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Trial record 24 of 295 for:    IFNA2 AND PEG-interferon alfa-2b

SCH 54031 PEG12000 Interferon Alfa-2b (PEG Intron, MK-4031) vs. INTRON®A (SCH 30500, MK-2958) as Adjuvant Therapy for Melanoma (C98-135, MK-4031-002)

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ClinicalTrials.gov Identifier: NCT03552549
Recruitment Status : Terminated (This study was closed to enrollment prematurely due to sub-optimal accrual.)
First Posted : June 12, 2018
Results First Posted : July 24, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Melanoma
Interventions Biological: PEG-Intron
Biological: INTRON A
Enrollment 126
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PEG-Intron INTRON A
Hide Arm/Group Description Participants with stage III node positive cutaneous melanoma received subcutaneous PEG-Intron (6.0 ug/kg weekly) for up to 24 months post-surgery Participants with stage III node positive cutaneous melanoma received intravenous INTRON A (20 million international units [MIU]/m^2/day, 5 days a week) for 4 weeks followed by subcutaneous INTRON A (10 MIU/m^2 three times per week) for up to 12 months post-surgery
Period Title: Overall Study
Started 63 63
Treated 62 62
Completed 10 11
Not Completed 53 52
Reason Not Completed
Disease progression             25             17
Adverse event in first 12 months             12             8
Withdrawal by Subject             7             7
Unknown (no reason provided)             4             2
Not in participant's best interest             2             1
Did not complete study treatment             2             3
Did not meet eligibility criteria             1             0
Administrative             0             14
Arm/Group Title PEG-Intron INTRON A Total
Hide Arm/Group Description Participants with stage III node positive cutaneous melanoma received subcutaneous PEG-Intron (6.0 ug/kg weekly) for up to 24 months post-surgery Participants with stage III node positive cutaneous melanoma received intravenous INTRON A (20 million international units [MIU]/m^2/day, 5 days a week) for 4 weeks followed by subcutaneous INTRON A (10 MIU/m^2 three times per week) for up to 12 months post-surgery Total of all reporting groups
Overall Number of Baseline Participants 63 63 126
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants 62 participants 124 participants
48.1  (13.6) 49.2  (12.2) 48.6  (12.9)
[1]
Measure Analysis Population Description: Age is unknown for 1 participant in each treatment group.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 63 participants 126 participants
Female
24
  38.1%
22
  34.9%
46
  36.5%
Male
39
  61.9%
41
  65.1%
80
  63.5%
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description Progression-free survival time was defined as the time from the date of randomization to the date of disease progression or the date of death regardless of the cause. PFS was to be assessed by clinical observation, with recurrence documented by appropriate radiographic and histologic methods, and confirmed by Independent Central Review.
Time Frame From time of randomization to time of progression or death (up to approximately 26 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. Due to the early termination of this study, confirmation of PFS by Independent Central Review was not collected and; therefore, PFS could not be analyzed as planned per protocol.
Arm/Group Title PEG-Intron INTRON A
Hide Arm/Group Description:
Participants with stage III node positive cutaneous melanoma received subcutaneous PEG-Intron (6.0 ug/kg weekly) for up to 24 months post-surgery
Participants with stage III node positive cutaneous melanoma received intravenous INTRON A (20 million international units [MIU]/m^2/day, 5 days a week) for 4 weeks followed by subcutaneous INTRON A (10 MIU/m^2 three times per week) for up to 12 months post-surgery
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Overall Survival
Hide Description Overall survival (OS) is the time from randomization to death due to any cause. Participants were to be followed for survival every 3 months. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. After the early termination of the study, participants were followed for safety only. Although the OS analysis is not in the clinical study report due to early termination of the study, an OS ad hoc analysis was requested by the FDA and is therefore presented in this outcome measure. Below table presents the median duration of survival for participants.
Time Frame From time of randomization to time of death (up to approximately 26 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All treated participants.
Arm/Group Title PEG-Intron INTRON A
Hide Arm/Group Description:
Participants with stage III node positive cutaneous melanoma received subcutaneous PEG-Intron (6.0 ug/kg weekly) for up to 24 months post-surgery
Participants with stage III node positive cutaneous melanoma received intravenous INTRON A (20 million international units [MIU]/m^2/day, 5 days a week) for 4 weeks followed by subcutaneous INTRON A (10 MIU/m^2 three times per week) for up to 12 months post-surgery
Overall Number of Participants Analyzed 62 62
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(25.63 to NA)
23.72 [2] 
(20.67 to NA)
[1]

NA=Median OS could not be calculated due to an insufficient number of deaths on study (i.e. median OS was not reached).

NA=Upper limit OS could not be calculated due to an insufficient number of deaths on study (i.e. upper limit OS was not reached).

[2]
NA=Upper limit OS could not be calculated due to an insufficient number of deaths on study (i.e. upper limit OS was not reached).
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-Intron, INTRON A
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.71
Confidence Interval (2-Sided) 95%
0.28 to 1.77
Estimation Comments Hazard ratio presented as PEG-Intron/INTRON A; HR <1 indicates treatment effect in favor of PEG-Intron.
Time Frame Up to approximately 26 months
Adverse Event Reporting Description Analysis population includes all participants randomized/enrolled. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
 
Arm/Group Title PEG-Intron INTRON A
Hide Arm/Group Description Participants with stage III node positive cutaneous melanoma received subcutaneous PEG-Intron (6.0 ug/kg weekly) for up to 24 months post-surgery Participants with stage III node positive cutaneous melanoma received intravenous INTRON A (20 million international units [MIU]/m^2/day, 5 days a week) for 4 weeks followed by subcutaneous INTRON A (10 MIU/m^2 three times per week) for up to 12 months post-surgery
All-Cause Mortality
PEG-Intron INTRON A
Affected / at Risk (%) Affected / at Risk (%)
Total   11/63 (17.46%)      9/63 (14.29%)    
Show Serious Adverse Events Hide Serious Adverse Events
PEG-Intron INTRON A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/63 (38.10%)      19/63 (30.16%)    
Blood and lymphatic system disorders     
LYMPHADENOPATHY  1  3/63 (4.76%)  3 1/63 (1.59%)  1
NEUTROPENIA  1  1/63 (1.59%)  1 1/63 (1.59%)  1
THROMBOCYTOPENIA  1  1/63 (1.59%)  1 0/63 (0.00%)  0
Cardiac disorders     
TACHYARRHYTHMIA  1  0/63 (0.00%)  0 1/63 (1.59%)  1
Ear and labyrinth disorders     
VERTIGO  1  0/63 (0.00%)  0 2/63 (3.17%)  2
Eye disorders     
EYELID PTOSIS  1  0/63 (0.00%)  0 1/63 (1.59%)  1
