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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
280
Intravenous (IV) Infusion or Subcutaneous (SC) injection
Colorado Blood Cancer Institute ( Site 7000)
Denver, Colorado, United States
RECRUITINGSCRI Oncology Partners ( Site 0100)
Nashville, Tennessee, United States
RECRUITINGInstituto Alexander Fleming ( Site 1404)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
RECRUITINGHospital Universitario Austral ( Site 1402)
Pilar, Buenos Aires, Argentina
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.
Time frame: Up to approximately 49 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.
Time frame: 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.
Time frame: Up to approximately 28 days
Arms 1, 2, 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, 2, and 4, the percentage of participants who experience CR or PR as assessed by BICR will be presented.
Time frame: Up to approximately 49 months
Arms 1, 2, 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, 2, and 4.
Time frame: Up to approximately 49 months
Arm 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 Arm 3.
Time frame: Up to approximately 49 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.
Time frame: Pre-dose and at designated time points post-dose up to 12 months
Trough Concentration (Ctrough) of MK-1045
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Sanatorio Nuestra Senora del Rosario ( Site 1403)
Rosario, Santa Fe Province, Argentina
RECRUITINGHospital Aleman ( Site 1400)
CABA, Argentina
RECRUITINGTownsville University Hospital ( Site 0204)
Townsville, Queensland, Australia
RECRUITINGBox Hill Hospital ( Site 0202)
Box Hill, Victoria, Australia
RECRUITINGPrincess Margaret Cancer Centre ( Site 0301)
Toronto, Ontario, Canada
RECRUITINGClínica Alemana de Santiago ( Site 1608)
Santiago, Region M. de Santiago, Chile
RECRUITING...and 31 more locations
Blood samples will be collected to determine the Ctrough of MK-1045 in plasma.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 49 months