ( Site 0802)
RECRUITING
Dijon
Hôpital Saint-Louis ( Site 0807)
RECRUITING
Paris
CHU de Rouen- urology ( Site 0803)
RECRUITING
Rouen
Hôpital Foch-Urology department ( Site 0801)
RECRUITING
Suresnes
Germany
Universitaetsklinikum Halle ( Site 0902)
RECRUITING
Halle
Marienhospital Herne ( Site 0907)
RECRUITING
Herne
Universitaetsklinikum Jena ( Site 0903)
RECRUITING
Jena
Klinikum der Universität München Großhadern ( Site 0910)
RECRUITING
Munich
Greece
Henry Dunant Hospital ( Site 1005)
RECRUITING
Athens
Metropolitan General Hospital ( Site 1001)
RECRUITING
Athens
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1000)
RECRUITING
Chaidari/athens
European Interbalkan Medical Center-Oncology Department ( Site 1008)
RECRUITING
Thessaloniki
Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 1112)
RECRUITING
Debrecen
Gyor- Moson- Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz ( Site 1116)
RECRUITING
Győr
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaza ( Site 1117)
RECRUITING
Nyíregyháza
Szegedi Tudomanyegyetem ( Site 1113)
RECRUITING
Szeged
Italy
Azienda USL 8 di Arezzo ( Site 1203)
RECRUITING
Arezzo
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1202)
RECRUITING
Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1200)
RECRUITING
Roma
Istituto Nazionale Tumori Regina Elena ( Site 1201)
RECRUITING
Rome
Netherlands
Rijnstate ( Site 1307)
RECRUITING
Arnhem
Erasmus MC ( Site 1300)
RECRUITING
Rotterdam
Peru
Hospital Militar Central Luis Arias Schereiber ( Site 0700)
RECRUITING
Lima
Oncosalud ( Site 0701)
RECRUITING
Lima
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0702)
RECRUITING
San Isidro
Poland
Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k ( Site 1402)
RECRUITING
Poznan
Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 1404)
RECRUITING
Tarnów
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Moczowego ( Site 1401)
RECRUITING
Warszawa
Spain
Hospital Insular de Gran Canaria ( Site 1502)
RECRUITING
Las Palmas De Gran Canaria
Hospital Clinico San Carlos... ( Site 1500)
RECRUITING
Madrid
Hospital Universitario 12 de Octubre ( Site 1507)
RECRUITING
Madrid
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1506)
RECRUITING
Madrid
Hospital Universitari Parc Tauli ( Site 1505)
RECRUITING
Sabadell
Hospital Universitario Virgen Macarena ( Site 1504)
RECRUITING
Seville
United Kingdom
St Bartholomew s Hospital ( Site 1700)
RECRUITING
London
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-03-11
Estimated Completion Date: 2031-09-03
Participants
Target number of participants: 308
Treatments
Experimental: Intismeran autogene + BCG
Participants receive 1 mg of intismeran autogene via intramuscular (IM) injection every 3 weeks (Q3W) for 9 doses. Participants also receive 50 mg of TICE® BCG once weekly for 6 weeks, then once weekly on weeks 13-15, 25-27, 49-51, and 73-75.
Active_comparator: BCG
Participants receive 50 mg of TICE® BCG once weekly for 6 weeks, then once weekly on weeks 13-15, 25-27, 49-51, and 73-75.
Experimental: Intismeran autogene
Participants receive 1 mg of intismeran autogene via intramuscular (IM) injection every 3 weeks (Q3W) for 9 doses.
Related Therapeutic Areas
Sponsors
Collaborators: ModernaTX, Inc.
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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