VISION BLURRED  1  0/63 (0.00%)  0 1/63 (1.59%)  1
Gastrointestinal disorders     
ABDOMINAL PAIN  1  1/63 (1.59%)  1 0/63 (0.00%)  0
DIARRHOEA  1  1/63 (1.59%)  1 0/63 (0.00%)  0
NAUSEA  1  2/63 (3.17%)  2 0/63 (0.00%)  0
VOMITING  1  2/63 (3.17%)  2 2/63 (3.17%)  2
General disorders     
ASTHENIA  1  0/63 (0.00%)  0 1/63 (1.59%)  1
INJECTION SITE ERYTHEMA  1  1/63 (1.59%)  1 0/63 (0.00%)  0
INJECTION SITE NECROSIS  1  2/63 (3.17%)  3 0/63 (0.00%)  0
MUCOSAL INFLAMMATION  1  0/63 (0.00%)  0 1/63 (1.59%)  1
PYREXIA  1  0/63 (0.00%)  0 2/63 (3.17%)  2
Infections and infestations     
BRONCHITIS  1  1/63 (1.59%)  1 0/63 (0.00%)  0
CELLULITIS  1  1/63 (1.59%)  1 0/63 (0.00%)  0
GROIN INFECTION  1  1/63 (1.59%)  1 0/63 (0.00%)  0
INCISION SITE CELLULITIS  1  0/63 (0.00%)  0 1/63 (1.59%)  1
LOBAR PNEUMONIA  1  1/63 (1.59%)  1 0/63 (0.00%)  0
PNEUMONIA  1  1/63 (1.59%)  1 0/63 (0.00%)  0
POSTOPERATIVE WOUND INFECTION  1  1/63 (1.59%)  1 1/63 (1.59%)  1
URINARY TRACT INFECTION  1  1/63 (1.59%)  1 0/63 (0.00%)  0
WOUND ABSCESS  1  0/63 (0.00%)  0 1/63 (1.59%)  1
WOUND INFECTION  1  1/63 (1.59%)  1 0/63 (0.00%)  0
Injury, poisoning and procedural complications     
INJURY  1  1/63 (1.59%)  1 0/63 (0.00%)  0
PROCEDURAL PAIN  1  1/63 (1.59%)  1 0/63 (0.00%)  0
SEROMA  1  1/63 (1.59%)  1 0/63 (0.00%)  0
Investigations     
ALANINE AMINOTRANSFERASE INCREASED  1  2/63 (3.17%)  3 1/63 (1.59%)  1
ASPARTATE AMINOTRANSFERASE INCREASED  1  1/63 (1.59%)  2 0/63 (0.00%)  0
GRANULOCYTE COUNT DECREASED  1  1/63 (1.59%)  1 0/63 (0.00%)  0
HEPATIC ENZYME INCREASED  1  2/63 (3.17%)  2 4/63 (6.35%)  5
TRANSAMINASES INCREASED  1  1/63 (1.59%)  2 0/63 (0.00%)  0
WHITE BLOOD CELL COUNT DECREASED  1  1/63 (1.59%)  1 0/63 (0.00%)  0
Metabolism and nutrition disorders     
ANOREXIA  1  0/63 (0.00%)  0 1/63 (1.59%)  1
HYPERTRIGLYCERIDAEMIA  1  1/63 (1.59%)  1 0/63 (0.00%)  0
Musculoskeletal and connective tissue disorders     
MUSCULAR WEAKNESS  1  0/63 (0.00%)  0 1/63 (1.59%)  1
MYALGIA  1  0/63 (0.00%)  0 1/63 (1.59%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
BREAST CANCER  1  0/63 (0.00%)  0 1/63 (1.59%)  1
METASTASES TO CENTRAL NERVOUS SYSTEM  1  0/63 (0.00%)  0 1/63 (1.59%)  1
METASTASES TO LIVER  1  0/63 (0.00%)  0 1/63 (1.59%)  1
METASTASES TO LYMPH NODES  1  1/63 (1.59%)  1 0/63 (0.00%)  0
METASTASIS  1  1/63 (1.59%)  1 0/63 (0.00%)  0
METASTATIC MALIGNANT MELANOMA  1  0/63 (0.00%)  0 1/63 (1.59%)  1
NEOPLASM  1  1/63 (1.59%)  1 0/63 (0.00%)  0
Nervous system disorders     
CONVULSION  1  1/63 (1.59%)  1 1/63 (1.59%)  1
HEADACHE  1  0/63 (0.00%)  0 1/63 (1.59%)  2
HEMIPLEGIA  1  1/63 (1.59%)  2 0/63 (0.00%)  0
LETHARGY  1  0/63 (0.00%)  0 1/63 (1.59%)  1
PARAPARESIS  1  0/63 (0.00%)  0 1/63 (1.59%)  1
