MelanomaPhase 2NCT02155322
A Phase II Study of Pegylated Interferon Alfa-2b for the Adjuvant Treatment of Melanoma Subjects in Russia (MK-4031-400)
A Phase 2 study testing Pegylated Interferon Alfa-2b in people with Melanoma, run by Merck Sharp & Dohme LLC.
Trial summary
This study will assess the safety of Pegylated Interferon Alfa-2b (PEG-IFN) as an adjuvant treatment for melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Pegylated Interferon Alfa-2b
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 19 Aug 2014to 21 Mar 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Competent to self-administer the subcutaneous injections of PEG-IFN
- Histologically documented involved regional lymph nodes of a primary cutaneous melanoma or unknown primary, meeting the study's staging criteria
- Had the primary melanoma completely resected with adequate surgical margins and undergone operation for positive regional lymph nodes within 84 days of study start
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
- Adequate hepatic, renal and bone marrow function as defined by study parameters obtained within 4 weeks prior to study start
- For a female subject who is of childbearing potential or male participant with female sexual partner who is of childbearing potential, agree to use acceptable methods of contraception for at least 2 weeks prior to study start and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations
Who cannot join
- Mucous membrane melanoma or ocular melanoma
- Known hypersensitivity to the components of study drug (including acetaminophen), or its analogs
- Evidence of distant or non-regional lymph node metastases or in-transit metastases
- Disease that cannot be completely surgically resected
- Prior malignancy within the past 5 years other than surgically cured non-melanoma skin cancer or cervical carcinoma in situ
- Severe cardiovascular disease, i.e. arrhythmias, requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease
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- Hepatic decompensation
- Thyroid dysfunction not responsive to therapy
- Uncontrolled diabetes mellitus
- Clinically active autoimmune disease
- Clinically active and/or uncontrolled infection, including active hepatitis
- Human immunodeficiency virus (HIV)
- History of neuropsychiatric disorder requiring hospitalization
- Actively abusing alcohol or drugs
- Pregnant, lactating, or of reproductive potential and not using an effective means of contraception
- Medical condition requiring chronic systemic corticosteroids
- Received any experimental therapy within 30 days prior to enrolling in this study
- Received any prior chemotherapy, immunotherapy, hormonal or radiation therapy for melanoma
- Previously received interferon-α for any reason
- Known serious hypersensitivity reaction to PEG-IFN or interferon alfa-2b
About this study
Official title: A Phase II Study of Pegylated Interferon Alfa-2b in AJCC Stage III (TxN1-2M0) Melanoma Subjects After Regional Lymph Node Dissection in Russia
This study will assess the safety of Pegylated Interferon Alfa-2b (PEG-IFN) as an adjuvant treatment for melanoma.
- Conditions
- Melanoma
- Being tested
- Pegylated Interferon Alfa-2b
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated Interferon Alfa-2bBiological
6 μg/kg, weekly dosing, subcutaneous administration, Induction Phase - first 8 weeks
Pegylated Interferon Alfa-2bBiological
3 μg/kg SC once weekly for a 42-week maintenance phase (for a total treatment of up to approximately 1 year)
| Study group | Role | What they receive |
|---|---|---|
| PEG-IFN | Experimental | 6.0 μg/kg/week subcutaneous administration during the Induction Phase of 8 weeks followed by a dose of 3.0 μg/kg/week subcutaneous administration in the Maintenance Period (Week 8 to Month 12) Receives: Biological: Pegylated Interferon Alfa-2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage 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.
Measured: From first dose through follow-up; up to 13 months
Percentage 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.
Measured: From first dose to last dose of treatment; up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study start19 Aug 2014
- Primary completion21 Mar 2016
- Study completion21 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155322
- Sponsor's protocol ID
- 4031-400
- Status last verified
- Jul 2018
- First submitted
- 2 Jun 2014
- Last updated
- 23 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Pegylated Interferon Alfa-2b in AJCC Stage III (TxN1-2M0) Melanoma Subjects After Regional Lymph Node Dissection in Russia
- ClinicalTrials.gov ID
- NCT02155322
- Acronym / sponsor ID
- 4031-400
- Conditions
- Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2014 (actual)
- Primary completion
- 21 Mar 2016 (actual)
- Study completion
- 21 Mar 2016 (actual)
- First posted
- 4 Jun 2014 (estimated)
- Results
- Posted 11 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety of Pegylated Interferon Alfa-2b (PEG-IFN) as an adjuvant treatment for melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEG-IFN | Experimental | Biological: Pegylated Interferon Alfa-2b6.0 μg/kg/week subcutaneous administration during the Induction Phase of 8 weeks followed by a dose of 3.0 μg/kg/week subcutaneous administration in the Maintenance Period (Week 8 to Month 12) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Competent to self-administer the subcutaneous injections of PEG-IFN
- Histologically documented involved regional lymph nodes of a primary cutaneous melanoma or unknown primary, meeting the study's staging criteria
- Had the primary melanoma completely resected with adequate surgical margins and undergone operation for positive regional lymph nodes within 84 days of study start
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
- Adequate hepatic, renal and bone marrow function as defined by study parameters obtained within 4 weeks prior to study start
Key exclusion criteria (20 listed)
- Mucous membrane melanoma or ocular melanoma
- Known hypersensitivity to the components of study drug (including acetaminophen), or its analogs
- Evidence of distant or non-regional lymph node metastases or in-transit metastases
- Disease that cannot be completely surgically resected
- Prior malignancy within the past 5 years other than surgically cured non-melanoma skin cancer or cervical carcinoma in situ
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pegylated Interferon Alfa-2b6 μg/kg, weekly dosing, subcutaneous administration, Induction Phase - first 8 weeks | Biological | PEG-IFN |
| Pegylated Interferon Alfa-2b3 μg/kg SC once weekly for a 42-week maintenance phase (for a total treatment of up to approximately 1 year) | Biological | PEG-IFN |
Primary outcome
Percentage of Participants Experiencing Adverse Events (AEs)
Time frame: From first dose through follow-up; up to 13 months
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.
Percentage of Participants Discontinuing Study Drug Because of AEs
Time frame: From first dose to last dose of treatment; up to 12 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pegylated Interferon Alfa-2b in people with Melanoma, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Experiencing Adverse Events (AEs) (time frame: From first dose through follow-up; up to 13 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2018.