Trial Outcomes & Findings for A Study of MK-3415, MK-6072, and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-001) (NCT NCT01241552)

Last Updated: 2018-09-05

Results Overview

CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic Clostridium (C.) difficile following clinical cure of the initial CDI episode

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1452 participants

Primary outcome timeframe

Up to 12 weeks

Results posted on

2018-09-05

Participant Flow

Participants 18 years of age or older, with a diagnosis of Clostridium difficile Infection (CDI) were enrolled in this trial.

Participant milestones

Participant milestones
Measure	MK-3415 + SOC Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care (SOC) for CDI	MK-6072 + SOC Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI	MK-3415A + SOC Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI	Placebo + SOC Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
Overall Study STARTED	242	403	403	404
Overall Study Treated	235	392	388	397
Overall Study COMPLETED	201	340	343	340
Overall Study NOT COMPLETED	41	63	60	64

Reasons for withdrawal

Reasons for withdrawal
Measure	MK-3415 + SOC Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care (SOC) for CDI	MK-6072 + SOC Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI	MK-3415A + SOC Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI	Placebo + SOC Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
Overall Study Lack of Efficacy	1	0	0	0
Overall Study Death	26	30	20	25
Overall Study Adverse Event	1	1	0	0
Overall Study Technical Problems	2	0	2	2
Overall Study Progressive Disease	0	0	1	2
Overall Study Protocol Violation	0	2	6	1
Overall Study Withdrawal by Subject	7	15	14	15
Overall Study Physician Decision	2	4	2	3
Overall Study Lost to Follow-up	2	11	15	16

Baseline Characteristics

A Study of MK-3415, MK-6072, and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-001)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK-3415 + SOC n=242 Participants Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI	MK-6072 + SOC n=403 Participants Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI	MK-3415A + SOC n=403 Participants Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI	Placebo + SOC n=404 Participants Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI	Total n=1452 Participants Total of all reporting groups
Age, Continuous	64.2 Years STANDARD_DEVIATION 16.8 • n=93 Participants	61.1 Years STANDARD_DEVIATION 18.5 • n=4 Participants	62.5 Years STANDARD_DEVIATION 17.8 • n=27 Participants	62.9 Years STANDARD_DEVIATION 18.3 • n=483 Participants	62.5 Years STANDARD_DEVIATION 18.0 • n=36 Participants
Sex: Female, Male Female	137 Participants n=93 Participants	238 Participants n=4 Participants	224 Participants n=27 Participants	230 Participants n=483 Participants	829 Participants n=36 Participants
Sex: Female, Male Male	105 Participants n=93 Participants	165 Participants n=4 Participants	179 Participants n=27 Participants	174 Participants n=483 Participants	623 Participants n=36 Participants

PRIMARY outcome

Timeframe: Up to 12 weeks

Population: Participants who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.

Outcome measures

Outcome measures
Measure	MK-3415 + SOC n=232 Participants Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI	MK-6072 + SOC n=386 Participants Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI	MK-3415A + SOC n=383 Participants Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI	Placebo + SOC n=395 Participants Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
Percentage of Participants With Clostridium Difficile Infection (CDI) Recurrence	25.9 Percentage of participants	17.4 Percentage of participants	15.9 Percentage of participants	27.6 Percentage of participants

PRIMARY outcome

Timeframe: Up to 28 days

Population: All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specific procedure, whether or not considered related to the medicinal product or protocol specific procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

Outcome measures

Outcome measures
Measure	MK-3415 + SOC n=235 Participants Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI	MK-6072 + SOC n=390 Participants Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI	MK-3415A + SOC n=387 Participants Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI	Placebo + SOC n=400 Participants Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
Percentage of Participants With One or More Adverse Events (AEs) During 4 Weeks Following Infusion	67.2 Percentage of participants	65.4 Percentage of participants	59.7 Percentage of participants	62.0 Percentage of participants

PRIMARY outcome

Timeframe: Up to 28 days

Outcome measures

Outcome measures
Measure	MK-3415 + SOC n=235 Participants Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI	MK-6072 + SOC n=390 Participants Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI	MK-3415A + SOC n=387 Participants Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI	Placebo + SOC n=400 Participants Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
Percentage of Participants With Any Drug-related AE During 4 Weeks Following Infusion	7.2 Percentage of participants	8.2 Percentage of participants	6.2 Percentage of participants	5.0 Percentage of participants

PRIMARY outcome

Timeframe: Up to 28 days

A SAE is any AE occurring at any dose or during any use of Sponsor's product that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer, or is associated with an overdose (whether accidental or intentional); or is other important medical events.

