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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1324-3019 | Registry Identifier | UTN | |
| 2025-522777-10-00 | Registry Identifier | EU CT | |
| MK-1045-007 | Other Identifier | MSD |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: MK-1045 plus Rituximab (or biosimilar) | Experimental | Participants will receive escalating doses of MK-1045 (from 2 mg to 90 mg) once weekly (QW) for up to approximately 12 months. Participants will also receive 375 mg/m^2 rituximab (or biosimilar) once every 4 weeks (Q4W) for up to approximately 6 months. |
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| Part 2: MK-1045 plus Rituximab (or biosimilar) | Experimental | Participants will receive MK-1045 QW at the dose determined in Part 1 for up to approximately 12 months. Participants will also receive 375 mg/m^2 rituximab (or biosimilar) Q4W for up to approximately 6 months. |
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| Part 2: Physician's Choice of Chemotherapy plus Rituximab (or biosimilar) | Experimental | Participants will receive physician's choice of: 90 mg/m^2 bendamustine on Days 1 and 2 of each 4-week cycle for up to 6 cycles (up to approximately 6 months) plus 375 mg/m^2 rituximab (or biosimilar) Q4W for up to approximately 6 months OR 750 mg/m^2 cyclophosphamide, 50 mg/m^2 doxorubicin, and 1.4 mg/m^2 vincristine on day 1 of each 3-week cycle (Q3W) and 100 mg/m^2 prednisone (or prednisolone) once daily on days 1 through 5 Q3W for up to 6 cycles (up to approximately 4 months) plus 375 mg/m^2 rituximab (or biosimilar) Q3W for up to approximately 4 months OR 750 mg/m^2 cyclophosphamide and 1.4 mg/m^2 vincristine Q3W and 40 mg/day prednisone (or prednisolone) once daily on days 1 through 5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 375 mg/m^2 rituximab (or biosimilar) Q3W for up to approximately 6 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-1045 | Biological | Intravenous (IV) infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Objective Response Rate (ORR) | ORR is defined as the percentage of participants with CR (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Lugano response criteria. The percentage of participants who experience CR or PR as assessed by physician investigator will be presented. | Up to approximately 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SCRI Oncology Partners ( Site 7000) | Recruiting | Nashville | Tennessee | 37203 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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| Rituximab | Biological | IV infusion |
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| Rituximab biosimilar | Biological | IV infusion |
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| Bendamustine | Drug | IV infusion |
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| Cyclophosphamide | Drug | IV infusion |
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| Vincristine | Drug | IV infusion |
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| Prednisone | Drug | Per approved product label |
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| Prednisolone | Drug | Per approved product label |
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| Doxorubicin Hydrochloride | Drug | IV infusion |
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| Part 1: Duration of CR | For participants who demonstrate CR (CR: disappearance of all target lesions) at end of treatment per Lugano response criteria, defined as the time from the first documented evidence of CR until disease progression or death due to any cause, whichever occurs first. | Up to approximately 60 months |
| Part 1: Area Under the Concentration-Time Curve at Steady State (AUCss) of MK-1045 | Blood samples will be collected at multiple time points to estimate the AUCss of MK-1045. | Predose and at designated time points post-dose (up to approximately 12 months) |
| Part 1: Maximum Concentration (Cmax) of MK-1045 | Blood samples will be collected at multiple time points to estimate the Cmax of MK-1045. | Predose and at designated time points post-dose (up to approximately 12 months) |
| Part 1: Trough Concentration (Ctrough) of MK-1045 | Blood samples will be collected at multiple time points to estimate the Ctrough of MK-1045. | Predose and at designated time points post-dose (up to approximately 12 months) |
| Part 2: CR Rate at 30 Months | For participants who demonstrate a confirmed CR (CR: disappearance of all target lesions) per Lugano response criteria. CR rate is defined as the percentage of participants who experience a CR by month 30. The CR rate as assessed by BICR at month 30 will be presented. | 30 months |
| Part 2: ORR | ORR is defined as the percentage of participants with CR (CR: disappearance of all target lesions) or PR (PR: at least a 30% decrease in the sum of diameters of target lesions) per Lugano response criteria. The percentage of participants who experience CR or PR as assessed by BICR will be presented. | Up to approximately 63 months |
| Part 2: Overall Survival (OS) | OS is defined as the time from randomization to death due to any cause. | Up to approximately 63 months |
| Part 2: Event-Free Survival (EFS) | EFS is defined as the time randomization to the first documented disease progression per Lugano response criteria by BICR, death due to any cause, initiation of a new anticancer therapy or a positive biopsy for residual disease, whichever occurs first. | Up to approximately 63 months |
| Part 2: Duration of CR | For participants who demonstrate CR (CR: disappearance of all target lesions) per Lugano response criteria by BICR, defined as the time from the first documented evidence of CR until disease progression or death due to any cause, whichever occurs first. | Up to approximately 63 months |
| Part 2: Number of Participants Who Experience 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 15 months |
| Part 2: 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 2: Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Trial Outcome Index (TOI) | The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients. Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S). The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60. FACT-G has 4 well-being domains, physical (7 items), social/family (7), emotional (6), and functional (7), with scores ranging from 0 to 108. FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116. FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168. The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. The higher the score the better the quality of life. | Baseline and up to approximately month 13 |
| Part 2: Change From Baseline in HRQoL on FACT-Lym Total Score | The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients. Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S). The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60. FACT-G has 4 well-being domains, physical (7 items), social/family (7), emotional (6), and functional (7), with scores ranging from 0 to 108. FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116. FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168. The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. The higher the score the better the quality of life. | Baseline and up to approximately month 13 |
| Part 2: Change From Baseline in HRQoL on FACT-Lym Physical Well-being (PWB) (Items General Physical [GP]1 Through GP7) | The FACT-Lym is a 42-item questionnaire designed to measure HRQoL and cancer-specific symptoms in non-Hodgkin lymphoma patients. Subscales include FACT-General (FACT-G), FACT-Trial Outcome Index (FACT-TOI), FACT-Lym total score (FACT-Lym TS), and the Lymphoma subscale (Lym S). The Lym S has a single domain consisting of 15 items specific to lymphoma burden with a score ranging from 0 to 60. FACT-G has 4 well-being domains, physical (7 items), social/family (7), emotional (6), and functional (7), with scores ranging from 0 to 108. FACT-TOI combines FACT-G's physical and functional domains with Lym S, with scores ranging from 0 to 116. FACT-Lym TS combines FACT-G with Lym S, with scores ranging from 0 to 168. The scoring of FACT-Lym is on a 5-point Likert scale from 0 to 4, with 0= not at all, 1= a little bit, 2= somewhat, 3=quite a bit, 4=very much. The higher the score the better the quality of life. | Baseline and up to approximately month 13 |
| Hadassah Medical Center ( Site 0701) | Recruiting | Jerusalem | 9112001 | Israel |
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| Sheba Medical Center ( Site 0702) | Recruiting | Ramat Gan | 5265601 | Israel |
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| Sourasky Medical Center ( Site 0704) | Recruiting | Tel Aviv | 6423906 | Israel |
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| Hospital Virgen de la Victoria ( Site 0905) | Recruiting | Málaga | Malaga | 29010 | Spain |
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| Hospital Universitari Vall de Hebron ( Site 0903) | Recruiting | Barcelona | 08035 | Spain |
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| Hospital Universitario Gregorio Maranon ( Site 0902) | Recruiting | Madrid | 28007 | Spain |
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| Chang Gung Medical Foundation-Linkou Branch ( Site 1002) | Recruiting | Taoyuan | 333 | Taiwan |
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| Hacettepe Universite Hastaneleri ( Site 1110) | Recruiting | Ankara | 06230 | Turkey (Türkiye) |
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| Sisli Florence Nightingale Hastanesi ( Site 1112) | Recruiting | Istanbul | 34381 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D000069461 | Bendamustine Hydrochloride |
| D003520 | Cyclophosphamide |
| D014750 | Vincristine |
| D011241 | Prednisone |
| D011239 | Prednisolone |
| C009935 | prednisolone acetate |
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010752 | Phosphoramide Mustards |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011246 | Pregnadienetriols |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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