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A Study of Pegylated Interferon Alfa-2b (MK-4031) as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (MK-4031-370)
Phase 1 trial testing PegIFN alfa-2b in Malignant Melanoma in 9 participants. Terminated before completion.
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 25 December 2012 |
| Primary completion | 26 March 2014 |
| Estimated completion | 4 November 2015 |
Merck Sharp & Dohme LLC — full company profile →
Adults 20 to 75, any sex, with Malignant Melanoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
A DLT was an event (clinical or laboratory) that resulted in a change in the given dose.
| Group | Value | 95% CI |
|---|---|---|
| Participants Receiving PegIFN Alfa-2b | 2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Participants Receiving PegIFN Alfa-2b | 9 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Participants Receiving PegIFN Alfa-2b | 5 |
Time frame: From first dose through follow-up; up to 265 Weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Participants Receiving Peg… |
|---|---|---|
| Pyrexia | General disorders | — |
| Neutrophil count decreased | Investigations | — |
| White blood cell count decreased | Investigations | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Aspartate aminotransferase increased | Investigations | — |
| Nausea | Gastrointestinal disorders | — |
| Chills | General disorders | — |
| Injection site reaction | General disorders | — |
| Malaise | General disorders | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Fatigue | General disorders | — |
| Platelet count decreased | Investigations | — |
| Weight decreased | Investigations | — |
| Headache | Nervous system disorders | — |
| Upper respiratory tract infection | Infections and infestations | — |
| Decreased appetite | Metabolism and nutrition disorders | — |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | — |
| Alopecia | Skin and subcutaneous tissue disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Stomatitis | Gastrointestinal disorders | — |
| Injection site erythema | General disorders | — |
| Injection site pruritus | General disorders | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Conjunctivitis | Infections and infestations | — |
| Punctate keratitis | Eye disorders | — |
| Retinopathy | Eye disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Gamma-glutamyltransferase increased | Investigations | — |
| Lymphocyte count decreased | Investigations | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — |
| Hypoalbuminaemia | Metabolism and nutrition disorders | — |
| Hypocalcaemia | Metabolism and nutrition disorders | — |
| Dizziness | Nervous system disorders | — |
| Insomnia | Psychiatric disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — |
| Influenza like illness | General disorders | — |
Data from ClinicalTrials.gov NCT01636960 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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