Adjuvant Treatment Determined By Pathological Response To Neoadjvuant Nivolumab

2019-07-16 10:39:02 | BioPortfolio


Subjects with resectable melanoma will receive neoadjuvant nivolumab followed by surgical resection. Post-operatively, subjects will receive open-label treatment with up to 1 year of adjuvant nivolumab or ipilimumab plus nivolumab as determined by pathologic response at the time of resection.


Subjects with Stage III resectable melanoma will receive one dose of nivolumab 480 mg IV, then undergo standard definitive surgery approximately 4 weeks after the initial dose of nivolumab. Post-operatively, subjects will receive open-label treatment with up to 1 year of adjuvant nivolumab 480 mg IV every 4 weeks or ipilimumab plus nivolumab, as determined by pathologic response at the time of resection. Subjects with pathologic complete response or near pathologic complete response (PathCR/nearCR) (Arm A) receive adjuvant nivolumab for up to one year. Subjects with

Study Design


Melanoma Stage III


nivolumab, Ipilimumab


Abramson Cancer Center, University of Pennsylvania
United States


Not yet recruiting


Abramson Cancer Center of the University of Pennsylvania

Results (where available)

View Results


Published on BioPortfolio: 2019-07-16T10:39:02-0400

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Medical and Biotech [MESH] Definitions

An anti-CTLA-4 ANTIGEN monoclonal antibody initially indicated for the treatment of certain types of metastatic MELANOMA. Its mode of actions may include blocking of CTLA-4 mediated inhibition of CYTOTOXIC T LYMPHOCYTES, allowing for more efficient destruction of target tumor cells.

A melanosome-specific protein that plays a role in the expression, stability, trafficking, and processing of GP100 MELANOMA ANTIGEN, which is critical to the formation of Stage II MELANOSOMES. The protein is used as an antigen marker for MELANOMA cells.

An unpigmented malignant melanoma. It is an anaplastic melanoma consisting of cells derived from melanoblasts but not forming melanin. (Dorland, 27th ed; Stedman, 25th ed)

Experimentally induced tumor that produces MELANIN in animals to provide a model for studying human MELANOMA.

A cellular subtype of malignant melanoma. It is a pigmented lesion composed of melanocytes occurring on sun-exposed skin, usually the face and neck. The melanocytes are commonly multinucleated with a "starburst" appearance. It is considered by many to be the in situ phase of lentigo maligna melanoma.

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