Outcome measures

Outcome measures
Measure	MK-3415 + SOC n=235 Participants Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI	MK-6072 + SOC n=390 Participants Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI	MK-3415A + SOC n=387 Participants Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI	Placebo + SOC n=400 Participants Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
Percentage of Participants With Any Serious Adverse Events (SAEs) During 4 Weeks Following Infusion	27.7 Percentage of participants	21.5 Percentage of participants	14.7 Percentage of participants	20.0 Percentage of participants

PRIMARY outcome

Timeframe: Up to 28 days

Outcome measures

Outcome measures
Measure	MK-3415 + SOC n=235 Participants Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI	MK-6072 + SOC n=390 Participants Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI	MK-3415A + SOC n=387 Participants Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI	Placebo + SOC n=400 Participants Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
Percentage of Participants With Any Serious Drug-related Adverse Events During 4 Weeks Following Infusion	1.3 Percentage of participants	1.0 Percentage of participants	0.5 Percentage of participants	0.3 Percentage of participants

PRIMARY outcome

Timeframe: Up to 28 days

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specific procedure, whether or not considered related to the medicinal product or protocol-specific procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.

Outcome measures

Outcome measures
Measure	MK-3415 + SOC n=235 Participants Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI	MK-6072 + SOC n=390 Participants Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI	MK-3415A + SOC n=387 Participants Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI	Placebo + SOC n=400 Participants Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
Percentage of Participants Who Discontinued Study Medication Due to an AE During 4 Weeks Following Infusion	0.4 Percentage of participants	0.3 Percentage of participants	0.0 Percentage of participants	0.0 Percentage of participants

PRIMARY outcome

Timeframe: Up to 24 hours

Infusion-specific AEs included local infusion site AEs; and systemic AEs which include nausea, vomiting, chills, fatigue, feeling hot, infusion site conditions (bruising, coldness, erythema, extravasation, pain, phlebitis, pruritus), pyrexia, arthralgia, musculoskeletal pain, myalgia, dizziness, headache, dysphonia, nasal congestion, pruritus, rash, pruritic rash, urticaria, flushing, hot flush, hypertension, and hypotension.

Outcome measures

Outcome measures
Measure	MK-3415 + SOC n=235 Participants Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI	MK-6072 + SOC n=390 Participants Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI	MK-3415A + SOC n=387 Participants Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI	Placebo + SOC n=400 Participants Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
Percentage of Participants With Infusion-specific AEs	11.1 Percentage of participants	11.8 Percentage of participants	8.8 Percentage of participants	7.5 Percentage of participants

SECONDARY outcome

Timeframe: Up to 12 weeks

Global Cure is defined as the clinical cure of the initial CDI episode and no CDI recurrence through Week 12. Clinical cure is defined as participants who received ≤ 14 day regimen of SOC therapy and have no diarrhea (≤2 loose stools per 24 hours) for two consecutive days following completion of SOC therapy for the initial CDI episode.

Outcome measures

Outcome measures
Measure	MK-3415 + SOC n=232 Participants Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI	MK-6072 + SOC n=386 Participants Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI	MK-3415A + SOC n=383 Participants Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI	Placebo + SOC n=395 Participants Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
Percentage of Participants With Global Cure	47.0 Percentage of participants	60.1 Percentage of participants	58.7 Percentage of participants	55.2 Percentage of participants

SECONDARY outcome

Timeframe: Up to 12 weeks

CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode. Clinical cure is defined as participants who received ≤ 14 day regimen of SOC therapy and have no diarrhea (≤2 loose stools per 24 hours) for two consecutive days following completion of SOC therapy for the baseline CDI episode.

