A Phase II Study of Ipilimumab and Nivolumab Combination Immunotherapy in Patients with Advanced Mucosal and Acral Lentiginous Melanoma

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Full Title

MRFBC (CA209-763): A Study to Estimate the Anti-Tumor Activity and Identify Potential Predictors of Response in Patients with Advanced Mucosal or Acral Lentiginous Melanoma Receiving Standard Nivolumab in Combination with Ipilimumab Followed by Nivolumab Monotherapy

Purpose

The purpose of this study is to assess the effectiveness of immunotherapy with nivolumab and ipilimumab in patients with advanced mucosal or acral lentiginous melanoma. Researchers also want to see if they can find markers in tumors, the blood, or the stool that may be used to predict a patient’s response to this combination therapy.

Ipilimumab and nivolumab are used together to treat melanoma of the skin. Both work by enhancing the ability of the immune system to find and destroy cancer cells. They are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic or inoperable mucosal or acral lentiginous melanoma.
  • Prior treatment with dabrafenib plus trametinib or vemurafenib plus cobimetinib is permitted, but patients may not have received PD-1 inhibitors (such as nivolumab) or CTLA-4 inhibitors (such as ipilimumab).
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Alexander Shoushtari at 646-888-4161.

Protocol

19-009

Phase

II

Co-Investigators

Diseases