Trial Outcomes & Findings for MK-3795 (PT2385) for the Treatment of Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma (MK-3795-003) (NCT NCT03108066)

Last Updated: 2024-09-24

Results Overview

ORR was defined as the percentage of participants in the analysis population who have a best confirmed response of Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). ORR was assessed by independent review committee (ICR) for the primary analysis.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Up to approximately 76 months

Results posted on

2024-09-24

Participant Flow

Participant milestones

Participant milestones
Measure	MK-3795 Participants received 800 mg MK-3795 orally twice daily. Participants continued to receive MK-3795 in the absence of unacceptable treatment related toxicity or unequivocal disease progression.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MK-3795 (PT2385) for the Treatment of Von Hippel-Lindau Disease-Associated Clear Cell Renal Cell Carcinoma (MK-3795-003)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK-3795 n=4 Participants Participants received 800 mg MK-3795 orally twice daily. Participants continued to receive MK-3795 in the absence of unacceptable treatment related toxicity or unequivocal disease progression.
Age, Continuous	58.3 Years STANDARD_DEVIATION 8.14 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 76 months

Population: The analysis population consisted of all allocated participants who received at least one dose of study intervention.

Outcome measures

Outcome measures
Measure	MK-3795 n=4 Participants Participants received 800 mg MK-3795 orally twice daily. Participants continued to receive MK-3795 in the absence of unacceptable treatment related toxicity or unequivocal disease progression.
Overall Response Rate (ORR) in VHL Disease-Associated ccRCC Tumors	0.0 Percentage of Participants Interval 0.0 to 60.2

SECONDARY outcome

Timeframe: Up to approximately 76 months

Population: The analysis population consisted of all allocated participants who received at least one dose of study intervention.

PFS was defined as the interval from the start of study treatment to the first documented Progressive Disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.

Outcome measures

Outcome measures
Measure	MK-3795 n=4 Participants Participants received 800 mg MK-3795 orally twice daily. Participants continued to receive MK-3795 in the absence of unacceptable treatment related toxicity or unequivocal disease progression.
Progression-free Survival (PFS) in VHL Disease-Associated ccRCC Tumors	NA Months NA = Median, upper limit, and lower limit not reached at time of data cut-off due to insufficient number of participants with an event.

SECONDARY outcome

Timeframe: Up to approximately 76 months

Population: The analysis population consisted of all allocated participants who received at least one dose of study intervention and experienced CR or PR. No participants experienced CR or PR and DOR was not analyzed.

DOR was defined as the interval from the first documented evidence of a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 until PD or death due to any cause, whichever occurs first, in participants demonstrating a best confirmed response of CR or PR. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 76 months

TTR was defined as the interval from the start of study treatment to the first documentation of a response per RECIST 1.1, and calculated for participants with a best confirmed response of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 76 months

Population: There were no reported non-ccRCC tumors in allocated participants, therefore no analysis was performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 76 months

Population: There were no reported non-ccRCC tumors in allocated participants, therefore no analysis was performed.

PFS was defined as the interval from the start of study treatment to the first documented PD or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 76 months

Population: There were no reported non-ccRCC tumors in allocated participants, therefore no analysis was performed.

DOR was defined as the interval from the first documented evidence of a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 until Progressive Disease (PD) or death due to any cause, whichever occurs first, in participants demonstrating a best confirmed response of CR or PR. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 76 months

Population: There were no reported non-ccRCC tumors in allocated participants, therefore no analysis was performed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 1: pre-dose and 6 hours post-dose, Week 3, 5, 9, 13, and 17: pre-dose

Population: The analysis population consisted of all allocated participants who received at least one dose of study intervention and had available MK-3475 plasma concentration data at the specified timepoints. No participants had available MK-3475 plasma concentration data at Week 17.

Blood samples for the determination of MK-3795 concentration were collected at pre-specified timepoints before and after administration of study intervention.

Outcome measures

Outcome measures
Measure	MK-3795 n=4 Participants Participants received 800 mg MK-3795 orally twice daily. Participants continued to receive MK-3795 in the absence of unacceptable treatment related toxicity or unequivocal disease progression.
MK-3795 Plasma Concentration Week 5 Pre-dose	1480 ng/mL Geometric Coefficient of Variation 93.5
MK-3795 Plasma Concentration Week 1 Pre-dose	NA ng/mL Geometric Coefficient of Variation NA NA means not calculable as MK-3795 could not be detected.
MK-3795 Plasma Concentration Week 1 6 Hours Post-dose	583 ng/mL Geometric Coefficient of Variation 104.6
MK-3795 Plasma Concentration Week 3 Pre-dose	1750 ng/mL Geometric Coefficient of Variation 76.8
MK-3795 Plasma Concentration Week 9 Pre-dose	2550 ng/mL Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated if the number of participants analyzed was less than 2.
MK-3795 Plasma Concentration Week 13 Pre-dose	3150 ng/mL Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated if the number of participants analyzed was less than 2.

SECONDARY outcome

Timeframe: Week 1: pre-dose and 6 hours post-dose, Week 3, 5, 9, 13, and 17: pre-dose

Population: The analysis population consisted of all allocated participants who received at least one dose of study intervention and had available MK-3475 metabolite plasma concentration data at the specified timepoints. No participants had available MK-3475 metabolite plasma concentration data at Week 17.

Blood samples for the determination of MK-3795 metabolite concentration were collected at pre-specified timepoints before and after administration of study intervention.

Outcome measures

Outcome measures
Measure	MK-3795 n=4 Participants Participants received 800 mg MK-3795 orally twice daily. Participants continued to receive MK-3795 in the absence of unacceptable treatment related toxicity or unequivocal disease progression.
MK-3795 Metabolite Plasma Concentration Week 5 Pre-dose	3440 ng/mL Geometric Coefficient of Variation 62.9
MK-3795 Metabolite Plasma Concentration Week 13 Pre-dose	6360 ng/mL Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated if the number of participants analyzed was less than 2.
MK-3795 Metabolite Plasma Concentration Week 1 Pre-dose	NA ng/mL Geometric Coefficient of Variation NA NA means not calculable as MK-3795 metabolite could not be detected.
MK-3795 Metabolite Plasma Concentration Week 1 6 Hours Post-dose	2790 ng/mL Geometric Coefficient of Variation 95.5
MK-3795 Metabolite Plasma Concentration Week 3 Pre-dose	4530 ng/mL Geometric Coefficient of Variation 53.7
MK-3795 Metabolite Plasma Concentration Week 9 Pre-dose	5790 ng/mL Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated if the number of participants analyzed was less than 2.

SECONDARY outcome

Timeframe: Up to approximately 76 months

Population: The analysis population consisted of all allocated participants who received at least one dose of study intervention.

An AE was defined as any untoward medical occurrence in a participant regardless of its causal relationship to study treatment. An AE can be any unfavorable and unintended sign (including any clinically significant abnormal laboratory test result), symptom, or disease temporally associated with the use of the study drug, whether or not it was considered to be study drug related.

Outcome measures

Outcome measures
Measure	MK-3795 n=4 Participants Participants received 800 mg MK-3795 orally twice daily. Participants continued to receive MK-3795 in the absence of unacceptable treatment related toxicity or unequivocal disease progression.
Number of Participants Who Experienced One or More Adverse Events (AEs)	4 Participants

SECONDARY outcome

Timeframe: Up to approximately 74 months

Population: The analysis population consisted of all allocated participants who received at least one dose of study intervention.

Outcome measures

Outcome measures
Measure	MK-3795 n=4 Participants Participants received 800 mg MK-3795 orally twice daily. Participants continued to receive MK-3795 in the absence of unacceptable treatment related toxicity or unequivocal disease progression.
Number of Participants Who Discontinued Study Intervention Due to an AE	2 Participants

Adverse Events

MK-3795

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MK-3795 n=4 participants at risk Participants received 800 mg MK-3795 orally twice daily. Participants continued to receive MK-3795 in the absence of unacceptable treatment related toxicity or unequivocal disease progression.
Nervous system disorders Aphasia	75.0% 3/4 • Number of events 3 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.

