Actively Recruiting
A Study of Intismeran Autogene (V940) With BCG Compared to BCG Alone in People With High-risk Non-muscle Invasive Bladder Cancer
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-28
308
Participants Needed
89
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Merck Sharp & Dohme LLC
Lead Sponsor
M
ModernaTX, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating new treatment options for people with high-risk non-muscle invasive bladder cancer (HR NMIBC), a type of bladder cancer that affects the inner lining of the bladder but has not spread to the muscle or beyond. This includes carcinoma in situ (CIS), a flat form of bladder cancer limited to the bladder's surface. The study aims to find out if adding intismeran autogene, an immune system-targeting treatment, to the standard Bacillus Calmette-Guerin (BCG) therapy can improve outcomes for people with HR NMIBC by helping the immune system attack the cancer more effectively. Participants are assigned to different groups. One group receives both intismeran autogene by intramuscular injection every three weeks for nine doses along with BCG treatment given once weekly for six weeks, followed by additional weekly doses at later weeks. Another group receives BCG alone on the same schedule, while a third group receives only intismeran autogene. The study compares these treatments to see if the combination improves survival without cancer growth, spread, or return. During the study, participants will be monitored for up to approximately five years to track event-free survival, recurrence-free survival, overall survival, and other outcomes. Researchers will also evaluate adverse events and treatment tolerability. Follow-up includes assessments at regular intervals to observe disease status and safety. The total participation time may last several years to gather long-term data on treatment effects.
CONDITIONS
Brief Title
A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Most recent tumor removal by TURBT within 12 weeks before randomization with confirmed high-risk non-muscle invasive bladder cancer
- For Cohort A: High-risk non-muscle invasive urothelial carcinoma (HG Ta, T1, and/or CIS) of the bladder
- BCG-nafve for Cohort A, defined as never having received BCG or last BCG more than 2 years before recurrence with complete response during that period
- For Cohort B: CIS with or without papillary non-muscle invasive urothelial carcinoma
- Ineligible for or refusing any intravesical therapy for Cohort B
- BCG-nafve or BCG-exposed but with incomplete dosing and recurrence within 2 years for Cohort B
- HIV-infected individuals must have well-controlled HIV on antiretroviral therapy
You will not qualify if you...
- History or current locally advanced or metastatic urothelial carcinoma
- Concurrent or recent extravesical non-muscle invasive urothelial carcinoma within 2 years, with exceptions
- Additional malignancy progressing or treated within last 3 years
- Myocardial infarction within 6 months before randomization
- Systemic anticancer therapy including investigational agents within 4 weeks before randomization
- Prior cancer vaccine treatment
- Immunodeficiency or chronic systemic steroid therapy
- Active autoimmune disease requiring systemic treatment in last 2 years
- Contraindication to intravenous contrast or gadolinium or inability to undergo CT or MR urography
- For Cohort A: Active tuberculosis or known HIV infection
- For Cohort B: HIV-infected individuals with history of Kaposi's sarcoma or Multicentric Castleman's Disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 75 weeks
Participants receive Intismeran autogene via intramuscular injection every 3 weeks for 9 doses and/or BCG intravesical instillations weekly according to cohort assignment.
Weekly visits during BCG instillation weeks and visits every 3 weeks for Intismeran autogene injections
Duration - Up to approximately 5 years
Participants are monitored for event-free survival, recurrence-free survival, and overall survival for up to approximately 5 years after treatment.
Periodic visits for outcome assessments
Trial Site Locations
Total: 89 locations
1
Michael G Oefelein Clinical Trials ( Site 0138)
Bakersfield, California, United States, 93301
Actively Recruiting
2
Genesis Research, LLC ( Site 0141)
Los Alamitos, California, United States, 90720
Active, Not Recruiting
3
USC Norris Comprehensive Cancer Center ( Site 0123)
Los Angeles, California, United States, 90033
Actively Recruiting
4
Genesis Healthcare-Torrance ( Site 0140)
Torrance, California, United States, 90503
Actively Recruiting
5
Genesis Research LLC ( Site 0118)
