A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011)

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат Intismeran autogene
  IM injection
• Биопрепарат BCG
  Intravesicular instillation. BCG is a preparation of Bacillus Calmette-Guerin.

Первичные конечные точки

• Cohort A: Event-free Survival (EFS) [Срок оценки: Up to approximately 5 years]

Вторичные конечные точки (12)

• Cohort A: 12-Month Event-free Survival (EFS) [Срок оценки: Up to approximately 12 months]
• Cohort A: 24-Month Event-free Survival (EFS) [Срок оценки: Up to approximately 24 months]
• Cohort A: Recurrence-free Survival (RFS) [Срок оценки: Up to approximately 5 years]
• Cohort A: Disease-specific Survival (DSS) [Срок оценки: Up to approximately 5 years]
• Cohort A: Overall Survival (OS) [Срок оценки: Up to approximately 5 years]
• Cohort A: 12 Month Overall Survival Rate (OSR) [Срок оценки: Up to approximately 12 months]
• Cohort A: 24 Month Overall Survival Rate (OSR) [Срок оценки: Up to approximately 24 months]
• Cohort A: Complete Response Rate (CRR) [Срок оценки: Up to approximately 5 years]
• Cohort A: Duration of Response (DOR) [Срок оценки: Up to approximately 5 years]
• Cohort A: Time to Cystectomy [Срок оценки: Up to approximately 5 years]
• Cohort A: Number of Participants Who Experience an Adverse Event (AE) [Срок оценки: Up to approximately 21 months]
• Cohort A: Number of Participants Who Discontinue Study Intervention Due to an AE [Срок оценки: Up to approximately 18 months]

Критерии участия

Критерии включения

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:

• 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

Cohort B:

• 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)

Критерии исключения

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

• Has a history of or concurrent locally-advanced (ie, T2, T3, T4) or metastatic UC
• Has concurrent extravesical (ie, urethra, ureter, renal pelvis) non-muscle invasive UC or a history of extravesical non-muscle invasive UC that recurred within the last 2 years, with certain exceptions
• Has a known additional malignancy that is progressing or has required active treatment within the last 3 years
• Has had a myocardial infarction within 6 months of randomization/allocation
• Has received any systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation
• Has received prior treatment with a cancer vaccine
• Has immunodeficiency or is receiving chronic systemic steroid therapy
• Has active autoimmune disease that has required systemic treatment in the last 2 years
• Has any contraindication to IV contrast and gadolinium or is otherwise unable to have imaging with either computerized tomography urogram (CTU) or Magnetic resonance urography (MRU)

Cohort A:

• Has current active tuberculosis
• Has a known history of HIV infection

Cohort B:

\- HIV-infected individuals with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 20 центров

• Michael G Oefelein Clinical Trials ( Site 0138) — Bakersfield
• Genesis Research, LLC ( Site 0141) — Los Alamitos
• USC Norris Comprehensive Cancer Center ( Site 0123) — Los Angeles
• Genesis Healthcare-Torrance ( Site 0140) — Torrance
• Genesis Research LLC ( Site 0118) — Torrance
• Urology Associates ( Site 0144) — Littleton
• Urological Research Network ( Site 0133) — Hialeah
• Associated Urological Specialists - Chicago Ridge ( Site 0139) — Chicago Ridge
• … и ещё 12 центров

Аргентина · 7 центров

• Hospital Italiano de Buenos Aires ( Site 0307) — CABA
• Instituto Alexander Fleming ( Site 0306) — Ciudad Autónoma de Buenos Aires
• Instituto de Investigaciones Clinicas Mar de Plata ( Site 0305) — Mar del Plata
• Asociación de Beneficencia Hospital Sirio Libanés ( Site 0303) — Buenos Aires
• Fundacion Estudios Clinicos ( Site 0304) — Rosario
• Sanatorio Parque ( Site 0300) — Rosario
• Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0301) — La Rioja

