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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1324-8720 | Registry Identifier | UTN | |
| 2025-523005-15-00 | Registry Identifier | EU CT |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Follicular Lymphoma (FL) MK-1045 Monotherapy Dose Optimization | Experimental | Participants will receive Dosage A of MK-1045 by Intravenous (IV) infusion for up to approximately 1 year of treatment or until discontinuation. |
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| Arm 2: FL MK-1045 Longer Dosing Interval | Experimental | Participants will receive Dosage B of MK-1045 by Intravenous (IV) infusion for up to approximately 1 year of treatment or until discontinuation. |
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| Arm 3: FL MK-1045 Subcutaneous Administration | Experimental | Participants will receive Dosage C of MK-1045 by subcutaneous (SC) injection for up to approximately 1 year of treatment or until discontinuation. |
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| Arm 4: Diffuse Large B-cell Lymphoma (DLBCL) MK-1045 Monotherapy Dose Optimization | Experimental | Participants will receive Dosage D of MK-1045 by Intravenous (IV) infusion for up to approximately 1 year of treatment or until discontinuation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-1045 | Biological | Intravenous (IV) Infusion or Subcutaneous (SC) injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported. | Up to approximately 44 months |
| Number of Participants Who Discontinue Study Treatment Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported. | Up to approximately 12 months |
| Arms 2 and 3: Number of Participants Who Experience Dose Limiting Toxicity (DLT) | DLT will be defined as any drug-related AE observed during the DLT evaluation period (up to 28 days) that results in a change to a given dose or a delay in initiating the next treatment. | Up to approximately 28 Days |
| Arms 1 and 4: Objective Response Rate (ORR) per Lugano Response Criteria as assessed by Blinded Independent Central review (BICR) | ORR is defined as the percentage of the participants who had complete response (CR) or partial response (PR) and will be evaluated using computed tomography (CT) and positron emission tomography (PET)-CT. Response will be assessed based on the International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). CR is complete metabolic (no/minimal fluorodeoxyglucose [FDG] uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). In Arms 1 and 4, the percentage of participants who experience CR or PR as assessed by BICR will be presented. |
| Measure | Description | Time Frame |
|---|---|---|
| Arms 1 and 4: Duration of Response (DOR) per Lugano Response Criteria as assessed by BICR | For participants who demonstrate a confirmed complete response (CR) or partial response (PR), DOR is defined as the time from CR or PR to documented disease progression or death. Participants are assessed using computed tomography (CT) and positron emission tomography (PET)-CT and response will be evaluated based on the Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). CR is complete metabolic (no/minimal fluorodeoxyglucose [FDG] uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters (SPD) for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). DOR as assessed by BICR will be presented for Arms 1 and 4. |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
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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 0100) | 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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| Up to approximately 44 months |
| Arm 2: ORR per Lugano Response Criteria as assessed by Investigator | ORR is defined as the percentage of the participants who had complete response (CR) or partial response (PR) and will be evaluated using computed tomography (CT) and positron emission tomography (PET)-CT. Response will be assessed based on the International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). CR is complete metabolic (no/minimal fluorodeoxyglucose [FDG] uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). In Arm 2, the percentage of participants who experience CR or PR as assessed by the Investigator will be presented. | Up to approximately 44 months |
| Up to approximately 44 months |
| Arms 2 and 3: DOR per Lugano Response Criteria as assessed by Investigator | For participants who demonstrate a confirmed complete response (CR) or partial response (PR), DOR is defined as the time from CR or PR to documented disease progression or death. Participants are assessed using computed tomography (CT) and positron emission tomography (PET)-CT and response will be evaluated based on the Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). CR is complete metabolic (no/minimal fluorodeoxyglucose [FDG] uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters (SPD) for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). DOR as assessed by the Investigator will be presented for Arms 2 and 3. | Up to approximately 44 months |
| Area Under the Concentration-time Curve Measured at Steady State (AUCss) of MK-1045 | Blood samples will be collected to determine the AUCss of MK-1045 in plasma. | Pre-dose and at designated time points post-dose up to 12 months |
| Trough Concentration (Ctrough) of MK-1045 | Blood samples will be collected to determine the Ctrough of MK-1045 in plasma. | Pre-dose and at designated time points post-dose up to 12 months |
| Maximum Serum Concentration (Cmax) of MK-1045 | Blood samples will be collected to determine the Cmax of MK-1045 in plasma. | Pre-dose and at designated time points post-dose up to 12 months |
| Arms 1, 2, and 4: Time to Maximum Serum Concentration (Tmax) of MK-1045 | Blood samples will be collected to determine the Tmax of MK-1045 in plasma. | Pre-dose and at designated time points post-dose up to 12 months |
| Arm 3: Absolute Bioavailability Expressed as a Percentage (F%) of MK-1045 | Blood samples will be collected to determine the F% of MK-1045 in plasma. | Pre-dose and at designated time points post-dose up to 12 months |
| Arm 3: ORR per Lugano Response Criteria as assessed by Investigator | ORR is defined as the percentage of the participants who had complete response (CR) or partial response (PR) and will be evaluated using computed tomography (CT) and positron emission tomography (PET)-CT. Response will be assessed based on the International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). CR is complete metabolic (no/minimal fluorodeoxyglucose [FDG] uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). In Arm 3, the percentage of participants who experience CR or PR as assessed by the Investigator will be presented. | Up to approximately 44 months |
| Instituto Alexander Fleming ( Site 1404) | Recruiting | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1426ANZ | Argentina |
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| Sanatorio Nuestra Senora del Rosario ( Site 1403) | Recruiting | Rosario | Santa Fe Province | 2001 | Argentina |
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| Beijing Cancer hospital ( Site 1701) | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| Shaare Zedek Medical Center ( Site 0603) | Recruiting | Jerusalem | 9103102 | Israel |
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| Haddasah Medical Center ( Site 0600) | Recruiting | Jerusalem | 9112001 | Israel |
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| Sheba Medical Center ( Site 0601) | Recruiting | Ramat Gan | 5265601 | Israel |
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| Sourasky Medical Center. ( Site 0604) | Recruiting | Tel Aviv | 6423906 | Israel |
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| Istituto di Candiolo - IRCCS ( Site 0701) | Recruiting | Candiolo | Piedmont | 10060 | Italy |
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| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( Site 0900) | Recruiting | Warsaw | Masovian Voivodeship | 02-781 | Poland |
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| Pratia Onkologia Katowice ( Site 0902) | Recruiting | Katowice | Silesian Voivodeship | 40-519 | Poland |
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| Hospital Universitari Vall de Hebron ( Site 1102) | Recruiting | Barcelona | 08035 | Spain |
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| Hospital Universitario Gregorio Maranon ( Site 1101) | Recruiting | Madrid | 28007 | Spain |
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| Hospital Universitario 12 de Octubre ( Site 1105) | Recruiting | Madrid | 28041 | Spain |
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| Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1000) | Recruiting | Ankara | 06230 | Turkey (Türkiye) |
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| Koç Üniversitesi Hastanesi ( Site 1001) | Recruiting | Istanbul | 34010 | Turkey (Türkiye) |
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| Derriford Hospital ( Site 1304) | Recruiting | Plymouth | Devon | Pl6 8DH | United Kingdom |
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| The Christie NHS Foundation Trust ( Site 1300) | Recruiting | Manchester | M20 4BX | United Kingdom |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008224 | Lymphoma, Follicular |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| 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 |
| D016393 | Lymphoma, B-Cell |
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