Torrance, California, United States, 90505
Actively Recruiting
6
Urology Associates ( Site 0144)
Littleton, Colorado, United States, 80122
Actively Recruiting
7
Urological Research Network ( Site 0133)
Hialeah, Florida, United States, 33016
Actively Recruiting
8
Associated Urological Specialists - Chicago Ridge ( Site 0139)
Chicago Ridge, Illinois, United States, 60415
Actively Recruiting
9
Southern Urology, LLC ( Site 0145)
Lafayette, Louisiana, United States, 70508
Actively Recruiting
10
University of Missouri Health Care ( Site 0126)
Columbia, Missouri, United States, 65212
Actively Recruiting
11
NHO Revive Research Institute, LLC ( Site 0137)
Lincoln, Nebraska, United States, 68506
Actively Recruiting
12
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0111)
New York, New York, United States, 10016
Actively Recruiting
13
TriState Urologic Services PSC Inc. dba The Urology Group ( Site 0122)
Cincinnati, Ohio, United States, 45212
Actively Recruiting
14
OHSU Knight Cancer Institute - South Waterfront ( Site 0110)
Portland, Oregon, United States, 97239
Actively Recruiting
15
MidLantic Urology ( Site 0102)
Bala-Cynwyd, Pennsylvania, United States, 19004
Actively Recruiting
16
The Conrad Pearson Clinic ( Site 0143)
Germantown, Tennessee, United States, 38138
Actively Recruiting
17
Texas Oncology-Austin Central ( Site 0107)
Austin, Texas, United States, 78705
Actively Recruiting
18
Urology Austin, PLLC ( Site 0109)
Austin, Texas, United States, 78759
Actively Recruiting
19
Urology of Virginia ( Site 0125)
Virginia Beach, Virginia, United States, 23462
Actively Recruiting
20
University of Washington - Fred Hutchinson Cancer Center ( Site 0100)
Seattle, Washington, United States, 98195
Actively Recruiting
21
Hospital Italiano de Buenos Aires ( Site 0307)
CABA, Buenos Aires, Argentina, C1199ABD
Actively Recruiting
22
Instituto Alexander Fleming ( Site 0306)
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
Actively Recruiting
23
Instituto de Investigaciones Clinicas Mar de Plata ( Site 0305)
Mar del Plata, Buenos Aires, Argentina, B7600FZO
Actively Recruiting
24
Asociación de Beneficencia Hospital Sirio Libanés ( Site 0303)
Buenos Aires, Buenos Aires F.D., Argentina, C1419AHN
Actively Recruiting
25
Fundacion Estudios Clinicos ( Site 0304)
Rosario, Santa Fe Province, Argentina, S2000DEJ
Actively Recruiting
26
Sanatorio Parque ( Site 0300)
Rosario, Santa Fe Province, Argentina, S2000DSV
Actively Recruiting
27
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0301)
La Rioja, Argentina, F5300COE
Actively Recruiting
28
Macquarie University ( Site 1801)
Macquarie University, New South Wales, Australia, 2109
Actively Recruiting
29
Fiona Stanley Hospital ( Site 1803)
Perth, Western Australia, Australia, 6150
Actively Recruiting
30
Instituto do Câncer e Transplante de Curitiba ( Site 0402)
Curitiba, Paraná, Brazil, 80510-130
Actively Recruiting
31
Hospital de Clínicas de Passo Fundo ( Site 0406)
Passo Fundo, Rio Grande do Sul, Brazil, 99010-260
Actively Recruiting
32
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0400)
Barretos, São Paulo, Brazil, 14784-400
Actively Recruiting
33
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0410)
São Jose Do Rio Preto, São Paulo, Brazil, 15090-000
Actively Recruiting
34
The Moncton Hospital-Oncology ( Site 0200)
Moncton, New Brunswick, Canada, E1C 6Z8
Actively Recruiting
35
CIUSSS de l'Estrie-CHUS ( Site 0204)
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
36
Oncocentro Valdivia ( Site 0507)
Valdivia, Los Ríos Region, Chile, 5112129
Actively Recruiting
37
FALP ( Site 0500)
Santiago, Region M. de Santiago, Chile, 7500921
Actively Recruiting
38
Pontificia Universidad Catolica de Chile ( Site 0502)
Santiago, Region M. de Santiago, Chile, 8330032
Actively Recruiting
39
Bradfordhill ( Site 0501)
Santiago, Region M. de Santiago, Chile, 8420383
Actively Recruiting
40
ONCOCENTRO APYS ( Site 0505)
Viña del Mar, Valparaiso, Chile, 2520598
Actively Recruiting
41
Bradford Hill Norte ( Site 0503)
Antofagasta, Chile, 1240000
Actively Recruiting
42
Instituto de Cancerología ( Site 0600)
Medellín, Antioquia, Colombia, 050021
Actively Recruiting
43
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0603)
Bogotá, Bogota D.C., Colombia, 111321
Actively Recruiting
44
IMAT S.A.S ( Site 0601)
Montería, Departamento de Córdoba, Colombia, 230002
Actively Recruiting
45
Oncólogos del Occidente S.A.S. - Sede Pereira ( Site 0604)
Pereira, Risaralda Department, Colombia, 661001
Actively Recruiting
46
Clínica Imbanaco S.A.S ( Site 0602)
Cali, Valle del Cauca Department, Colombia
Actively Recruiting
47
Herlev and Gentofte Hospital ( Site 3101)
Herlev, Capital Region, Denmark, 2730
