A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)

Официальное название

A Phase 2/3 Randomized, Open-label Study of MK-1045 in Combination With Rituximab in Participants With 1L Follicular Lymphoma

Обзор

Researchers are looking for new ways to treat follicular lymphoma (FL). A standard (usual) treatment for FL includes a targeted therapy called rituximab and chemotherapy. In this study, researchers want to learn if giving a study medicine called MK-1045 and rituximab can treat FL. MK-1045 is a type of treatment called immunotherapy. The goals of this study are to learn: * About the safety of MK-1045 and rituximab, and if people tolerate them when given together * If people who receive MK-1045 and rituximab have the cancer go away * If people who receive MK-1045 and rituximab live longer without their cancer getting worse compared to those who receive standard treatment (rituximab and chemotherapy)

Вмешательства

• Биопрепарат MK-1045
  Intravenous (IV) infusion
• Биопрепарат Rituximab
  IV infusion
• Биопрепарат Rituximab biosimilar
  IV infusion
• Препарат Bendamustine
  IV infusion
• Препарат Cyclophosphamide
  IV infusion
• Препарат Vincristine
  IV infusion
• Препарат Prednisone
  Per approved product label
• Препарат Prednisolone
  Per approved product label
• Препарат Doxorubicin Hydrochloride
  IV infusion

Первичные конечные точки

• Part 1: Number of Participants Who Experience an Adverse Event (AE) [Срок оценки: Up to approximately 15 months]
• Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE [Срок оценки: Up to approximately 12 months]
• Part 1: Number of Participants Who Experience Dose Limiting Toxicity (DLT) [Срок оценки: Up to approximately 36 days]
• Part 1: Complete Response (CR) Rate [Срок оценки: Up to approximately 60 months]
• Part 2: Progression-Free Survival (PFS) [Срок оценки: Up to approximately 63 months]

Вторичные конечные точки (12)

• Part 1: Objective Response Rate (ORR) [Срок оценки: Up to approximately 60 months]
• Part 1: Duration of CR [Срок оценки: Up to approximately 60 months]
• Part 1: Area Under the Concentration-Time Curve at Steady State (AUCss) of MK-1045 [Срок оценки: Predose and at designated time points post-dose (up to approximately 12 months)]
• Part 1: Maximum Concentration (Cmax) of MK-1045 [Срок оценки: Predose and at designated time points post-dose (up to approximately 12 months)]
• Part 1: Trough Concentration (Ctrough) of MK-1045 [Срок оценки: Predose and at designated time points post-dose (up to approximately 12 months)]
• Part 2: CR Rate at 30 Months [Срок оценки: 30 months]
• Part 2: ORR [Срок оценки: Up to approximately 63 months]
• Part 2: Overall Survival (OS) [Срок оценки: Up to approximately 63 months]
• Part 2: Event-Free Survival (EFS) [Срок оценки: Up to approximately 63 months]
• Part 2: Duration of CR [Срок оценки: Up to approximately 63 months]
• Part 2: Number of Participants Who Experience an AE [Срок оценки: Up to approximately 15 months]
• Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE [Срок оценки: Up to approximately 12 months]

Критерии участия

Критерии включения

• Has biopsy-proven, previously untreated, histologically confirmed cluster of differentiation (CD)19-positive and CD20-positive classical follicular lymphoma (FL), with Ann Arbor Stage II-IV disease and a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2-5.
• Has radiographically measurable disease per the Lugano Response Criteria.
• Has provided a newly obtained core or excisional biopsy or archival tissue of a tumor lesion not previously irradiated.
• If human immunodeficiency virus (HIV)-positive, has well-controlled HIV on antiretroviral therapy (ART).
• If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy for at least 4 weeks and will continue it.
• If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.

Критерии исключения

• Has received prior systemic anticancer therapy or radiotherapy for FL.
• Has follicular large B-cell lymphoma or any other subtype of FL other than classical FL.
• Has FL that has transformed into a more aggressive type of lymphoma.
• History or presence of clinically relevant central nervous system (CNS) diseases.
• Has history of serious cardiovascular and cerebrovascular diseases.
• Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
• Has known active CNS lymphoma or involvement.
• Has an active autoimmune disease that has required systemic treatment in the past 2 years.
• Has active infection requiring systemic therapy.
• Has chronic liver disease, including liver cirrhosis of Child-Pugh class B or C.
• 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

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 5 центров

• Institut Català d'Oncologia (ICO) - Badalona ( Site 0904) — Badalona
• Hospital Virgen de la Victoria ( Site 0905) — Málaga
• Hospital Universitari Vall de Hebron ( Site 0903) — Barcelona
• Hospital Universitario Gregorio Maranon ( Site 0902) — Madrid
• Hospital Universitario de Salamanca ( Site 0906) — Salamanca

Израиль · 3 центра

• Hadassah Medical Center ( Site 0701) — Jerusalem
• Sheba Medical Center ( Site 0702) — Ramat Gan
• Sourasky Medical Center ( Site 0704) — Tel Aviv

Turkey (Türkiye) · 3 центра

• Hacettepe Universite Hastaneleri ( Site 1110) — Ankara
• Sisli Florence Nightingale Hastanesi ( Site 1112) — Istanbul
• Ondokuz Mayıs Universitesi ( Site 1113) — Samsun

США · 2 центра

• Duke Cancer Center Clinic 1B/C Onc/Heme ( Site 1307) — Durham
• SCRI Oncology Partners ( Site 7000) — Nashville

Тайвань · 2 центра

• National Taiwan University Hospital ( Site 1001) — Taipei
• Chang Gung Medical Foundation-Linkou Branch ( Site 1002) — Taoyuan

Аргентина · 1 центр

• Sanatorio Nuestra Senora del Rosario ( Site 0104) — Rosario

Идентификаторы

NCT: NCT07634471 · 1045-007 · U1111-1324-3019 · 2025-522777-10-00 · MK-1045-007

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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