Other adverse events

Other adverse events
Measure	MK-3795 n=4 participants at risk Participants received 800 mg MK-3795 orally twice daily. Participants continued to receive MK-3795 in the absence of unacceptable treatment related toxicity or unequivocal disease progression.
Blood and lymphatic system disorders Anaemia	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Cardiac disorders Bradycardia	50.0% 2/4 • Number of events 2 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Eye disorders Dry eye	75.0% 3/4 • Number of events 3 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Eye disorders Photopsia	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Eye disorders Retinal haemorrhage	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Eye disorders Vision blurred	50.0% 2/4 • Number of events 3 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Eye disorders Vitreous floaters	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Gastrointestinal disorders Abdominal pain upper	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Gastrointestinal disorders Constipation	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Gastrointestinal disorders Diarrhoea	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Gastrointestinal disorders Dry mouth	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Gastrointestinal disorders Gastrooesophageal reflux disease	25.0% 1/4 • Number of events 3 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Gastrointestinal disorders Nausea	100.0% 4/4 • Number of events 4 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Gastrointestinal disorders Oral pain	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
General disorders Fatigue	75.0% 3/4 • Number of events 3 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
General disorders Oedema peripheral	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Infections and infestations Bronchitis	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Infections and infestations COVID-19	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Infections and infestations Herpes zoster cutaneous disseminated	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Infections and infestations Upper respiratory tract infection	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Investigations Mammogram abnormal	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Investigations Weight decreased	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Metabolism and nutrition disorders Hypercalcaemia	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Metabolism and nutrition disorders Hypercholesterolaemia	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Metabolism and nutrition disorders Hyperglycaemia	50.0% 2/4 • Number of events 3 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Metabolism and nutrition disorders Hypertriglyceridaemia	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Metabolism and nutrition disorders Hypophosphataemia	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Musculoskeletal and connective tissue disorders Arthralgia	50.0% 2/4 • Number of events 2 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Musculoskeletal and connective tissue disorders Back pain	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Musculoskeletal and connective tissue disorders Muscle spasms	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Musculoskeletal and connective tissue disorders Myalgia	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Musculoskeletal and connective tissue disorders Neck pain	50.0% 2/4 • Number of events 3 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Musculoskeletal and connective tissue disorders Pain in extremity	50.0% 2/4 • Number of events 3 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Nervous system disorders Aphasia	75.0% 3/4 • Number of events 4 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Nervous system disorders Cognitive disorder	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Nervous system disorders Disturbance in attention	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Nervous system disorders Dizziness	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Nervous system disorders Dysaesthesia	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Nervous system disorders Dysgeusia	25.0% 1/4 • Number of events 2 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Nervous system disorders Headache	50.0% 2/4 • Number of events 6 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Nervous system disorders Neuralgia	25.0% 1/4 • Number of events 2 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Nervous system disorders Post herpetic neuralgia	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Nervous system disorders Tremor	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Psychiatric disorders Anxiety	50.0% 2/4 • Number of events 2 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Psychiatric disorders Depression	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Psychiatric disorders Insomnia	50.0% 2/4 • Number of events 3 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Psychiatric disorders Irritability	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Renal and urinary disorders Proteinuria	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Renal and urinary disorders Urinary retention	25.0% 1/4 • Number of events 2 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Respiratory, thoracic and mediastinal disorders Sinus pain	25.0% 1/4 • Number of events 4 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Skin and subcutaneous tissue disorders Macule	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Skin and subcutaneous tissue disorders Pruritus	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Skin and subcutaneous tissue disorders Rash maculo-papular	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.
Vascular disorders Hypotension	25.0% 1/4 • Number of events 1 • Up to approximately 76 months Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all allocated participants. Data are reported by treatment received.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor reserves the right to review all planned communications and manuscripts based on the results of this study. This reservation of right is not intended to restrict or hinder publication of any dissemination of study results, but to allow the Sponsor to confirm the accuracy of the data, to protect proprietary information, and to provide comments based on information that may not yet be available to the study Investigators.
Publication restrictions are in place

Restriction type: OTHER