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

Official title

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

Overview

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)

Interventions

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

Primary outcome measures

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

Secondary outcome measures (12)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Spain · 5 centers

• 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

Israel · 3 centers

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

Turkey (Türkiye) · 3 centers

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

United States · 2 centers

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

Taiwan · 2 centers

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

Argentina · 1 center

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

Identifiers

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

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