Clinical Trial for Patients Following Complete Resection (removal) of Melanoma
The Inventa Center for Cancer Research at Fort Wayne Medical Oncology is one of only four locations in the USA seeking qualified men and women age 18+ to participate in clinical trial CA209-6GE.
The purpose of this study is to compare the drug levels of nivolumab administered subcutaneously (under the skin) versus intravenous administration in participants with melanoma following complete resection (surgery to remove the cancer).
We encourage you to discuss this study your current doctor or call FWMOH 260-484-8830 to see if you may be eligible to participate.
What Is Novolumab?
Nivolumab is a type of cancer treatment drug called an immunotherapy. It works by preventing cancer cells from blocking your body’s own immune system and is approved for use against several forms of cancer.
See our Clinical Trial FAQ’s to learn more about participating in a study.
To be eligible you must meet these criteria:
- Stage IIIA/B/C/D or Stage IV melanoma and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins
- Complete resection performed within 12 weeks prior to randomization or treatment assignment
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
You are ineligible if you have:
- History of uveal or mucosal melanoma
- Untreated/unresected CNS metastases or leptomeningeal metastases
- Active, known or suspected autoimmune disease
- Serious or uncontrolled medical disorder 4 weeks prior to screening
- Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization or treatment assignment. Participants with history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are eligible
- Prior immunotherapy treatments for any prior malignancies are not permitted
- There may be additional inclusion/exclusion criteria that apply.
