Clinical Trials List
Protocol NumberMK-1045-007
NCT Number(ClinicalTrials.gov Identfier)NCT07634471
Not yet recruiting
2026-04-20 - 2034-12-31
Phase II/III
Not yet recruiting2
A Phase 2/3 randomized, open-label study of MK-1045 in combination with rituximab in participants with 1L follicular lymphoma
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Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
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Sponsor
MERCK SHARP & DOHME (I.A.) LLC. TAIWAN BRANCH (U.S.A.)
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Trial scale
Multi-Regional Multi-Center
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Update
2026/09/14
Investigators and Locations
Co-Principal Investigator
- 田豐銘 Division of General Internal Medicine
- Huai-Hsuan Huang Division of General Internal Medicine
- Chien-Chin Lin Division of Others -
- HSIN-AN HOU Division of General Internal Medicine
- Wen-Chien Chou Division of General Internal Medicine
- CHENG-HONG TSAI Division of General Internal Medicine
- Tai-Chung Huang Division of General Internal Medicine
- Chieh-Lung Cheng Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Principal Investigator
HSUAN JEN SHIH
Co-Principal Investigator
- 陳寧君 Division of Hematology & Oncology
- 莊覲瑄 Division of Hematology & Oncology
- 詹筑伊 Division of Hematology & Oncology
- Hung Chang Division of Hematology & Oncology
- 王元欽 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Follicular Lymphoma
Objectives
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)
Test Drug
MK-1045
Rituximab
Rituximab
Active Ingredient
MK-1045
Rituximab
Rituximab
Dosage Form
Injection
Injection
Injection
Dosage
5mg/vial
500mg/vial
500mg/vial
Endpoints
Part 1: Number of Participants Who Experience an Adverse Event (AE) An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Up to approximately 15 months
Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Up to approximately 12 months
Part 1: Number of Participants Who Experience Dose Limiting Toxicity (DLT) DLT will be defined as any drug-related AE observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle. Up to approximately 36 days
Part 1: Complete Response (CR) Rate For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) per Lugano response criteria. CR rate is defined as the percentage of participants who experience a CR. The CR rate as assessed by physician investigator will be presented. Up to approximately 60 months
Part 2: Progression-Free Survival (PFS) PFS is defined as the time from randomization to the first documented disease progression per Lugano response criteria by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first. Up to approximately 63 months
Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Up to approximately 12 months
Part 1: Number of Participants Who Experience Dose Limiting Toxicity (DLT) DLT will be defined as any drug-related AE observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle. Up to approximately 36 days
Part 1: Complete Response (CR) Rate For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) per Lugano response criteria. CR rate is defined as the percentage of participants who experience a CR. The CR rate as assessed by physician investigator will be presented. Up to approximately 60 months
Part 2: Progression-Free Survival (PFS) PFS is defined as the time from randomization to the first documented disease progression per Lugano response criteria by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first. Up to approximately 63 months
Inclution 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.
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.
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.
The Estimated Number of Participants
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Taiwan
4 participants
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Global
960 participants
