A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003)

Официальное название

Phase 1/2 Study of Intravesical MK-3120 in BCG-Naïve or BCG-Exposed High-Risk Non-muscle Invasive Bladder Cancer

Обзор

Researchers are looking for new ways to treat high-risk non-muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder and has not spread to the bladder muscle or outside of the bladder. In standard treatment for HR NMIBC, doctors first remove the tumor with a procedure called transurethral resection of the bladder tumor (TURBT). Researchers want to learn if using MK-3120, the study medicine, can treat HR NMIBC after TURBT. The goal of this study is to learn about the safety of MK-3120 and if people tolerate it.

Вмешательства

• Биопрепарат MK-3120
  Intravesical administration at one of three doses per protocol

Первичные конечные точки

• Number of Participants Who Experience a Dose-limiting Toxicity (DLT) [Срок оценки: Up to approximately 5 weeks]
• Number of Participants Who Experience One or More Adverse Events (AEs) [Срок оценки: Up to approximately 24 months]
• Number of Participants Who Discontinue Study Treatment Due to AEs [Срок оценки: Up to approximately 12 months]

Вторичные конечные точки (1)

• Complete Response Rate (CRR) [Срок оценки: Up to approximately 3 months]

Критерии участия

Критерии включения

• Has histologically confirmed carcinoma in situ (CIS) +/- papillary high-risk non-muscle invasive bladder cancer (NMIBC), confirmed locally.
• Is an individual whose most recent transurethral resection of bladder tumor (TURBT) was performed within 12 weeks before allocation and showed high-risk NMIBC histology. For individuals with papillary tumors (Ta and T1), a complete TURBT must have been performed, as characterized by attainment of a visually complete resection of all papillary tumors (Ta and T1).
• Is either: a) Bacillus Calmette-Guérin (BCG)-naïve, defined as either having never received BCG or having received BCG more than 2 years before CIS +/- papillary 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 OR; b) BCG-exposed and received adequate BCG therapy and had recurrence of CIS +/- papillary high-risk NMIBC >12 months but ≤24 months after the last BCG dose.
• Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy.
• Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation.
• Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.

Критерии исключения

• Has history of or current locally advanced (ie, T2, T3, T4) or metastatic urothelial cancer (UC).
• Has concurrent extravesical (ie, urethra, ureter, renal pelvis) non-muscle invasive UC or history of extravesical non-muscle invasive UC that recurred within the last 2 years.
• Has active total bladder incontinence, active urinary tract infection, neurogenic bladder, or urethral stricture.
• Has a condition that would prohibit normal voiding (or holding bladder voiding for 1 to 2 hours).
• Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to >470 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention.
• Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
• HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
• Has known additional malignancy that is progressing or has required active treatment within the past 3 years.
• Has known active central nervous system metastases and/or carcinomatous meningitis.
• Has active infection requiring systemic therapy.
• Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, or has current pneumonitis/ILD.
• Has not adequately recovered from major surgery or has ongoing surgical complications.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Michael G Oefelein Clinical Trials ( Site 0005) — Bakersfield
• Carolina Urologic Research Center ( Site 0006) — Myrtle Beach

Испания · 2 центра

• Hospital Universitario Virgen de la Victoria ( Site 0111) — Málaga
• Hospital Universitario 12 de Octubre ( Site 0112) — Madrid

Turkey (Türkiye) · 2 центра

• Ankara University Health Practice and Research Hospitals ( Site 0132) — Ankara
• Koc Universitesi Hastanesi ( Site 0133) — Istanbul

Австрия · 1 центр

• Medizinische Universität Wien ( Site 0021) — Vienna

Бельгия · 1 центр

• UZ Gent ( Site 0031) — Ghent

Канада · 1 центр

• CHU de Quebec - Hopital de l'Enfant-Jesus ( Site 0011) — Québec

Франция · 1 центр

• Gustave Roussy ( Site 0041) — Villejuif

Греция · 1 центр

• European Interbalkan Medical Center ( Site 0051) — Thessaloniki

Израиль · 1 центр

• Rabin Medical Center ( Site 0062) — Petah Tikva

Италия · 1 центр

• Centro Ricerche Cliniche di Verona ( Site 0072) — Verona

Нидерланды · 1 центр

• Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 0081) — Amsterdam

Норвегия · 1 центр

• Akershus Universitetssykehus ( Site 0091) — Lorenskog

Идентификаторы

NCT: NCT07222488 · 3120-003 · U1111-1317-2687 · 2025-520467-40-00 · MK-3120-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