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

Tracking Information
First Submitted Date ICMJE	May 18, 2011
First Posted Date ICMJE	June 10, 2011
Results First Submitted Date	October 23, 2015
Results First Posted Date	November 25, 2015
Last Update Posted Date	July 7, 2017
Actual Study Start Date ICMJE	August 19, 2011
Actual Primary Completion Date	December 1, 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 23, 2015)	Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs) During MK-8808/CVP Combination Therapy [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures ICMJE; (submitted: June 9, 2011)	Number of participants experiencing clinical and laboratory adverse events (AEs) during combination therapy [ Time Frame: From first dose (baseline) of CVP therapy up to 30 days post last dose (up to eight 21-day cycles of combination therapy) ]; Number of participants experiencing clinical and laboratory AEs during single agent maintenance with MK-8808 [ Time Frame: From first dose (baseline) of single agent maintenance therapy up to 30 days after the last dose (up to 2 years) ]
Change History	Complete list of historical versions of study NCT01370694 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: April 25, 2016)	Maximum Concentration (Cmax) of Plasma Levels of MK-8808 When Used in Combination With CVP [ Time Frame: 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.; Cmax of Plasma Levels of MK-8808 During Single Agent Maintenance Therapy [ Time Frame: 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 [ Time Frame: 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.; Ctrough of Plasma Levels of MK-8808 When Used as Single Agent Maintenance [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures ICMJE; (submitted: June 9, 2011)	Maximum concentration (C[max]) in plasma levels of MK-8808 when used in combination with CVP [ Time Frame: Day 1 of all CVP cycles (up to eight 21-day cycles) ]; C[max] in plasma levels of MK-8808 when used as single agent maintenance [ Time Frame: Day 1 of every other bimonthly single agent maintenance therapy cycle; or Day 1 of each 6-month single agent maintenance cycle, up to 2 years ]; Lowest concentration (C[trough]) of plasma levels of MK-8808 when used in combination with CVP [ Time Frame: Day 1 of all CVP cycles (up to eight 21-day cycles) ]; C[trough] of plasma levels of MK-8808 when used as single agent maintenance [ Time Frame: Day 1 of every other bimonthly single agent maintenance therapy cycle; or Day 1 of each 6-month single agent maintenance cycle, up to 2 years ]; Clinical response [ Time Frame: Before each cycle of CVP (baseline), every 3 to 4 months during maintenance therapy, and approximately one month after last dose of MK-8808, up to 2 years ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Study of MK-8808 for Participants With Follicular Lymphoma (MK-8808-001)
Official Title ICMJE	An Open-Label, Single Arm Study of MK-8808 in Patients With Advanced CD20-Positive Follicular Lymphoma
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 Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Follicular Lymphoma
Intervention ICMJE	Drug: MK-8808; Drug: cyclophosphamide; Drug: vincristine; Drug: prednisolone
Study Arms	Experimental: MK-8808 Combination Therapy; 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.; Interventions: Drug: MK-8808; Drug: cyclophosphamide; Drug: vincristine; Drug: prednisolone
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: December 21, 2014)	7
Original Estimated Enrollment ICMJE; (submitted: June 9, 2011)	20
Actual Study Completion Date	December 1, 2014
Actual Primary Completion Date	December 1, 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion criteria: Histological diagnosis of CD20-positive follicular lymphoma, Grade 1, 2, or 3a (World Health Organization [WHO] 2008 classification) based on an excisional or incisional lymph node biopsy or a bone marrow biopsy.; Ann Arbor Stage III or IV disease.; Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.; Life expectancy >3 months with no expected need of immediate intervention to treat life-threatening complications.; Adequate organ function.; Participants must agree to use an adequate method of contraception starting with the first dose of study drug through 12 months (for females) or 90 days (for males) after the last dose of study drug. Exclusion criteria: Histological Grade 3b or with >50% diffuse architectural pattern.; Circulating malignant cells >25,000/mm^3; Presence or history of central nervous system (CNS) disease (either CNS lymphoma or lymphomatous meningitis).; Prior treatment with chemotherapy, rituximab, any other anti-CD20 compound, or any other type of anti-cancer compounds.; Radiotherapy within 2 months prior to Cycle 1 Day 1.; Current participation or has participated in a study with an investigational compound within 30 days prior to Cycle 1 Day 1.; Concomitant disease that requires continuous therapy with prednisone at doses >20 mg per day.; Any medical contraindication for prednisolone as being dosed in the CVP regimen.; Poorly controlled diabetes mellitus, as defined by institutional or local standards.; Grade >2 peripheral neuropathy.; Has one of the following: is human immunodeficiency virus (HIV)-positive is Hepatitis B surface antigen positive (HBsAg+) or is positive for antibodies to Hepatitis B core antigen (anti-HBcAg+) has antibodies to Hepatitis C virus; Has one or more of the following: Active tuberculosis based on institutional diagnostic criteria and local practice guidelines. Evidence of a tuberculosis infection based on a chest X-ray (CXR) or computed tomography (CT) scan performed within 3 months of dosing. History of a tuberculosis infection.; Major surgical procedure within 4 weeks prior to Cycle 1 Day 1.; Regular use (including "recreational" use) of any illicit drugs or recent history (within the last year) of drug or alcohol abuse or dependence.; Pregnant or breastfeeding.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries	Bulgaria, Philippines, Poland, Ukraine
Administrative Information
NCT Number ICMJE	NCT01370694
Other Study ID Numbers ICMJE	8808-001; 2011-000386-13 ( EudraCT Number )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Merck Sharp & Dohme Corp.
Study Sponsor ICMJE	Merck Sharp & Dohme Corp.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account	Merck Sharp & Dohme Corp.
Verification Date	June 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP