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| ID | Type | Description | Link |
|---|---|---|---|
| MK-4031-370 | Other Identifier | Merck protocol number | |
| 132228 | Registry Identifier | JAPIC-CTI |
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The study was terminated after 118 weeks from the study start, during the maintenance phase, due to regulatory approval in Japan.
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This is a study to evaluate the safety and tolerability of peginterferon alfa-2b (PegIFN alfa-2b) as adjuvant treatment in Japanese participants with malignant melanoma after definitive surgical resection including complete lymphadenectomy. Participants on this study will initially receive PegIFN alfa-2b for 8 weeks (Induction Phase) and then may continue to receive PegIFN alfa-2b (Maintenance Phase) as long as they are experiencing clinical benefit (Up to 252 weeks). The primary hypothesis is that peginterferon alfa-2b administered on a weekly basis is safe and tolerated.
The study was terminated after 118 weeks from the study start, during the maintenance phase, due to regulatory approval in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving PegIFN alfa-2b | Experimental | Participants receive 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PegIFN alfa-2b | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Dose-limiting Toxicities (DLTs) - Induction Phase | A DLT was an event (clinical or laboratory) that resulted in a change in the given dose. | From first dose to end of induction phase; up to 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Number of Participants Experiencing Adverse Events (AEs) | 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. | From first dose through follow-up; up to 265 Weeks |
| Number of Participants Discontinuing Study Drug Because of AEs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27087489 | Result | Yamazaki N, Uhara H, Wada H, Matsuda K, Yamamoto K, Shimamoto T, Kiyohara Y. Phase I study of pegylated interferon-alpha-2b as an adjuvant therapy in Japanese patients with malignant melanoma. J Dermatol. 2016 Oct;43(10):1146-1153. doi: 10.1111/1346-8138.13338. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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This study enrolled Japanese participants with Stage II or III malignant melanoma who had undergone surgical resection and lymphadenectomy.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Induction Phase |
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| ||||||||||||||||||
| Maintenance Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Experiencing Dose-limiting Toxicities (DLTs) - Induction Phase | A DLT was an event (clinical or laboratory) that resulted in a change in the given dose. | All participants in the induction phase of the study | Posted | Number | Participants | From first dose to end of induction phase; up to 8 Weeks |
|
|
From first dose through follow-up; up to 265 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
The study was terminated after 118 weeks from the study start, during the maintenance phase, due to regulatory approval in Japan.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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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. |
| From first dose to last dose of treatment; up to 260 Weeks |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Safety: Number of Participants Experiencing Adverse Events (AEs) | 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. | All participants who received at least one dose of study drug. | Posted | Number | Participants | From first dose through follow-up; up to 265 Weeks |
|
|
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| Secondary | Number of Participants Discontinuing Study Drug Because of AEs | 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. | All participants receiving at least one dose of study drug. | Posted | Number | Participants | From first dose to last dose of treatment; up to 260 Weeks |
|
|
|
| 0 |
| 9 |
| 9 |
| 9 |
| Tinnitus | Ear and labyrinth disorders | MedDRA 17.1 | Systematic Assessment |
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| Vertigo positional | Ear and labyrinth disorders | MedDRA 17.1 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Punctate keratitis | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Retinopathy | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA 17.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Periodontal disease | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Injection site extravasation | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Injection site reaction | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Adenoiditis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Gastroenteritis bacterial | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Pericoronitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
|
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 17.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Pharyngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Chalazion | Eye disorders | MedDRA 17.1 | Systematic Assessment |
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| Ocular discomfort | Eye disorders | MedDRA 17.1 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Injection site joint pain | General disorders | MedDRA 17.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Quadriplegia | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Urinary tract disorder | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
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.
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |