Melanoma Clinical Trial
Official title:
Phase II Study of CTLA-4 Blockade and Low Dose Cyclophosphamide in Patients With Advanced Malignant Melanoma
The purpose of this study is to see whether the combination of low-dose Cyclophosphamide and Anti-CTLA4 (Ipilimumab) will stop tumor growth in patients with advanced skin cancer. The investigators expect to see an increase in response rate of the combination over Anti-CTLA-4 alone and estimate a response rate of approximately 20 % in the proposed population.
The transient removal of CTLA-4-mediated inhibition (CTLA-4 blockade) can induce effective
anti-tumor immunity. Efficacy of CTLA-4 blockade as a single agent has been shown in melanoma
53. It has been hypothesized that anti-CTLA-4 antibody might deplete Treg cells 54, inducing
autoimmunity. However, patients receiving Ipilimumab have not shown a decrease in Treg number
or function in peripheral blood 55.
This trial will answer the question if the combination of Anti-CTLA 4 (following a well
established regimen of Ipilimumab) and Cyclophosphamide (given at immunomodulatory doses)
will result in antitumor activity in patients with metastatic melanoma due to synergistic
immunomodulating effects by overcoming tolerance.
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