Study to Compare ABP 206 and OPDIVO® (Nivolumab) in Patients with Surgically Removed Melanoma
Sponsor: Amgen
ClinicalTrials ID:NCT05907122
This clinical trial is examining whether the new drug ABP 206 is similar in effectiveness and safety to OPDIVO® (Nivolumab) for patients who have had advanced melanoma surgically removed.
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Program Overview
The study aims to compare how ABP 206 and OPDIVO® (Nivolumab) work in the body, their effectiveness, safety, and how the immune system responds to them in patients with advanced melanoma that has been surgically removed.
Description
Participants in this study will be randomly assigned to one of three groups: one receiving ABP 206, another receiving the FDA-approved version of Nivolumab, and the third receiving the EU-approved version of Nivolumab. The treatment will follow the same guidelines as OPDIVO® for melanoma, continuing until the cancer returns, side effects become too severe, or the participant decides to stop, with a maximum treatment period of one year. Each participant will be involved in the study for about 13 months in total.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have had melanoma completely removed by surgery within the last 12 weeks.
- Have advanced melanoma.
- Must provide tumor tissue from the surgery for analysis.
- Must be in good general health, with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
Exclusion Criteria
- Have had previous cancer treatments.
- Have allergies to monoclonal antibodies or ingredients in the study drug.
- Have eye melanoma or a history of cancer in the brain lining.
- Have a history of autoimmune diseases.
- Require medications that suppress the immune system within 14 days before starting the study treatment.
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