Trial Outcomes & Findings for Study of MK-8808 for Participants With Follicular Lymphoma (MK-8808-001) (NCT NCT01370694)

Last Updated: 2019-03-15

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

7 participants

Primary outcome timeframe

From first dose of combination therapy up to 24 weeks

Results posted on

2019-03-15

Participant Flow

The study was terminated early by the Sponsor due to business reasons. All participants were discontinued from MK-8808 on 18 March 2014, but could continue to receive maintenance therapy with rituximab per standard of care.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	7
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Switched to rituximab	4
Overall Study Progressive disease	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK-8808 Combination Therapy n=7 Participants 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.
Age, Continuous	56.1 Years STANDARD_DEVIATION 16.4 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose of combination therapy up to 24 weeks

Population: All participants receiving at least one dose of any study drug.

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.

Outcome measures

Outcome measures
Measure	MK-8808 Combination Therapy n=7 Participants 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.
Number of Participants Experiencing Clinical and Laboratory Adverse Events (AEs) During MK-8808/CVP Combination Therapy	6 Participants

PRIMARY outcome

Timeframe: From first dose of single agent MK-8808 up to 2 years

Population: No participants progressed to MK-8808 single agent maintenance therapy; this outcome measure was not assessed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)

Population: This analysis was not done due to early termination of the study.

Cmax is a measure of the maximum concentration of the drug in the plasma as measured using plasma samples taken over specified time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)

Population: No participants progressed to MK-8808 single agent maintenance therapy; this outcome measure was not assessed.

Cmax is a measure of the maximum amount of drug in the plasma over time using samples taken at specified time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose and end of infusion in each 21-day cycle and at end of therapy visit (up to 24 weeks)

Population: This analysis was not done due to early termination of the study.

Ctrough is a measure of the lowest level of drug in the plasma over time, using plasma samples collected at specified time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose and end of infusion in every other cycle and at end of therapy visit (up to 2 years)

Population: No participants progressed to MK-8808 single agent maintenance therapy; this outcome measure was not assessed.

Ctrough is a measure of the lowest level of drug in the plasma over time, using plasma samples collected at specified time points.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: All participants with evaluable data

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.

Outcome measures

Outcome measures
Measure	MK-8808 Combination Therapy n=7 Participants 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.
Clinical Response of Tumor to MK-8808/CVP Combination Therapy PR	6 Participants
Clinical Response of Tumor to MK-8808/CVP Combination Therapy CR	0 Participants
Clinical Response of Tumor to MK-8808/CVP Combination Therapy CRu	0 Participants

Adverse Events

MK-8808 Combination Therapy

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MK-8808 Combination Therapy n=7 participants at risk 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.
Injury, poisoning and procedural complications Femoral neck fracture	14.3% 1/7 • Number of events 1 • Up to 30 days after last dose of CVP therapy (up to 28 weeks) Adverse events were not collected for participants who were switched to MabThera.

Other adverse events

Other adverse events
Measure	MK-8808 Combination Therapy n=7 participants at risk 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.
Blood and lymphatic system disorders Anaemia	14.3% 1/7 • Number of events 1 • Up to 30 days after last dose of CVP therapy (up to 28 weeks) Adverse events were not collected for participants who were switched to MabThera.
Cardiac disorders Tachycardia	14.3% 1/7 • Number of events 1 • Up to 30 days after last dose of CVP therapy (up to 28 weeks) Adverse events were not collected for participants who were switched to MabThera.
Eye disorders Blepharitis	14.3% 1/7 • Number of events 1 • Up to 30 days after last dose of CVP therapy (up to 28 weeks) Adverse events were not collected for participants who were switched to MabThera.
Immune system disorders Hypersensitivity	14.3% 1/7 • Number of events 1 • Up to 30 days after last dose of CVP therapy (up to 28 weeks) Adverse events were not collected for participants who were switched to MabThera.
Infections and infestations Bronchitis	14.3% 1/7 • Number of events 1 • Up to 30 days after last dose of CVP therapy (up to 28 weeks) Adverse events were not collected for participants who were switched to MabThera.
Infections and infestations Gastroenteritis	14.3% 1/7 • Number of events 1 • Up to 30 days after last dose of CVP therapy (up to 28 weeks) Adverse events were not collected for participants who were switched to MabThera.
Infections and infestations Pharyngotonsillitis	14.3% 1/7 • Number of events 1 • Up to 30 days after last dose of CVP therapy (up to 28 weeks) Adverse events were not collected for participants who were switched to MabThera.
Infections and infestations Skin infection	14.3% 1/7 • Number of events 1 • Up to 30 days after last dose of CVP therapy (up to 28 weeks) Adverse events were not collected for participants who were switched to MabThera.
Infections and infestations Upper respiratory tract infection	14.3% 1/7 • Number of events 1 • Up to 30 days after last dose of CVP therapy (up to 28 weeks) Adverse events were not collected for participants who were switched to MabThera.
Investigations Alanine aminotransferase increased	14.3% 1/7 • Number of events 2 • Up to 30 days after last dose of CVP therapy (up to 28 weeks) Adverse events were not collected for participants who were switched to MabThera.
Investigations Neutrophil count decreased	14.3% 1/7 • Number of events 1 • Up to 30 days after last dose of CVP therapy (up to 28 weeks) Adverse events were not collected for participants who were switched to MabThera.
Metabolism and nutrition disorders Hypercreatininaemia	14.3% 1/7 • Number of events 1 • Up to 30 days after last dose of CVP therapy (up to 28 weeks) Adverse events were not collected for participants who were switched to MabThera.
Skin and subcutaneous tissue disorders Rash	14.3% 1/7 • Number of events 1 • Up to 30 days after last dose of CVP therapy (up to 28 weeks) Adverse events were not collected for participants who were switched to MabThera.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
Publication restrictions are in place

Restriction type: OTHER