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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Nivolumab and Ipilimumab in Estimating Anti-Tumor Activity and Identifying Potential Predictors of Response in Patients with Melanoma That is Metastatic or Cannot Be Removed by Surgery

This phase II trial studies how well nivolumab and ipilimumab work in estimating anti-tumor activity and identifying potential predictors of response in patients with melanoma that is spreading to other places in the body or that cannot be removed by surgery. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread.
Melanoma
N/A
Both
Not Available
Not Available
Johnson, Douglas
National
Vanderbilt University
08-10-2018
Other
VICCMEL1816
NCT02978443

Eligibility

0 Years
BOTH
NO
Inclusion Criteria:

Patients must have histologically confirmed MCM or ALM that is metastatic or unresectable

Patients must have measurable disease and be eligible to receive nivolumab in combination with ipilimumab treatment per institutional guidelines

Patients must have a tissue block (or 26 unstained slides) available with adequate tumor to perform multiplex immunohistochemistry and nucleic acids analyses (i.e. whole exome sequencing); patients with only a previous fine-needle aspirate are ineligible for enrollment

Patients must be willing to donate a small amount of whole blood prior to treatment and during treatment for laboratory analysis

Patients must give informed consent prior to initiation of therapy

Patients must be ambulatory with good performance status (Eastern Cooperative Oncology Group [ECOG] 0 or 1)



Exclusion Criteria:

Patients who do not have available tissue for immunohistochemistry and nucleic acids analyses

Patients who have received prior immunotherapy for unresectable or metastatic disease

Patients with evidence of active brain metastases, or active leptomeningeal disease are ineligible; patients with a history of brain metastases must have completed treatment (i.e. surgery or radiation) prior to enrollment

Patients with inadequate tissue for analysis

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