Psychiatric disorders     
AGITATION  1  1/63 (1.59%)  1 0/63 (0.00%)  0
CONFUSIONAL STATE  1  1/63 (1.59%)  1 0/63 (0.00%)  0
DEPRESSION  1  1/63 (1.59%)  1 0/63 (0.00%)  0
Skin and subcutaneous tissue disorders     
RASH ERYTHEMATOUS  1  0/63 (0.00%)  0 1/63 (1.59%)  1
SWEAT GLAND DISORDER  1  1/63 (1.59%)  1 0/63 (0.00%)  0
Surgical and medical procedures     
ABSCESS DRAINAGE  1  0/63 (0.00%)  0 1/63 (1.59%)  1
ORCHIDECTOMY  1  1/63 (1.59%)  1 0/63 (0.00%)  0
Vascular disorders     
CIRCULATORY COLLAPSE  1  1/63 (1.59%)  1 0/63 (0.00%)  0
1
Term from vocabulary, MedDRA 10.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PEG-Intron INTRON A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   61/63 (96.83%)      60/63 (95.24%)    
Blood and lymphatic system disorders     
LEUKOPENIA  1  7/63 (11.11%)  20 2/63 (3.17%)  2
NEUTROPENIA  1  4/63 (6.35%)  5 1/63 (1.59%)  4
THROMBOCYTOPENIA  1  4/63 (6.35%)  6 1/63 (1.59%)  5
Ear and labyrinth disorders     
VERTIGO  1  7/63 (11.11%)  24 4/63 (6.35%)  22
Eye disorders     
EYE PAIN  1  5/63 (7.94%)  13 5/63 (7.94%)  7
Gastrointestinal disorders     
ABDOMINAL PAIN  1  12/63 (19.05%)  18 3/63 (4.76%)  4
ABDOMINAL PAIN UPPER  1  6/63 (9.52%)  9 7/63 (11.11%)  8
CONSTIPATION  1  5/63 (7.94%)  10 9/63 (14.29%)  10
DIARRHOEA  1  21/63 (33.33%)  65 15/63 (23.81%)  26
DRY MOUTH  1  10/63 (15.87%)  36 15/63 (23.81%)  23
DYSPEPSIA  1  1/63 (1.59%)  1 4/63 (6.35%)  4
NAUSEA  1  29/63 (46.03%)  89 27/63 (42.86%)  57
VOMITING  1  20/63 (31.75%)  79 13/63 (20.63%)  21
General disorders     
ASTHENIA  1  22/63 (34.92%)  47 15/63 (23.81%)  31
CHILLS  1  24/63 (38.10%)  56 32/63 (50.79%)  76
FATIGUE  1  26/63 (41.27%)  186 28/63 (44.44%)  54
INFLUENZA LIKE ILLNESS  1  14/63 (22.22%)  53 11/63 (17.46%)  39
INJECTION SITE ERYTHEMA  1  10/63 (15.87%)  40 1/63 (1.59%)  1
INJECTION SITE PAIN  1  5/63 (7.94%)  6 1/63 (1.59%)  3
INJECTION SITE REACTION  1  5/63 (7.94%)  7 0/63 (0.00%)  0
MALAISE  1  6/63 (9.52%)  6 4/63 (6.35%)  8
OEDEMA PERIPHERAL  1  4/63 (6.35%)  4 5/63 (7.94%)  5
PAIN  1  11/63 (17.46%)  77 8/63 (12.70%)  11
PYREXIA  1  36/63 (57.14%)  211 30/63 (47.62%)  65
Infections and infestations     
BRONCHITIS  1  4/63 (6.35%)  4 1/63 (1.59%)  1
INFLUENZA  1  4/63 (6.35%)  4 3/63 (4.76%)  4
NASOPHARYNGITIS  1  5/63 (7.94%)  11 4/63 (6.35%)  6
Investigations     
BODY TEMPERATURE INCREASED  1  13/63 (20.63%)  15 10/63 (15.87%)  11
HEPATIC ENZYME INCREASED  1  1/63 (1.59%)  1 4/63 (6.35%)  4
TRANSAMINASES INCREASED  1  0/63 (0.00%)  0 4/63 (6.35%)  6
WEIGHT DECREASED  1  7/63 (11.11%)  9 5/63 (7.94%)  5
Metabolism and nutrition disorders     
ANOREXIA  1  23/63 (36.51%)  51 15/63 (23.81%)  20
