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

Roche

Status and phase: Completed; Phase 3; Phase 2

Conditions: Malignant Melanoma; Chronic Myelogenous Leukemia; Renal Cell Carcinoma

Treatments: Drug: Recombinant Interferon Alfa 2a; Drug: Pegylated Interferon Alfa-2a

Study type: Interventional

Funder types: Industry

Identifiers

NCT02829775

2004-002093-30 (EudraCT Number)

NO17754

Details and patient eligibility

About

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).

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Interferon Alfa-2A in Cancer Participants

Experimental group

Description:

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).

Treatment:

Drug: Pegylated Interferon Alfa-2a

Drug: Recombinant Interferon Alfa 2a