The purpose of this study is to test the effectiveness, safety, and tolerability of an investigational drug called nivolumab in subjects with early stage (IIB/C) melanoma that have had their tumors completely removed, but could possibly have their cancer return.
Nivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. OPDIVO® (nivolumab) is approved for the treatment of certain types of cancer including the skin, kidney, blood, and lung in multiple countries including the United States (US, Dec-2014), the European Union (EU, Jun-2015), and Japan (Jul-2014). Opdivo® is also approved for use in patients after complete surgical removal of melanoma that has spread to either the local/regional lymph nodes or other distant areas of the body. As nivolumab is not yet approved by the U.S. Food and Drug Administration (FDA) in early stage (IIB/C) melanoma, positive results from this research study may help gain approval in this patient population.
Inova Schar Cancer Institute
8081 Innovation Park Dr.
Fairfax, VA 22031
A department of Inova Fairfax Hospital
- Adults over the ages of 18
- Participants must have been diagnosed with stage IIB/C cutaneous melanoma and have histologically confirmed melanoma that is completely surgically resected, with documented negative margins (per local standard) for disease on resected specimens. All melanomas, except ocular/uveal and mucosal melanoma, regardless of primary site of disease will be allowed.
- Participants must have a negative sentinel lymph node biopsy. Participants in whom a sentinel lymph node biopsy procedure could not be done or a sentinel lymph node was not detected are not eligible
- Participant has not been previously treated for melanoma beyond complete surgical resection of the melanoma lesion
- Participant has recovered adequately from toxicity and/or complications from surgery prior to study start
- ECOG performance status of 0 or 1 at the time of enrollment
- Participants must be able and willing to comply with the study visit schedule and study procedures
- Additional eligibility in protocol.
- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study treatment
- Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with study treatment(s) for a total of 5 months after the last dose of study treatment
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for a total of 7 months post-treatment completion. In addition, male participants must be willing to refrain from sperm donation during this time. Azoospermic males are exempt from contraceptive requirements unless the potential exists for fetal toxicity due to study drug being present in seminal fluid, even if the participant has undergone a successful vasectomy or if the partner is pregnant. WOCBP who are continuously not heterosexually active are also exempt from contraceptive requirements, and still must undergo pregnancy testing as described in this section.
- Additional ineligibility in protocol
Additional information can be found at: https://clinicaltrials.gov/ct2/show/NCT04099251