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A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008)
NCT07519772 · Merck Sharp & Dohme LLC
In plain English
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Official title
A Phase 1b/2 Study to Evaluate the Safety and Efficacy of MK-1045 Monotherapy or in Combination With Other Anticancer Agents in Participants With Non-Hodgkin Lymphoma
About this study
Researchers are looking for new ways to treat 2 types of non-Hodgkin lymphoma (NHL) called follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). FL is a slow-growing type of NHL. DLBCL is a fast-growing type of NHL. NHL is a cancer in the lymphatic system that causes swollen lymph nodes. The lymphatic system is part of the immune system.
In this study, researchers want to learn if MK-1045 can treat FL and DLBCL. MK-1045 is a study treatment that is an immunotherapy, which helps the immune system fight cancer.
The goals of this study are to learn how safe MK-1045 is and if people tolerate it. Researchers also want to see if FL and DLBCL respond (the cancer gets smaller or goes away) to treatment.
Eligibility criteria
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Has disease that has relapsed (disease progression after remission) or is refractory (failure to achieve complete or partial response) to at least 2 prior systemic lines of therapy.
* Has a histologically confirmed diagnosis of follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL).
* DLBCL participants only: has progressed after or is ineligible for transplant and chimeric antigen receptor T (cell) (CAR-T) therapy.
* Has provided tumor tissue sample (archival or newly obtained, if performed per standard of care).
* Has documented retained expression of cluster of differentiation 19 (CD19) in tumor tissue obtained by biopsy after disease progression on CD19-targeting therapy, if experienced disease progression after prior CD19-targeting therapy.
* Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if has a history of HIV infection.
* Has undetectable hepatitis B virus (HBV) viral load and received and will continue to receive HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive.
* Has undetectable hepatitis C virus (HCV) viral load and received HCV antiviral therapy if has a history of HCV infection.
* Has radiographically measurable disease per Lugano Response Criteria.
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Has received a solid organ transplant.
* Had or has clinically relevant central nervous system (CNS) diseases.
* Has a history of serious cardiovascular or cerebrovascular diseases.
* Had prior allogenic stem cell transplantation with acute graft-versus-host-disease (GVHD); has ongoing evidence of chronic GVHD manifesting as skin involvement, diarrhea, or increased serum bilirubin; or requires systemic immunosuppression for GVHD.
* 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 of randomization.
* Has received prior CAR-T therapy within 3 months before the first dose of the study intervention.
* Has a known additional malignancy that is progressing or required active treatment within the past 2 years.
* Has known active CNS lymphoma or involvement.
* Has active autoimmune disease that required systemic treatment in the past 2 years.
* Has active infection requiring systemic therapy.
* Has a history of severe bleeding disorders.
* Has not recovered from major surgery or has ongoing surgical complications.
* Has diagnosis of primary mediastinal B-cell lymphoma.
Study design
Enrollment target: 280 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-05-03
Estimated completion: 2031-04-01
Last updated: 2026-09-11
Interventions
Biological: MK-1045
Primary outcomes
- • Number of Participants Who Experience an Adverse Event (AE) (Up to approximately 49 months)
- • Number of Participants Who Discontinue Study Treatment Due to an AE (Up to approximately 12 months)
- • Arms 2 and 3: Number of Participants Who Experience Dose Limiting Toxicity (DLT) (Up to approximately 28 days)
Sponsor
Merck Sharp & Dohme LLC · industry
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (39)
Colorado Blood Cancer Institute ( Site 7000)Recruiting
Denver, Colorado, United States
SCRI Oncology Partners ( Site 0100)Recruiting
Nashville, Tennessee, United States
Instituto Alexander Fleming ( Site 1404)Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Hospital Universitario Austral ( Site 1402)Recruiting
Pilar, Buenos Aires, Argentina
Sanatorio Nuestra Senora del Rosario ( Site 1403)Recruiting
Rosario, Santa Fe Province, Argentina
Townsville University Hospital ( Site 0204)Recruiting
Townsville, Queensland, Australia
Box Hill Hospital ( Site 0202)Recruiting
Box Hill, Victoria, Australia
Princess Margaret Cancer Centre ( Site 0301)Recruiting
Toronto, Ontario, Canada
Clínica Alemana de Santiago ( Site 1608)Recruiting
Santiago, Region M. de Santiago, Chile
Beijing Cancer hospital ( Site 1701)Recruiting
Beijing, Beijing Municipality, China
Sun Yat-Sen University Cancer Center ( Site 1712)Recruiting
Guangzhou, Guangdong, China
Fudan University Shanghai Cancer Center ( Site 1711)Recruiting
Shanghai, Shanghai Municipality, China
UKGM Gießen/Marburg ( Site 0505)Recruiting
Giessen, Hesse, Germany
Carmel Hospital ( Site 0602)Recruiting
Haifa, Israel
Shaare Zedek Medical Center ( Site 0603)Recruiting
Jerusalem, Israel
Haddasah Medical Center ( Site 0600)Recruiting
Jerusalem, Israel
Sheba Medical Center ( Site 0601)Recruiting
Ramat Gan, Israel
Sourasky Medical Center. ( Site 0604)Recruiting
Tel Aviv, Israel
Istituto Nazionale Tumori IRCCS Fondazione Pascale-SC Ematologia Oncologica ( Site 0700)Recruiting
Campania, Napoli, Italy
INOC - Istituto Nazionale Oncologico Candiolo ( Site 0701)Recruiting
Candiolo, Piedmont, Italy
Istituto Europeo di Oncologia IRCCS ( Site 0702)Recruiting
Milan, Italy
Fondazione Policlinico Universitario Agostino Gemelli ( Site 0705)Recruiting
Roma, Italy
Pratia MCM Krakow ( Site 0903)Recruiting
Krakow, Lesser Poland Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( Site 0900)Recruiting
Warsaw, Masovian Voivodeship, Poland
Pratia Onkologia Katowice ( Site 0902)Recruiting
Katowice, Silesian Voivodeship, Poland
Seoul National University Hospital ( Site 0800)Recruiting
Seoul, South Korea
The Catholic University of Korea, Yeouido St. Mary's Hospital ( Site 0801)Recruiting
Seoul, South Korea
Institut Català d'Oncologia (ICO) - Badalona ( Site 1103)Recruiting
Badalona, Barcelona, Spain
Hospital Virgen de la Victoria ( Site 1104)Recruiting
Málaga, Malaga, Spain
Hospital Universitari Vall de Hebron ( Site 1102)Recruiting
Barcelona, Spain
Hospital Universitario Gregorio Maranon ( Site 1101)Recruiting
Madrid, Spain
Hospital Universitario 12 de Octubre ( Site 1105)Recruiting
Madrid, Spain
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1000)Recruiting
Ankara, Turkey (Türkiye)
Antalya Egitim ve Arastirma Hastanesi ( Site 1003)Recruiting
Antalya, Turkey (Türkiye)
Koç Üniversitesi Hastanesi ( Site 1001)Recruiting
Istanbul, Turkey (Türkiye)
Medipol Mega Universite Hastanesi ( Site 1002)Recruiting
Istanbul, Turkey (Türkiye)
Samsun Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi ( Site 1005)Recruiting
Samsun, Turkey (Türkiye)
Derriford Hospital ( Site 1304)Recruiting
Plymouth, Devon, United Kingdom
The Christie NHS Foundation Trust ( Site 1300)Recruiting
Manchester, United Kingdom