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)

NCT03552549 | Terminated Phase 2 Results

• 3 other identifiers: C98135MK-4031-002C98-135
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase II/III randomized, controlled, multicenter, open-label study designed to assess the safety, efficacy, and impact on quality of life of PEG Intron (MK-4031) and INTRON® A (MK-2958) and the pharmacokinetics of PEG Intron when given as adjuvant (after surgery) therapy in participants with resected (surgically removed) Stage III node-positive cutaneous melanoma.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  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.

  From time of randomization to time of progression or death (up to approximately 26 months)

Secondary Outcomes (1)

• Overall Survival

  From time of randomization to time of death (up to approximately 26 months)

Study Arms (2)

PEG-Intron

EXPERIMENTAL

Participants with stage III node positive cutaneous melanoma will receive subcutaneous PEG-Intron (6.0 ug/kg weekly) for 2 years post-surgery.

Biological: PEG-Intron

INTRON A

EXPERIMENTAL

Participants with stage III node positive cutaneous melanoma will receive 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 48 weeks post-surgery.

Biological: INTRON A

Interventions

PEG-Intron BIOLOGICAL

Polyethylene glycol (PEG)12000 Interferon alfa 2-b subcutaneous injection.

Also known as: peginterferon alfa-2b, SCH 54031, MK-4031

PEG-Intron

INTRON A BIOLOGICAL

Interferon alfa-2b, recombinant for intravenous injection.

Also known as: interferon alfa-2b, SCH 30500, MK-2958

INTRON A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have histologically documented primary cutaneous melanoma meeting one of the following staging criteria:
• Primary melanoma of any stage in the presence of N1 regional lymph node metastases detected at elective lymph node dissection or sentinel node biopsy, with clinically inapparent regional lymph node metastasis (any pTN1M0).
• Clinically apparent N1 or N2a regional lymph node involvement synchronous with primary melanoma of T1-4 (any pTN1-2aM0).
• Regional lymph node recurrence at any interval after appropriate surgery for primary melanoma of any depth (any primary tumor \[pT\], r N1-2a M0).
• Participants must have had all known disease completely resected with adequate surgical margins within 56 days prior to randomization into the study
• Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Participants must have adequate hepatic, renal and bone marrow function as defined by the following parameters obtained within 14 days prior to initiation of study treatment:
• Hematology: white blood cells (WBC) ≥3,000 cells/µL and hemoglobin ≥9 g/dL.
• Renal and hepatic function: serum creatinine \<2.0 mg/dL; aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) \<2 times upper limit of laboratory normal (ULN); and serum bilirubin \<2 times ULN
• Participants must sign and date a voluntary informed consent form before study entry, be willing to participate in this study and agree to complete all follow-up assessments.

You may not qualify if:

• Participants who have received any prior chemotherapy, immunotherapy hormonal or radiation therapy for melanoma.
• Participants who have evidence of distant or non-regional lymph node metastases, in-transit metastases, or positive lymph nodes with an unknown primary.
• Participants whose disease cannot be completely surgically resected because of gross extracapsular extension.
• Participants who have previously received interferon for any reason.
• Participants who have severe cardiovascular disease, i.e., arrhythmias requiring chronic treatment, congestive heart failure (New York Heart Association \[NYHA\] Class III or IV) or symptomatic ischemic heart disease.
• Participants who have a history of neuropsychiatric disorder requiring hospitalization.
• Participants with thyroid dysfunction not responsive to therapy.
• Participants with uncontrolled diabetes mellitus.
• Participants with a history of prior malignancy within the past 5 years other than surgically cured non-melanoma skin cancer or cervical carcinoma in situ.
• Participants who have a history of seropositivity for human immunodeficiency virus (HIV).
• Participants who are pregnant, lactating, or of reproductive potential and not practicing an effective means of contraception.
• Participants with active and/or uncontrolled infection, including active hepatitis.
• Participants with a medical condition requiring chronic systemic corticosteroids.
• Participants who are known to be actively abusing alcohol or drugs.
• Participants who have received any experimental therapy within 30 days prior to randomization in this study.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Melanoma

Interventions

peginterferon alfa-2b; Introns; Interferon alpha-2

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes; Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Limitations and Caveats

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.

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 12, 2018
• Study Start: August 5, 1998
• Primary Completion: February 19, 2001
• Study Completion: February 19, 2001
• Last Updated: July 24, 2019
• Results First Posted: July 24, 2019

Record last verified: 2019-07