Trial Outcomes & Findings for A Study of Pegylated Interferon Alfa-2b (MK-4031) as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (MK-4031-370) (NCT NCT01636960)
NCT ID: NCT01636960
Last Updated: 2018-08-08
Results Overview
A DLT was an event (clinical or laboratory) that resulted in a change in the given dose.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
9 participants
Primary outcome timeframe
From first dose to end of induction phase; up to 8 Weeks
Results posted on
2018-08-08
Participant Flow
This study enrolled Japanese participants with Stage II or III malignant melanoma who had undergone surgical resection and lymphadenectomy.
Participant milestones
| Measure |
Participants Receiving PegIFN Alfa-2b
Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
|
|---|---|
|
Induction Phase
STARTED
|
9
|
|
Induction Phase
COMPLETED
|
7
|
|
Induction Phase
NOT COMPLETED
|
2
|
|
Maintenance Phase
STARTED
|
7
|
|
Maintenance Phase
COMPLETED
|
0
|
|
Maintenance Phase
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Participants Receiving PegIFN Alfa-2b
Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
|
|---|---|
|
Induction Phase
Adverse Event
|
2
|
|
Maintenance Phase
Continued drug after regulatory approval
|
3
|
|
Maintenance Phase
Adverse Event
|
3
|
|
Maintenance Phase
Progressive disease
|
1
|
Baseline Characteristics
A Study of Pegylated Interferon Alfa-2b (MK-4031) as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (MK-4031-370)
Baseline characteristics by cohort
| Measure |
Participants Receiving PegIFN Alfa-2b
n=9 Participants
Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
|
|---|---|
|
Age, Continuous
|
43.3 Years
STANDARD_DEVIATION 13.7 • n=93 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From first dose to end of induction phase; up to 8 WeeksPopulation: All participants in the induction phase of the study
A DLT was an event (clinical or laboratory) that resulted in a change in the given dose.
Outcome measures
| Measure |
Participants Receiving PegIFN Alfa-2b
n=9 Participants
Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
|
|---|---|
|
Number of Participants Experiencing Dose-limiting Toxicities (DLTs) - Induction Phase
|
2 Participants
|
SECONDARY outcome
Timeframe: From first dose through follow-up; up to 265 WeeksPopulation: All participants who received at least one dose of study drug.
An adverse event was 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
| Measure |
Participants Receiving PegIFN Alfa-2b
n=9 Participants
Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
|
|---|---|
|
Safety: Number of Participants Experiencing Adverse Events (AEs)
|
9 Participants
|
SECONDARY outcome
Timeframe: From first dose to last dose of treatment; up to 260 WeeksPopulation: All participants receiving at least one dose of study drug.
An adverse event was 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
| Measure |
Participants Receiving PegIFN Alfa-2b
n=9 Participants
Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
|
|---|---|
|
Number of Participants Discontinuing Study Drug Because of AEs
|
5 Participants
|
Adverse Events
Participants Receiving PegIFN Alfa-2b
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Participants Receiving PegIFN Alfa-2b
n=9 participants at risk
Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
22.2%
2/9 • Number of events 5 • From first dose through follow-up; up to 265 Weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Ear and labyrinth disorders
Vertigo positional
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Infections and infestations
Conjunctivitis
|
22.2%
2/9 • Number of events 3 • From first dose through follow-up; up to 265 Weeks
|
|
Eye disorders
Eye pain
|
11.1%
1/9 • Number of events 3 • From first dose through follow-up; up to 265 Weeks
|
|
Eye disorders
Photophobia
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Eye disorders
Punctate keratitis
|
22.2%
2/9 • Number of events 2 • From first dose through follow-up; up to 265 Weeks
|
|
Eye disorders
Retinopathy
|
22.2%
2/9 • Number of events 2 • From first dose through follow-up; up to 265 Weeks
|
|
Eye disorders
Vitreous floaters
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Gastrointestinal disorders
Constipation
|
33.3%
3/9 • Number of events 3 • From first dose through follow-up; up to 265 Weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
3/9 • Number of events 5 • From first dose through follow-up; up to 265 Weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Gastrointestinal disorders
Nausea
|
66.7%
6/9 • Number of events 12 • From first dose through follow-up; up to 265 Weeks
|
|
Gastrointestinal disorders
Periodontal disease
|
11.1%
1/9 • Number of events 2 • From first dose through follow-up; up to 265 Weeks
|
|
Gastrointestinal disorders
Stomatitis
|
33.3%
3/9 • Number of events 3 • From first dose through follow-up; up to 265 Weeks
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
2/9 • Number of events 2 • From first dose through follow-up; up to 265 Weeks
|
|
General disorders
Chills
|
66.7%
6/9 • Number of events 13 • From first dose through follow-up; up to 265 Weeks
|
|
General disorders
Fatigue
|
55.6%
5/9 • Number of events 7 • From first dose through follow-up; up to 265 Weeks
|
|
General disorders
Injection site erythema
|
33.3%
3/9 • Number of events 3 • From first dose through follow-up; up to 265 Weeks
|
|
General disorders
Injection site extravasation
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
General disorders
Injection site pruritus
|
33.3%
3/9 • Number of events 3 • From first dose through follow-up; up to 265 Weeks
|
|
General disorders
Injection site reaction
|
66.7%
6/9 • Number of events 29 • From first dose through follow-up; up to 265 Weeks
|
|
General disorders
Malaise
|
66.7%
6/9 • Number of events 23 • From first dose through follow-up; up to 265 Weeks
|
|
General disorders
Oedema peripheral
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
General disorders
Pyrexia
|
100.0%
9/9 • Number of events 33 • From first dose through follow-up; up to 265 Weeks
|
|
Infections and infestations
Adenoiditis
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Infections and infestations
Cystitis
