This study will evaluate the safety, pharmacokinetics, and anti-tumor activity of MK-8808 in combination with cyclophosphamide, vincristine, and prednisolone (CVP), and as a single agent, for participants with B-lymphocyte antigen cluster of differentiation 20 (CD20)-positive follicular lymphoma who have had no prior chemotherapy. The primary study hypothesis is that MK-8808 will be safe and well tolerated in combination with CVP and as a single agent.
The study was terminated early by the Sponsor due to business reasons. All participants were discontinued from MK-8808 + CVP, but could continue to receive maintenance therapy with MabThera™ (rituximab) per standard of care.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs) During MK-8808/CVP Combination Therapy
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Time frame: From first dose of combination therapy up to 24 weeks
Number of Participants Experiencing Clinical and Laboratory AEs During MK-8808 Maintenance Therapy
An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
Time frame: From first dose of single agent MK-8808 up to 2 years
Maximum Concentration (Cmax) of Plasma Levels of MK-8808 When Used in Combination With CVP
Cmax is a measure of the maximum concentration of the drug in the plasma as measured using plasma samples taken over specified time points.
Time frame: Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)
Cmax of Plasma Levels of MK-8808 During Single Agent Maintenance Therapy
Cmax is a measure of the maximum amount of drug in the plasma over time using samples taken at specified time points.
Time frame: Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)
Lowest Concentration (Ctrough) of Plasma Levels of MK-8808 When Used in Combination With CVP
Ctrough is a measure of the lowest level of drug in the plasma over time, using plasma samples collected at specified time points.
Time frame: Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)
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Ctrough of Plasma Levels of MK-8808 When Used as Single Agent Maintenance
Ctrough is a measure of the lowest level of drug in the plasma over time, using plasma samples collected at specified time points.
Time frame: Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)
Clinical Response of Tumor to MK-8808/CVP Combination Therapy
The response of the tumor to MK-8808/CVP combination therapy was radiographically assessed using Response Criteria Evaluation in Solid Tumors (RECIST). Response categories of partial response (PR), complete resonse (CR), and uncomfirmed (CRu) central review.
Time frame: Up to 2 years