A Study of Continued Treatment Among Participants Who Have Responded to Peginterferon Alfa-2a (Pegasys®) or Recombinant Interferon Alfa-2a (Roferon-A®) in Prior Clinical Studies

Study Overview
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Brief Summary
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This open label extension study will give an opportunity to the participants that have responded to the treatment with Pegylated-Interferon Alfa-2a (Pegasys) or Recombinant Interferon Alfa-2a (Roferon-A®) in prior clinical studies NO15753 (NCT00003542) for Renal Cell Carcinoma (RCC), NO15764 (NCT number not available) and NO16006 (NCT02736721) for Chronic Myelogenous Leukemia (CML), and NO16007 (NCT number not available) for Malignant Melanoma (MM).

Official Title
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Extension Protocol for Patients With Chronic Myelogenous Leukemia, Malignant Melanoma or Renal Cell Carcinoma That Have Responded to Treatment With Pegylated-Interferon α-2a or Roferon-A® in Prior Clinical Studies

Conditions
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Chronic Myelogenous Leukemia, Malignant Melanoma, Renal Cell Carcinoma

Intervention / Treatment
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* Drug: Pegylated Interferon Alfa-2a
* Drug: Recombinant Interferon Alfa 2a


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must have completed protocol NO15753, NO15764, NO16006 or NO16007 and responded to treatment at the end of the trial as defined in the parent protocol CML participants must have a confirmed cytogenetic complete response within 2 months of entering the extension study. MM and RCC participants must have tumour assessments verifying stable or better response within 2 months of entering the extension study Exclusion Criteria: Pregnant or lactating women Refusal to use adequate contraceptive measures among men and women of childbearing potential

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interferon Alfa-2A in Cancer Participants<br>Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study will continue to receive the same treatment in this study. Pegylated interferon alfa-2A will be administered subcutaneously once weekly and recombinant interferon alfa 2A will be administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurs first (up to approximately 3 years). | Drug: Pegylated Interferon Alfa-2a<br>* Participants will maintain the same dose they were receiving in the parent protocol.<br>* Other names: Pegasys;Drug: Recombinant Interferon Alfa 2a<br>* Participants will maintain the same dose they were receiving in the parent protocol.<br>* Other names: Roferon-A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Serious Adverse Events (SAEs) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship to the study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; Life-threatening experience (immediate risk of dying); Persistent or significant disability or incapacity; and congenital anomaly. | Baseline up to approximately 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Overall Tumor Response | Tumor response was assessed every 6 months using hematological evaluation or any other appropriate diagnostic techniques, as per standard of care practice. The complete response (CR) and partial response (PR) status were recorded from case report form. | Baseline until disease progression, withdrawal or death, whichever occurred earlier (assessed every 6 months up to approximately 3 years) |