|
11.1%
1/9 • Number of events 2 • From first dose through follow-up; up to 265 Weeks
|
|
Infections and infestations
Gastroenteritis bacterial
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Infections and infestations
Gingivitis
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Infections and infestations
Pericoronitis
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
44.4%
4/9 • Number of events 8 • From first dose through follow-up; up to 265 Weeks
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Injury, poisoning and procedural complications
Laceration
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Injury, poisoning and procedural complications
Procedural pain
|
11.1%
1/9 • Number of events 2 • From first dose through follow-up; up to 265 Weeks
|
|
Investigations
Alanine aminotransferase increased
|
88.9%
8/9 • Number of events 8 • From first dose through follow-up; up to 265 Weeks
|
|
Investigations
Aspartate aminotransferase increased
|
88.9%
8/9 • Number of events 11 • From first dose through follow-up; up to 265 Weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
22.2%
2/9 • Number of events 2 • From first dose through follow-up; up to 265 Weeks
|
|
Investigations
Lymphocyte count decreased
|
22.2%
2/9 • Number of events 6 • From first dose through follow-up; up to 265 Weeks
|
|
Investigations
Neutrophil count decreased
|
100.0%
9/9 • Number of events 21 • From first dose through follow-up; up to 265 Weeks
|
|
Investigations
Platelet count decreased
|
55.6%
5/9 • Number of events 7 • From first dose through follow-up; up to 265 Weeks
|
|
Investigations
Weight decreased
|
55.6%
5/9 • Number of events 6 • From first dose through follow-up; up to 265 Weeks
|
|
Investigations
White blood cell count decreased
|
100.0%
9/9 • Number of events 19 • From first dose through follow-up; up to 265 Weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
44.4%
4/9 • Number of events 9 • From first dose through follow-up; up to 265 Weeks
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
22.2%
2/9 • Number of events 3 • From first dose through follow-up; up to 265 Weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
44.4%
4/9 • Number of events 9 • From first dose through follow-up; up to 265 Weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
22.2%
2/9 • Number of events 4 • From first dose through follow-up; up to 265 Weeks
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
22.2%
2/9 • Number of events 2 • From first dose through follow-up; up to 265 Weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
9/9 • Number of events 20 • From first dose through follow-up; up to 265 Weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
66.7%
6/9 • Number of events 10 • From first dose through follow-up; up to 265 Weeks
|
|
Nervous system disorders
Dizziness
|
22.2%
2/9 • Number of events 3 • From first dose through follow-up; up to 265 Weeks
|
|
Nervous system disorders
Dysgeusia
|
11.1%
1/9 • Number of events 2 • From first dose through follow-up; up to 265 Weeks
|
|
Nervous system disorders
Headache
|
55.6%
5/9 • Number of events 63 • From first dose through follow-up; up to 265 Weeks
|
|
Psychiatric disorders
Insomnia
|
22.2%
2/9 • Number of events 2 • From first dose through follow-up; up to 265 Weeks
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.2%
2/9 • Number of events 2 • From first dose through follow-up; up to 265 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
22.2%
2/9 • Number of events 2 • From first dose through follow-up; up to 265 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
44.4%
4/9 • Number of events 5 • From first dose through follow-up; up to 265 Weeks
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
1/9 • Number of events 3 • From first dose through follow-up; up to 265 Weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
3/9 • Number of events 4 • From first dose through follow-up; up to 265 Weeks
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Eye disorders
Chalazion
|
11.1%
1/9 • Number of events 3 • From first dose through follow-up; up to 265 Weeks
|
|
Eye disorders
Ocular discomfort
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
General disorders
Influenza like illness
|
22.2%
2/9 • Number of events 2 • From first dose through follow-up; up to 265 Weeks
|
|
General disorders
Injection site joint pain
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Gastrointestinal disorders
Gastritis
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Infections and infestations
Skin infection
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Investigations
Blood lactate dehydrogenase increased
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Nervous system disorders
Hypoaesthesia
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Nervous system disorders
Loss of consciousness
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Nervous system disorders
Quadriplegia
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Renal and urinary disorders
Proteinuria
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Renal and urinary disorders
Urinary tract disorder
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
11.1%
1/9 • Number of events 2 • From first dose through follow-up; up to 265 Weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
11.1%
1/9 • Number of events 2 • From first dose through follow-up; up to 265 Weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
11.1%
1/9 • Number of events 2 • From first dose through follow-up; up to 265 Weeks
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
11.1%
1/9 • Number of events 1 • From first dose through follow-up; up to 265 Weeks
|
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 Investigator agrees not to publish or publicly present any interim results of the trial without prior written consent of the Sponsor. The Investigator further agrees to provide review copies of abstracts or manuscripts (both oral and textual including transmission through any electronic medium). No publication or manuscript shall contain any trade secret information of the Sponsor or any proprietary or confidential information of the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER