Study of MK-8808 for Participants With Follicular Lymphoma (MK-8808-001)

Phase 1

Terminated

• Conditions: Follicular Lymphoma
• Interventions: Drug: MK-8808; Drug: cyclophosphamide; Drug: vincristine; Drug: prednisolone

• Registration Number: NCT01370694
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2011-05-18
• Study First Submitted QC: 2011-06-09
• Study First Posted: 2011-06-10
• Study Start: 2011-08-19
• Primary Completion: 2014-12-01
• Study Completion: 2014-12-01
• Results First Submitted: 2015-10-23
• Results First Submitted QC: 2015-10-23
• Results First Posted: 2015-11-25
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-28
• Last Update Posted: 2019-03-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MK-8808 Combination Therapy	vincristine	Participants received MK-8808 375 mg/m\^2 intravenously (IV) + cyclophosphamide 750 mg/m\^2 IV + vincristine 1.4 mg/m\^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m\^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m\^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
MK-8808 Combination Therapy	MK-8808	Participants received MK-8808 375 mg/m\^2 intravenously (IV) + cyclophosphamide 750 mg/m\^2 IV + vincristine 1.4 mg/m\^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m\^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m\^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
MK-8808 Combination Therapy	cyclophosphamide	Participants received MK-8808 375 mg/m\^2 intravenously (IV) + cyclophosphamide 750 mg/m\^2 IV + vincristine 1.4 mg/m\^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m\^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m\^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
MK-8808 Combination Therapy	prednisolone	Participants received MK-8808 375 mg/m\^2 intravenously (IV) + cyclophosphamide 750 mg/m\^2 IV + vincristine 1.4 mg/m\^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m\^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m\^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs) During MK-8808/CVP Combination Therapy	From first dose of combination therapy up to 24 weeks	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.
Number of Participants Experiencing Clinical and Laboratory AEs During MK-8808 Maintenance Therapy	From first dose of single agent MK-8808 up to 2 years	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.

Secondary Outcome Measures

Name	Time	Method
Cmax of Plasma Levels of MK-8808 During Single Agent Maintenance Therapy	Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)	Cmax is a measure of the maximum amount of drug in the plasma over time using samples taken at specified time points.
Lowest Concentration (Ctrough) of Plasma Levels of MK-8808 When Used in Combination With CVP	Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)	Ctrough is a measure of the lowest level of drug in the plasma over time, using plasma samples collected at specified time points.
Maximum Concentration (Cmax) of Plasma Levels of MK-8808 When Used in Combination With CVP	Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)	Cmax is a measure of the maximum concentration of the drug in the plasma as measured using plasma samples taken over specified time points.
Ctrough of Plasma Levels of MK-8808 When Used as Single Agent Maintenance	Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)	Ctrough is a measure of the lowest level of drug in the plasma over time, using plasma samples collected at specified time points.
Clinical Response of Tumor to MK-8808/CVP Combination Therapy	Up to 2 years	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.