Study on Nivolumab vs. Placebo for Preventing Melanoma from Returning After Surgery
Sponsor: Bristol-Myers Squibb
Sponsor score: 60
ClinicalTrials ID:NCT04099251
This clinical trial is testing whether the drug nivolumab can help prevent melanoma from coming back after surgery in patients who have had Stage IIB/C melanoma completely removed.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The aim of this study is to find out if using the immunotherapy drug nivolumab can effectively prevent the return of melanoma in adults and children who have had Stage IIB/C melanoma completely removed and currently show no signs of the disease. These patients are considered at high risk for the cancer coming back.
Eligibility Criteria
Inclusion Criteria
- Must have had a negative sentinel lymph node biopsy, meaning no cancer was found in the lymph nodes.
- Must not have received any previous treatment for melanoma.
- Must be in good overall health with an ECOG performance status of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Must have been diagnosed with Stage IIB/C melanoma that has been completely removed by surgery.
Exclusion Criteria
- Cannot have a history of melanoma in the eye or mucous membranes.
- Cannot be pregnant or breastfeeding.
- Cannot have an active autoimmune disease or one that is suspected.
- Cannot have a known allergy to any components of the study drug.
- Cannot have had previous treatments with certain immune system-targeting drugs, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibodies, or drugs targeting IL-2 pathways, T-cell stimulators, or checkpoint pathways.
Other specific criteria may apply as defined by the study protocol.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Local Institution - 0088 | 35294-3300 | Birmingham | Alabama |
| Local Institution - 0126 | 85724-5024 | Tucson | Arizona |
| Local Institution - 0087 | 72762 | Springdale | Arkansas |
| Local Institution - 0080 | 90025 | Los Angeles | California |
| Local Institution - 0077 | 94115 | San Francisco | California |
| Local Institution - 0119 | 94115 | San Francisco | California |
| Local Institution - 0122 | 95119 | San Jose | California |
| Local Institution - 0121 | 94589-2441 | Vallejo | California |
| Local Institution - 0109 | 94589 | Vallejo | California |
| Local Institution - 0120 | 94589 | Vallejo | California |
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