Trial Outcomes & Findings for A Phase II Study of Pegylated Interferon Alfa-2b for the Adjuvant Treatment of Melanoma Subjects in Russia (MK-4031-400) (NCT NCT02155322)
NCT ID: NCT02155322
Last Updated: 2018-08-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
From first dose through follow-up; up to 13 months
Results posted on
2018-08-23
Participant Flow
This study enrolled Russian participants with malignant melanoma who had undergone surgical resection and lymphadenectomy.
Participant milestones
| Measure |
PEG-IFN
Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
Treated
|
32
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
PEG-IFN
Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Relapse/Recurrence
|
8
|
|
Overall Study
Withdrawal by Subject
|
4
|
Baseline Characteristics
A Phase II Study of Pegylated Interferon Alfa-2b for the Adjuvant Treatment of Melanoma Subjects in Russia (MK-4031-400)
Baseline characteristics by cohort
| Measure |
PEG-IFN
n=33 Participants
Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).
|
|---|---|
|
Age, Continuous
|
51.4 Years
STANDARD_DEVIATION 12.86 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose through follow-up; up to 13 monthsPopulation: 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 |
PEG-IFN
n=32 Participants
Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).
|
|---|---|
|
Percentage of Participants Experiencing Adverse Events (AEs)
|
100.0 Percentage of participants
|
PRIMARY outcome
Timeframe: From first dose to last dose of treatment; up to 12 monthsPopulation: 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 |
PEG-IFN
n=32 Participants
Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).
|
|---|---|
|
Percentage of Participants Discontinuing Study Drug Because of AEs
|
3.1 Percentage of participants
|
Adverse Events
PEG-IFN
Serious events: 5 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PEG-IFN
n=32 participants at risk
Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).
|
|---|---|
|
Blood and lymphatic system disorders
MONOCYTOSIS
|
3.1%
1/32 • Number of events 1 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
3.1%
1/32 • Number of events 1 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
CHOLECYSTITIS CHRONIC
|
3.1%
1/32 • Number of events 1 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
3.1%
1/32 • Number of events 1 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
3.1%
1/32 • Number of events 1 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
TYPE 1 DIABETES MELLITUS
|
3.1%
1/32 • Number of events 1 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
LEUKOCYTURIA
|
3.1%
1/32 • Number of events 1 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
PROTEINURIA
|
3.1%
1/32 • Number of events 1 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
URINARY TRACT PAIN
|
3.1%
1/32 • Number of events 1 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
Vascular disorders
HAEMORRHAGE
|
3.1%
1/32 • Number of events 1 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
Vascular disorders
VENOUS THROMBOSIS LIMB
|
3.1%
1/32 • Number of events 1 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
PEG-IFN
n=32 participants at risk
Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
15.6%
5/32 • Number of events 5 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
28.1%
9/32 • Number of events 11 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
18.8%
6/32 • Number of events 9 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
25.0%
8/32 • Number of events 9 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
NAUSEA
|
21.9%
7/32 • Number of events 8 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
General disorders
ASTHENIA
|
37.5%
12/32 • Number of events 12 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
General disorders
FATIGUE
|
21.9%
7/32 • Number of events 15 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
21.9%
7/32 • Number of events 42 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
18.8%
6/32 • Number of events 8 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
General disorders
PYREXIA
|
81.2%
26/32 • Number of events 62 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
53.1%
17/32 • Number of events 32 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
53.1%
17/32 • Number of events 34 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
Investigations
PLATELET COUNT DECREASED
|
6.2%
2/32 • Number of events 2 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
9.4%
3/32 • Number of events 3 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
6.2%
2/32 • Number of events 3 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
DIZZINESS
|
6.2%
2/32 • Number of events 2 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
HEADACHE
|
12.5%
4/32 • Number of events 6 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
DEPRESSION
|
6.2%
2/32 • Number of events 2 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
9.4%
3/32 • Number of events 3 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
6.2%
2/32 • Number of events 2 • From first dose through follow-up; up to 13 months
AEs for all participants who received at least one dose of study drug.
|
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 trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER