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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-517335-46-00 | Registry Identifier | EU CT | |
| U1111-1312-0572 | Registry Identifier | UTN | |
| INTerpath-011 | Other Identifier | MSD | |
| V940-011 | Other Identifier | MSD |
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| Name | Class |
|---|---|
| ModernaTX, Inc. | INDUSTRY |
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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 goal of this study are to learn if people who receive V940 with BCG live longer and without the cancer growing, spreading, or coming back compared to people who receive BCG alone.
As of Amendment 03 (effective 01/05/2026), outcome measures associated with the Intismeran autogene Monotherapy Arm (Cohort B) are no longer considered primary or secondary outcome measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intismeran autogene + BCG | Experimental | Participants in Cohort A 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. |
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| BCG | Active Comparator | Participants in Cohort A 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 |
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| Intismeran autogene | Experimental | Participants in Cohort B receive 1 mg of intismeran autogene via intramuscular (IM) injection every 3 weeks (Q3W) for 9 doses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intismeran autogene | Biological | IM injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Cohort A: Event-free Survival (EFS) | EFS is defined as the time from randomization to any of the following events, as determined by blinded independent central review (BICR): High-grade (HG) non-invasive papillary carcinoma (Ta) or carcinoma in situ (CIS) in the bladder at the 24-week assessment or later; Any T1 stage disease in the bladder; Any T2 stage or greater in the bladder, including transurethral prostate stromal invasion of urothelial carcinoma (UC); High-risk disease (defined as HG Ta, CIS, ≥T1) of the urethra or upper tract (ureters, renal pelvis); Metastatic UC [defined as regional lymph node metastasis of UC (stage N1 or greater), or distant metastasis of UC including non-regional lymph nodes (stage M1)]; Or death due to any cause. The EFS for BCG-treated participants will be presented. | Up to approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort A: 12-Month Event-free Survival (EFS) | EFS is defined as the time from randomization to any of the following events, as determined by BICR where applicable: HG Ta or CIS in the bladder at the 24-week assessment or later; Any T1 stage disease in the bladder; Any T2 stage or greater in the bladder, including transurethral prostate stromal invasion of UC; High-risk disease (defined as HG Ta, CIS, ≥T1) of the urethra or upper tract (ureters, renal pelvis); Metastatic UC [defined as regional lymph node metastasis of UC (stage N1 or greater), or distant lymph node or visceral metastasis of UC (stage M1)]; Or death due to any cause. The EFS at 12 months for BCG-treated participants will be presented. |
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Inclusion Criteria:
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
Cohort A:
Cohort B:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Cohort A:
Cohort B:
- HIV-infected individuals with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael G Oefelein Clinical Trials ( Site 0138) | Recruiting | Bakersfield | California | 93301 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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Participants allocated to receive BCG will be randomized 1:1 to the intismeran autogene+BCG arm and the BCG arm (Cohort A).
Participants allocated to receive intismeran autogene monotherapy will be allocated to the single intismeran autogene monotherapy arm (Cohort B).
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| BCG | Biological | Intravesicular instillation. BCG is a preparation of Bacillus Calmette-Guerin. |
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| Up to approximately 12 months |
| Cohort A: 24-Month Event-free Survival (EFS) | EFS is defined as the time from randomization to any of the following events, as determined by BICR where applicable: HG Ta or CIS in the bladder at the 24-week assessment or later; Any T1 stage disease in the bladder; Any T2 stage or greater in the bladder, including transurethral prostate stromal invasion of UC; High-risk disease (defined as HG Ta, CIS, ≥T1) of the urethra or upper tract (ureters, renal pelvis); Metastatic UC [defined as regional lymph node metastasis of UC (stage N1 or greater), or distant lymph node or visceral metastasis of UC (stage M1)]; Or death due to any cause. The EFS at 24 months for BCG-treated participants will be presented. | Up to approximately 24 months |
| Cohort A: Recurrence-free Survival (RFS) | RFS is defined as the time from randomization to any of the following events, as determined by BICR where applicable: HG Ta or CIS in the bladder at the 24-week assessment or later; Any T1 stage disease in the bladder; Any T2 stage or greater in the bladder, including transurethral prostate stromal invasion of UC; High-risk disease (defined as HG Ta, CIS, ≥T1) of the urethra or upper tract (ureters, renal pelvis); Metastatic UC [defined as regional lymph node metastasis of UC (stage N1 or greater), or distant lymph node or visceral metastasis of UC (stage M1)]; Death due to any cause; or any other UC recurrence including low-grade (LG) Ta at any timepoint as well as HG Ta or CIS in the bladder before the 24-week assessment. The RFS will be presented. | Up to approximately 5 years |
| Cohort A: Disease-specific Survival (DSS) | DSS is defined as the time from randomization to death due to bladder cancer. The DSS will be presented. | Up to approximately 5 years |
| Cohort A: Overall Survival (OS) | OS is defined as the time from randomization to death due to any cause. | Up to approximately 5 years |
| Cohort A: 12 Month Overall Survival Rate (OSR) | OSR is defined as the percentage of participants who are alive at 12 months. The 12 month OSR for BCG-treated participants will be presented. | Up to approximately 12 months |
| Cohort A: 24 Month Overall Survival Rate (OSR) | OSR is defined as the percentage of participants who are alive at 24 months. The 24 month OSR for BCG-treated participants will be presented. | Up to approximately 24 months |
| Cohort A: Complete Response Rate (CRR) | CRR is defined as the percentage of participants who achieve a Complete Response (CR) defined as the absence of all of the following as determined by BICR: High-risk non-muscle invasive UC (defined as HG Ta, CIS, or any T1 disease of the bladder, urethra, or upper tract [ureters, renal pelvis]); Any T2 or greater in the bladder, including transurethral prostate stromal invasion of UC; Metastatic UC [defined as regional lymph node metastasis of UC (N1 or greater), or distant metastasis of UC including non-regional lymph nodes (M1)]. The CRR for BCG-treated participants will be presented. | Up to approximately 5 years |
| Cohort A: Duration of Response (DOR) | For participants who achieve a Complete Response (CR: the absence of all of the following as determined by BICR using urine cytology, biopsy, and radiology assessments as applicable, and local cystoscopy evaluation: High-risk non-muscle invasive UC (defined as HG Ta, CIS, or any T1 UC in the bladder, urethra; Any T2 or greater UC in the bladder, including transurethral prostate stromal invasion of UC; Extravesical UC as defined in CR; Metastatic UC [defined as regional lymph node metastasis of UC (N1 or greater), or distant lymph node or visceral metastasis of UC (M1)]), DOR is defined as the time from first documented CR to the first occurrence of any of the following: High-risk non-muscle invasive UC; muscle-invasive bladder cancer (MIBC) or locally-advanced or metastatic UC; Or death due to any cause. DOR as assessed by BICR will be presented. | Up to approximately 5 years |
| Cohort A: Time to Cystectomy | Time to cystectomy, defined as the time from randomization to the date of radical cystectomy, will be presented for BCG-treated participants. | Up to approximately 5 years |
| Cohort A: Number of Participants Who Experience an Adverse Event (AE) | 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE in the study will be presented. | Up to approximately 21 months |
| Cohort A: Number of Participants Who Discontinue Study Intervention Due to an AE | 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue the study intervention due to an AE in the study will be presented. | Up to approximately 18 months |
| Genesis Research, LLC ( Site 0141) | Active, not recruiting | Los Alamitos | California | 90720 | United States |
| USC Norris Comprehensive Cancer Center ( Site 0123) | Recruiting | Los Angeles | California | 90033 | United States |
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| Genesis Healthcare-Torrance ( Site 0140) | Recruiting | Torrance | California | 90503 | United States |
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| Genesis Research LLC ( Site 0118) | Recruiting | Torrance | California | 90505 | United States |
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| Urology Associates ( Site 0144) | Recruiting | Littleton | Colorado | 80122 | United States |
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| Urological Research Network ( Site 0133) | Recruiting | Hialeah | Florida | 33016 | United States |
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| Associated Urological Specialists - Chicago Ridge ( Site 0139) | Recruiting | Chicago Ridge | Illinois | 60415 | United States |
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| Southern Urology, LLC ( Site 0145) | Recruiting | Lafayette | Louisiana | 70508 | United States |
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| University of Missouri Health Care ( Site 0126) | Recruiting | Columbia | Missouri | 65212 | United States |
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| NHO Revive Research Institute, LLC ( Site 0137) | Recruiting | Lincoln | Nebraska | 68506 | United States |
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| Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0111) | Recruiting | New York | New York | 10016 | United States |
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| TriState Urologic Services PSC Inc. dba The Urology Group ( Site 0122) | Recruiting | Cincinnati | Ohio | 45212 | United States |
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| OHSU Knight Cancer Institute - South Waterfront ( Site 0110) | Recruiting | Portland | Oregon | 97239 | United States |
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| MidLantic Urology ( Site 0102) | Recruiting | Bala-Cynwyd | Pennsylvania | 19004 | United States |
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| The Conrad Pearson Clinic ( Site 0143) | Recruiting | Germantown | Tennessee | 38138 | United States |
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| Texas Oncology-Austin Central ( Site 0107) | Recruiting | Austin | Texas | 78705 | United States |
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| Urology Austin, PLLC ( Site 0109) | Recruiting | Austin | Texas | 78759 | United States |
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| Urology of Virginia ( Site 0125) | Recruiting | Virginia Beach | Virginia | 23462 | United States |
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| University of Washington - Fred Hutchinson Cancer Center ( Site 0100) | Recruiting | Seattle | Washington | 98195 | United States |
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| Hospital Italiano de Buenos Aires ( Site 0307) | Recruiting | CABA | Buenos Aires | C1199ABD | Argentina |
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| Instituto Alexander Fleming ( Site 0306) | Recruiting | Ciudad Autónoma de Buenos Aires | Buenos Aires | C1426ANZ | Argentina |
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| Instituto de Investigaciones Clinicas Mar de Plata ( Site 0305) | Recruiting | Mar del Plata | Buenos Aires | B7600FZO | Argentina |
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| Asociación de Beneficencia Hospital Sirio Libanés ( Site 0303) | Recruiting | Buenos Aires | Buenos Aires F.D. | C1419AHN | Argentina |
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| Fundacion Estudios Clinicos ( Site 0304) | Recruiting | Rosario | Santa Fe Province | S2000DEJ | Argentina |
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| Sanatorio Parque ( Site 0300) | Recruiting | Rosario | Santa Fe Province | S2000DSV | Argentina |
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| Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0301) | Recruiting | La Rioja | F5300COE | Argentina |
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| Macquarie University ( Site 1801) | Recruiting | Macquarie University | New South Wales | 2109 | Australia |
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| Fiona Stanley Hospital ( Site 1803) | Recruiting | Perth | Western Australia | 6150 | Australia |
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| Instituto do Câncer e Transplante de Curitiba ( Site 0402) | Recruiting | Curitiba | Paraná | 80510-130 | Brazil |
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| Hospital de ClÃnicas de Passo Fundo ( Site 0406) | Recruiting | Passo Fundo | Rio Grande do Sul | 99010-260 | Brazil |
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| Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0400) | Recruiting | Barretos | São Paulo | 14784-400 | Brazil |
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| Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0410) | Recruiting | São Jose Do Rio Preto | São Paulo | 15090-000 | Brazil |
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| The Moncton Hospital-Oncology ( Site 0200) | Recruiting | Moncton | New Brunswick | E1C 6Z8 | Canada |
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| Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0204) | Recruiting | Sherbrooke | Quebec | J1H 5N4 | Canada |
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| Oncocentro Valdivia ( Site 0507) | Recruiting | Valdivia | Los RÃos Region | 5112129 | Chile |
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| FALP ( Site 0500) | Recruiting | Santiago | Region M. de Santiago | 7500921 | Chile |
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| Pontificia Universidad Catolica de Chile ( Site 0502) | Recruiting | Santiago | Region M. de Santiago | 8330032 | Chile |
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| Bradfordhill ( Site 0501) | Recruiting | Santiago | Region M. de Santiago | 8420383 | Chile |
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| ONCOCENTRO APYS ( Site 0505) | Recruiting | Viña del Mar | Valparaiso | 2520598 | Chile |
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| Bradford Hill Norte ( Site 0503) | Recruiting | Antofagasta | 1240000 | Chile |
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| Instituto de CancerologÃa ( Site 0600) | Recruiting | MedellÃn | Antioquia | 050021 | Colombia |
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| Clinica Colsanitas S.A, Sede ClÃnica Universitaria Colombia-Center Investigator ( Site 0603) | Recruiting | Bogotá | Bogota D.C. | 111321 | Colombia |
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| IMAT S.A.S ( Site 0601) | Recruiting | MonterÃa | Departamento de Córdoba | 230002 | Colombia |
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| Oncólogos del Occidente S.A.S. - Sede Pereira ( Site 0604) | Recruiting | Pereira | Risaralda Department | 661001 | Colombia |
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| ClÃnica Imbanaco S.A.S ( Site 0602) | Recruiting | Cali | Valle del Cauca Department | Colombia |
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| Herlev and Gentofte Hospital ( Site 3101) | Recruiting | Herlev | Capital Region | 2730 | Denmark |
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| CHU Dijon Bourgogne ( Site 0802) | Recruiting | Dijon | Cote-d Or | 21079 | France |
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| Bordeaux University Hospital - Pellegrin ( Site 0806) | Recruiting | Bordeaux | Gironde | 33076 | France |
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| CHU de Rouen- urology ( Site 0803) | Recruiting | Rouen | Haute-Normandie | 76031 | France |
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| Hôpital Foch-Urology department ( Site 0801) | Recruiting | Suresnes | Hauts-de-Seine | 92150 | France |
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| Hôpital Saint-Louis ( Site 0807) | Recruiting | Paris | Île-de-France Region | 75010 | France |
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| Klinikum Stuttgart - Katharinenhospital ( Site 0909) | Recruiting | Stuttgart | Baden-Wurttemberg | 70174 | Germany |
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| Klinikum der Universität München Großhadern ( Site 0910) | Recruiting | Munich | Bavaria | 81377 | Germany |
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| Marienhospital Herne ( Site 0907) | Recruiting | Herne | North Rhine-Westphalia | 44625 | Germany |
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| Universitaetsklinikum Halle ( Site 0902) | Recruiting | Halle | Saxony-Anhalt | 06120 | Germany |
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| Universitaetsklinikum Jena ( Site 0903) | Recruiting | Jena | Thuringia | 07747 | Germany |
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| Henry Dunant Hospital ( Site 1005) | Recruiting | Athens | Attica | 115 26 | Greece |
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| Metropolitan General Hospital ( Site 1001) | Recruiting | Athens | Attica | 155 62 | Greece |
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| ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1000) | Recruiting | Chaidari/Athens | Attica | 124 62 | Greece |
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| European Interbalkan Medical Center-Oncology Department ( Site 1008) | Recruiting | Thessaloniki | 570 01 | Greece |
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| Szegedi Tudomanyegyetem ( Site 1113) | Recruiting | Szeged | Csongrád megye | 6725 | Hungary |
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| Gyor- Moson- Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz ( Site 1116) | Recruiting | Győr | Győr-Moson-Sopron | 9024 | Hungary |
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| Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 1118) | Recruiting | Eger | Heves County | 3300 | Hungary |
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| Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaza ( Site 1117) | Recruiting | NyÃregyháza | Szabolcs-Szatmár-Bereg | 4400 | Hungary |
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| Debreceni Egyetem Klinikai Kozpont ( Site 1112) | Recruiting | Debrecen | 4032 | Hungary |
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| Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1202) | Recruiting | Milan | Lombardy | 20133 | Italy |
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| Istituto Nazionale Tumori Regina Elena ( Site 1201) | Recruiting | Rome | Roma | 00128 | Italy |
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| Azienda USL 8 di Arezzo ( Site 1203) | Recruiting | Arezzo | 52100 | Italy |
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| Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1200) | Recruiting | Roma | 00168 | Italy |
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| Rijnstate ( Site 1307) | Recruiting | Arnhem | Gelderland | 6815 AD | Netherlands |
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| Erasmus MC ( Site 1300) | Recruiting | Rotterdam | South Holland | 3015 GD | Netherlands |
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| Oncosalud ( Site 0701) | Recruiting | Lima | Lima Province | 15036 | Peru |
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| IPOR Instituto Peruano de OncologÃa & Radioterapia ( Site 0702) | Recruiting | San Isidro | Lima region | 15038 | Peru |
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| Hospital Militar Central Luis Arias Schereiber ( Site 0700) | Recruiting | Lima | 15076 | Peru |
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| Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k ( Site 1402) | Recruiting | Poznan | Greater Poland Voivodeship | 61-731 | Poland |
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| Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 1404) | Recruiting | Tarnów | Lesser Poland Voivodeship | 33-100 | Poland |
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| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Moczowego ( Site 1401) | Completed | Warszawa | Lesser Poland Voivodeship | 02-781 | Poland |
| Hospital Universitari Parc Tauli ( Site 1505) | Recruiting | Sabadell | Barcelona | 08208 | Spain |
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| Hospital Insular de Gran Canaria ( Site 1502) | Recruiting | Las Palmas de Gran Canaria | Canary Islands | 35016 | Spain |
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| Hospital Clinico San Carlos... ( Site 1500) | Recruiting | Madrid | 28040 | Spain |
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| Hospital Universitario 12 de Octubre ( Site 1507) | Recruiting | Madrid | 28041 | Spain |
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| HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 1506) | Recruiting | Madrid | 28223 | Spain |
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| Hospital Universitario Virgen Macarena ( Site 1504) | Recruiting | Seville | 41009 | Spain |
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| Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 3002) | Recruiting | Dusit | Bangkok | 10300 | Thailand |
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| Faculty of Medicine - Khon Kaen University ( Site 3001) | Recruiting | Muang | Changwat Khon Kaen | 40002 | Thailand |
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| Gartnavel General Hospital ( Site 1702) | Recruiting | Glasgow | Glasgow City | G12 0YN | United Kingdom |
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| St Bartholomew s Hospital ( Site 1700) | Recruiting | London | London, City of | EC1A 7BE | United Kingdom |
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| Torbay Hospital ( Site 1701) | Recruiting | Torquay | TQ2 7AA | United Kingdom |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D000093284 | Non-Muscle Invasive Bladder Neoplasms |
| D002278 | Carcinoma in Situ |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D001500 | BCG Vaccine |
| ID | Term |
|---|---|
| D032581 | Tuberculosis Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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