MelanomaPhase 2/3NCT03552549
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)
A Phase 2/3 study testing PEG-Intron and INTRON A in people with Melanoma, run by Merck Sharp & Dohme LLC.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Melanoma
- What is being tested?
- PEG-Intron and INTRON A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 5 Aug 1998to 19 Feb 2001
- Phase
- Phase 2/3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
- Participants who have not recovered from the effects of recent surgery.
About this study
Official title: A Randomized Phase II/III Trial of SCH 54031 PEG12000 Interferon Alfa-2b (PEG Intron) vs. INTRON®A as Adjuvant Therapy for Melanoma
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.
Read the detailed description
This study was closed to enrollment prematurely due to sub-optimal accrual. Participants who were enrolled prior to enrollment closure were allowed to continue to receive study drug; these participants were followed for safety only.
- Conditions
- Melanoma
- Being tested
- PEG-Intron, INTRON A
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-IntronBiological
Also called peginterferon alfa-2b, SCH 54031, MK-4031
Polyethylene glycol (PEG)12000 Interferon alfa 2-b subcutaneous injection.
INTRON ABiological
Also called interferon alfa-2b, SCH 30500, MK-2958
Interferon alfa-2b, recombinant for intravenous injection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: INTRON A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From time of randomization to time of progression or death (up to approximately 26 months)
Secondary outcomes (1)
Overall Survival
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.
Measured: From time of randomization to time of death (up to approximately 26 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start5 Aug 1998
- Primary completion19 Feb 2001
- Study completion19 Feb 2001
Why it stopped: This study was closed to enrollment prematurely due to sub-optimal accrual.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 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
- NCT03552549
- Sponsor's protocol ID
- C98135
- Other IDs
- MK-4031-002, C98-135
- Status last verified
- Jul 2019
- First submitted
- 29 May 2018
- Last updated
- 24 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II/III Trial of SCH 54031 PEG12000 Interferon Alfa-2b (PEG Intron) vs. INTRON®A as Adjuvant Therapy for Melanoma
- ClinicalTrials.gov ID
- NCT03552549
- Acronym / sponsor ID
- C98135
- Conditions
- Melanoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was closed to enrollment prematurely due to sub-optimal accrual.
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 1998 (actual)
- Primary completion
- 19 Feb 2001 (actual)
- Study completion
- 19 Feb 2001 (actual)
- First posted
- 12 Jun 2018 (actual)
- Results
- Posted 24 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study was closed to enrollment prematurely due to sub-optimal accrual. Participants who were enrolled prior to enrollment closure were allowed to continue to receive study drug; these participants were followed for safety only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG-Intron | Experimental | Biological: PEG-IntronParticipants with stage III node positive cutaneous melanoma will receive subcutaneous PEG-Intron (6.0 ug/kg weekly) for 2 years post-surgery. |
| INTRON A | Experimental | Biological: INTRON AParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participants must have histologically documented primary cutaneous melanoma meeting one of the following staging criteria:
- 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:
- 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.
Key exclusion criteria (16 listed)
- 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.
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 |
|---|---|---|
| PEG-IntronAlso: peginterferon alfa-2b, SCH 54031, MK-4031Polyethylene glycol (PEG)12000 Interferon alfa 2-b subcutaneous injection. | Biological | PEG-Intron |
| INTRON AAlso: interferon alfa-2b, SCH 30500, MK-2958Interferon alfa-2b, recombinant for intravenous injection. | Biological | INTRON A |
Primary outcome
Progression-free Survival (PFS)
Time frame: From time of randomization to time of progression or death (up to approximately 26 months)
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.
1 secondary outcome
Overall Survival
Time frame: From time of randomization to time of death (up to approximately 26 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 2/3 study testing PEG-Intron and INTRON A 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 10 inclusion and 16 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: stopped early, as of the sponsor's last update on 24 Jul 2019. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 24 Jul 2019). 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?
Progression-free Survival (PFS) (time frame: From time of randomization to time of progression or death (up to approximately 26 months)). 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 24 Jul 2019.