Чили · 6 центров

• Oncocentro Valdivia ( Site 0507) — Valdivia
• FALP ( Site 0500) — Santiago
• Pontificia Universidad Catolica de Chile ( Site 0502) — Santiago
• Bradfordhill ( Site 0501) — Santiago
• ONCOCENTRO APYS ( Site 0505) — Viña del Mar
• Bradford Hill Norte ( Site 0503) — Antofagasta

Испания · 6 центров

• Hospital Universitari Parc Tauli ( Site 1505) — Sabadell
• Hospital Insular de Gran Canaria ( Site 1502) — Las Palmas de Gran Canaria
• … и ещё 4 центра

Колумбия · 5 центров

• Instituto de Cancerología ( Site 0600) — Medellín
• Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 060 — Bogotá
• IMAT S.A.S ( Site 0601) — Montería
• Oncólogos del Occidente S.A.S. - Sede Pereira ( Site 0604) — Pereira
• Clínica Imbanaco S.A.S ( Site 0602) — Cali

Франция · 5 центров

• CHU Dijon Bourgogne ( Site 0802) — Dijon
• Bordeaux University Hospital - Pellegrin ( Site 0806) — Bordeaux
• CHU de Rouen- urology ( Site 0803) — Rouen
• Hôpital Foch-Urology department ( Site 0801) — Suresnes
• Hôpital Saint-Louis ( Site 0807) — Paris

Германия · 5 центров

• Klinikum Stuttgart - Katharinenhospital ( Site 0909) — Stuttgart
• Klinikum der Universität München Großhadern ( Site 0910) — Munich
• Marienhospital Herne ( Site 0907) — Herne
• Universitaetsklinikum Halle ( Site 0902) — Halle
• Universitaetsklinikum Jena ( Site 0903) — Jena

Венгрия · 5 центров

• Szegedi Tudomanyegyetem ( Site 1113) — Szeged
• Gyor- Moson- Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz ( Site 1116) — Győr
• Heves Vármegyei Markhot Ferenc Oktatókórház és Rendelőintézet ( Site 1118) — Eger
• Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaza ( Site 11 — Nyíregyháza
• Debreceni Egyetem Klinikai Kozpont ( Site 1112) — Debrecen

Бразилия · 4 центра

• Instituto do Câncer e Transplante de Curitiba ( Site 0402) — Curitiba
• Hospital de Clínicas de Passo Fundo ( Site 0406) — Passo Fundo
• Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0400) — Barretos
• Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0410) — São Jose Do Rio Preto

Греция · 4 центра

• Henry Dunant Hospital ( Site 1005) — Athens
• Metropolitan General Hospital ( Site 1001) — Athens
• ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1000) — Chaidari/Athens
• European Interbalkan Medical Center-Oncology Department ( Site 1008) — Thessaloniki

Италия · 4 центра

• Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1202) — Milan
• Istituto Nazionale Tumori Regina Elena ( Site 1201) — Rome
• Azienda USL 8 di Arezzo ( Site 1203) — Arezzo
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sac — Roma

Перу · 3 центра

• Oncosalud ( Site 0701) — Lima
• IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0702) — San Isidro
• Hospital Militar Central Luis Arias Schereiber ( Site 0700) — Lima

Польша · 3 центра

• Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k ( Site 1402) — Poznan
• Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 1404) — Tarnów
• Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Moc — Warszawa

Великобритания · 3 центра

Список центров уточняется — проверьте первичный протокол.

Австралия · 2 центра

• Macquarie University ( Site 1801) — Macquarie University
• Fiona Stanley Hospital ( Site 1803) — Perth

Канада · 2 центра

• The Moncton Hospital-Oncology ( Site 0200) — Moncton
• Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospital — Sherbrooke

Нидерланды · 2 центра

• Rijnstate ( Site 1307) — Arnhem
• Erasmus MC ( Site 1300) — Rotterdam

Таиланд · 2 центра

Список центров уточняется — проверьте первичный протокол.

Дания · 1 центр

• Herlev and Gentofte Hospital ( Site 3101) — Herlev

Идентификаторы

NCT: NCT06833073 · V940-011 · 2024-517335-46-00 · U1111-1312-0572 · INTerpath-011 · V940-011

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