DECREASED APPETITE  1  6/63 (9.52%)  7 7/63 (11.11%)  10
Musculoskeletal and connective tissue disorders     
ARTHRALGIA  1  15/63 (23.81%)  52 4/63 (6.35%)  6
BACK PAIN  1  20/63 (31.75%)  81 15/63 (23.81%)  22
MUSCULAR WEAKNESS  1  1/63 (1.59%)  1 5/63 (7.94%)  11
MUSCULOSKELETAL PAIN  1  4/63 (6.35%)  8 0/63 (0.00%)  0
MYALGIA  1  28/63 (44.44%)  99 28/63 (44.44%)  52
NECK PAIN  1  4/63 (6.35%)  6 2/63 (3.17%)  2
PAIN IN EXTREMITY  1  14/63 (22.22%)  47 11/63 (17.46%)  17
Nervous system disorders     
DIZZINESS  1  17/63 (26.98%)  62 8/63 (12.70%)  10
DYSGEUSIA  1  8/63 (12.70%)  13 10/63 (15.87%)  10
HEADACHE  1  39/63 (61.90%)  231 33/63 (52.38%)  83
LETHARGY  1  8/63 (12.70%)  24 5/63 (7.94%)  7
PARAESTHESIA  1  4/63 (6.35%)  8 5/63 (7.94%)  5
SOMNOLENCE  1  2/63 (3.17%)  2 4/63 (6.35%)  4
Psychiatric disorders     
DEPRESSED MOOD  1  4/63 (6.35%)  5 1/63 (1.59%)  1
DEPRESSION  1  16/63 (25.40%)  22 11/63 (17.46%)  16
INSOMNIA  1  9/63 (14.29%)  25 10/63 (15.87%)  17
SLEEP DISORDER  1  5/63 (7.94%)  6 2/63 (3.17%)  2
Respiratory, thoracic and mediastinal disorders     
COUGH  1  11/63 (17.46%)  21 7/63 (11.11%)  9
DYSPNOEA  1  7/63 (11.11%)  15 9/63 (14.29%)  16
EPISTAXIS  1  4/63 (6.35%)  6 2/63 (3.17%)  3
OROPHARYNGEAL PAIN  1  5/63 (7.94%)  5 2/63 (3.17%)  3
Skin and subcutaneous tissue disorders     
ALOPECIA  1  14/63 (22.22%)  19 11/63 (17.46%)  11
ECZEMA  1  5/63 (7.94%)  11 0/63 (0.00%)  0
ERYTHEMA  1  5/63 (7.94%)  10 0/63 (0.00%)  0
HYPERHIDROSIS  1  3/63 (4.76%)  9 10/63 (15.87%)  11
PRURITUS  1  6/63 (9.52%)  14 2/63 (3.17%)  2
RASH  1  6/63 (9.52%)  10 3/63 (4.76%)  6
Vascular disorders     
HYPOTENSION  1  4/63 (6.35%)  5 1/63 (1.59%)  1
1
Term from vocabulary, MedDRA 10.0
Indicates events were collected by systematic assessment
The study was closed to enrollment prematurely due to sub-optimal accrual. Adverse event preferred terms were converted from WHO-ART dictionary to the MedDRA version 10.0.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Principal Investigator agrees not to publish or publicly present any interim results of the Protocol study without the prior written consent of the Sponsor. The Principal Investigator further agrees to provide to the Sponsor thirty (30) days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the Protocol study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03552549     History of Changes
Other Study ID Numbers: C98135
MK-4031-002 ( Other Identifier: Merck Protocol Number )
C98-135 ( Other Identifier: Schering-Plough Protocol Number )
First Submitted: May 29, 2018
First Posted: June 12, 2018
Results First Submitted: March 29, 2019
Results First Posted: July 24, 2019
Last Update Posted: July 24, 2019