Actively Recruiting
48
CHU Dijon Bourgogne ( Site 0802)
Dijon, Cote-d Or, France, 21079
Actively Recruiting
49
Bordeaux University Hospital - Pellegrin ( Site 0806)
Bordeaux, Gironde, France, 33076
Actively Recruiting
50
CHU de Rouen- urology ( Site 0803)
Rouen, Haute-Normandie, France, 76031
Actively Recruiting
51
Hôpital Foch-Urology department ( Site 0801)
Suresnes, Hauts-de-Seine, France, 92150
Actively Recruiting
52
Hôpital Saint-Louis ( Site 0807)
Paris, Île-de-France Region, France, 75010
Actively Recruiting
53
Klinikum Stuttgart - Katharinenhospital ( Site 0909)
Stuttgart, Baden-Wurttemberg, Germany, 70174
Actively Recruiting
54
Klinikum der Universität München Großhadern ( Site 0910)
Munich, Bavaria, Germany, 81377
Actively Recruiting
55
Marienhospital Herne ( Site 0907)
Herne, North Rhine-Westphalia, Germany, 44625
Actively Recruiting
56
Universitaetsklinikum Halle ( Site 0902)
Halle, Saxony-Anhalt, Germany, 06120
Actively Recruiting
57
Universitaetsklinikum Jena ( Site 0903)
Jena, Thuringia, Germany, 07747
Actively Recruiting
58
Henry Dunant Hospital ( Site 1005)
Athens, Attica, Greece, 115 26
Actively Recruiting
59
Metropolitan General Hospital ( Site 1001)
Athens, Attica, Greece, 155 62
Actively Recruiting
60
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1000)
Chaidari/Athens, Attica, Greece, 124 62
Actively Recruiting
61
European Interbalkan Medical Center-Oncology Department ( Site 1008)
Thessaloniki, Greece, 570 01
Actively Recruiting
62
Szegedi Tudomanyegyetem ( Site 1113)
Szeged, Csongrád megye, Hungary, 6725
Actively Recruiting
63
Gyor- Moson- Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz ( Site 1116)
Győr, Győr-Moson-Sopron, Hungary, 9024
Actively Recruiting
64
Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 1118)
Eger, Heves County, Hungary, 3300
Actively Recruiting
65
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaza ( Site 1117)
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400
Actively Recruiting
66
Debreceni Egyetem Klinikai Kozpont ( Site 1112)
Debrecen, Hungary, 4032
Actively Recruiting
67
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1202)
Milan, Lombardy, Italy, 20133
Actively Recruiting
68
Istituto Nazionale Tumori Regina Elena ( Site 1201)
Rome, Roma, Italy, 00128
Actively Recruiting
69
Azienda USL 8 di Arezzo ( Site 1203)
Arezzo, Italy, 52100
Actively Recruiting
70
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1200)
Roma, Italy, 00168
Actively Recruiting
71
Rijnstate ( Site 1307)
Arnhem, Gelderland, Netherlands, 6815 AD
Actively Recruiting
72
Erasmus MC ( Site 1300)
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
73
Oncosalud ( Site 0701)
Lima, Lima Province, Peru, 15036
Actively Recruiting
74
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0702)
San Isidro, Lima region, Peru, 15038
Actively Recruiting
75
Hospital Militar Central Luis Arias Schereiber ( Site 0700)
Lima, Peru, 15076
Actively Recruiting
76
Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k ( Site 1402)
Poznan, Greater Poland Voivodeship, Poland, 61-731
Actively Recruiting
77
Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 1404)
Tarnów, Lesser Poland Voivodeship, Poland, 33-100
Actively Recruiting
78
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Moczowego ( Site 1401)
Warszawa, Lesser Poland Voivodeship, Poland, 02-781
Completed
79
Hospital Universitari Parc Tauli ( Site 1505)
Sabadell, Barcelona, Spain, 08208
Actively Recruiting
80
Hospital Insular de Gran Canaria ( Site 1502)
Las Palmas de Gran Canaria, Canary Islands, Spain, 35016
Actively Recruiting
81
Hospital Clinico San Carlos... ( Site 1500)
Madrid, Spain, 28040
Actively Recruiting
82
Hospital Universitario 12 de Octubre ( Site 1507)
Madrid, Spain, 28041
Actively Recruiting
83
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1506)
Madrid, Spain, 28223
Actively Recruiting
84
Hospital Universitario Virgen Macarena ( Site 1504)
Seville, Spain, 41009
Actively Recruiting
85
Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 3002)
Dusit, Bangkok, Thailand, 10300
Actively Recruiting
86
Faculty of Medicine - Khon Kaen University ( Site 3001)
Muang, Changwat Khon Kaen, Thailand, 40002
Actively Recruiting
87
Gartnavel General Hospital ( Site 1702)
Glasgow, Glasgow City, United Kingdom, G12 0YN
Actively Recruiting
88
St Bartholomew s Hospital ( Site 1700)
London, London, City of, United Kingdom, EC1A 7BE
Actively Recruiting
89
Torbay Hospital ( Site 1701)
Torquay, United Kingdom, TQ2 7AA
Actively Recruiting
Research Team
T
Toll Free Number
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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