Outcome measures

Outcome measures
Measure	MK-3415 + SOC n=169 Participants Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI	MK-6072 + SOC n=299 Participants Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI	MK-3415A + SOC n=286 Participants Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI	Placebo + SOC n=327 Participants Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
Percentage of Participants With CDI Recurrence in Those With Clinical Cure of the Initial CDI Episode	35.5 Percentage of participants	22.4 Percentage of participants	21.3 Percentage of participants	33.3 Percentage of participants

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Participants ≥ 65 years of age at study entry who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.

Outcome measures

Outcome measures
Measure	MK-3415 + SOC n=122 Participants Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI	MK-6072 + SOC n=185 Participants Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI	MK-3415A + SOC n=200 Participants Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI	Placebo + SOC n=199 Participants Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
Percentage of Participants ≥ 65 Years of Age at Study Entry With CDI Recurrence	26.2 Percentage of participants	15.1 Percentage of participants	17.0 Percentage of participants	33.2 Percentage of participants

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Participants with a history of CDI in the 6 months prior to enrollment who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.

Outcome measures

Outcome measures
Measure	MK-3415 + SOC n=69 Participants Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI	MK-6072 + SOC n=103 Participants Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI	MK-3415A + SOC n=96 Participants Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI	Placebo + SOC n=109 Participants Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
Percentage of Participants With a History of CDI in the 6 Months Prior to Enrollment With CDI Recurrence	33.3 Percentage of participants	26.2 Percentage of participants	25.0 Percentage of participants	39.4 Percentage of participants

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Participants with clinically severe CDI at study entry who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.

CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode. Clinically severe CDI is defined as a Zar Score ≥ 2 based on the presence of 1 or more of the following: 1) age \>60 years old (1 point); 2)body temperature \>38.3°C (\>100°F) (1 point); 3) albumin level ˂2.5 mg/dL (1 point); 4) peripheral white blood cell count \>15,000 cells/mm\^3 within 48 hours (1 point); 5) endoscopic evidence of pseudomembranous colitis (2 points); and 6) treatment in Intensive Care Unit (2 points).

Outcome measures

Outcome measures
Measure	MK-3415 + SOC n=31 Participants Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI	MK-6072 + SOC n=67 Participants Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI	MK-3415A + SOC n=62 Participants Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI	Placebo + SOC n=60 Participants Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
Percentage of Participants With Clinically Severe CDI at Study Entry With CDI Recurrence	25.8 Percentage of participants	10.4 Percentage of participants	12.9 Percentage of participants	25.0 Percentage of participants

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Participants with the B1/NAP1/027 strain of C. difficile at study entry who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.

Outcome measures

Outcome measures
Measure	MK-3415 + SOC n=24 Participants Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI	MK-6072 + SOC n=46 Participants Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI	MK-3415A + SOC n=37 Participants Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI	Placebo + SOC n=36 Participants Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
Percentage of Participants With the B1/NAP1/027 Strain of C. Difficile at Study Entry With CDI Recurrence	33.3 Percentage of participants	26.1 Percentage of participants	10.8 Percentage of participants	36.1 Percentage of participants

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Participants with an epidemic strain of C. difficile at study entry who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.

Outcome measures

Outcome measures
Measure	MK-3415 + SOC n=57 Participants Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI	MK-6072 + SOC n=108 Participants Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI	MK-3415A + SOC n=106 Participants Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI	Placebo + SOC n=106 Participants Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
Percentage of Participants With an Epidemic Strain of C. Difficile (Ribotypes 027, 014, 002, 001, 106, and 020) at Study Entry With CDI Recurrence	24.6 Percentage of participants	23.1 Percentage of participants	19.8 Percentage of participants	35.8 Percentage of participants

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Participants with compromised immunity at study entry who received infusion of study medication; had a positive local stool test for toxigenic C. difficile; received protocol defined standard of care therapy within 1 day window of the infusion; and complied with Good Clinical Practice.

CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode. Compromised immunity is defined as follows: an active hematological malignancy (including leukemia, lymphoma, multiple myeloma), an active malignancy requiring recent cytotoxic chemotherapy, receipt of a prior hematopoietic stem cell transplant, receipt of a prior solid organ transplant, asplenia, or neutropenia/pancytopenia due to other conditions.

Outcome measures

Outcome measures
Measure	MK-3415 + SOC n=55 Participants Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI	MK-6072 + SOC n=87 Participants Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI	MK-3415A + SOC n=78 Participants Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI	Placebo + SOC n=92 Participants Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
Percentage of Participants With Compromised Immunity at Study Entry With CDI Recurrence	18.2 Percentage of participants	17.2 Percentage of participants	11.5 Percentage of participants	28.3 Percentage of participants

Adverse Events

MK-3415 + SOC

Serious events: 104 serious events

Other events: 84 other events

Deaths: 0 deaths

MK-6072 + SOC

Serious events: 120 serious events

Other events: 116 other events

Deaths: 0 deaths

MK-3415A + SOC

Serious events: 94 serious events

Other events: 110 other events

Deaths: 0 deaths

Placebo + SOC

Serious events: 126 serious events

Other events: 103 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	MK-3415 + SOC n=235 participants at risk Single intravenous (IV) infusion of 10 mg/kg MK-3415 + SOC for CDI	MK-6072 + SOC n=390 participants at risk Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI	MK-3415A + SOC n=387 participants at risk Single IV infusion of 10 mg/kg MK 3415A + SOC for CDI	Placebo + SOC n=400 participants at risk Normal saline infusion (0.9% sodium chloride) + SOC for CDI
Gastrointestinal disorders Abdominal pain	6.0% 14/235 • Number of events 15 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.	6.4% 25/390 • Number of events 32 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.	5.2% 20/387 • Number of events 21 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.	6.0% 24/400 • Number of events 28 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.
Gastrointestinal disorders Diarrhoea	7.7% 18/235 • Number of events 23 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.	6.4% 25/390 • Number of events 33 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.	8.5% 33/387 • Number of events 38 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.	6.8% 27/400 • Number of events 42 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.
Gastrointestinal disorders Nausea	12.8% 30/235 • Number of events 33 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.	8.2% 32/390 • Number of events 38 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.	8.5% 33/387 • Number of events 40 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.	7.5% 30/400 • Number of events 35 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.
Gastrointestinal disorders Vomiting	4.7% 11/235 • Number of events 13 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.	5.9% 23/390 • Number of events 29 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.	3.9% 15/387 • Number of events 18 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.	4.0% 16/400 • Number of events 16 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.
General disorders Fatigue	5.1% 12/235 • Number of events 13 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.	1.8% 7/390 • Number of events 7 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.	3.6% 14/387 • Number of events 15 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.	1.2% 5/400 • Number of events 5 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.
General disorders Pyrexia	6.0% 14/235 • Number of events 18 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.	5.9% 23/390 • Number of events 26 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.	3.4% 13/387 • Number of events 16 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.	3.8% 15/400 • Number of events 16 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.
Infections and infestations Urinary tract infection	6.4% 15/235 • Number of events 15 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.	4.6% 18/390 • Number of events 18 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.	3.9% 15/387 • Number of events 15 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.	5.0% 20/400 • Number of events 21 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.
Nervous system disorders Headache	6.4% 15/235 • Number of events 19 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.	5.1% 20/390 • Number of events 23 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.	5.7% 22/387 • Number of events 23 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.	3.5% 14/400 • Number of events 18 • Up to 90 days All randomized participants who received infusion of study medication, based on the treatment actually received. One participant randomized to receive MK-3415A, and two participants randomized to receive MK-6072 actually received placebo instead.

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. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
Publication restrictions are in place

Restriction type: OTHER