Dr. Pavlick on a Phase II Trial of Cyclophosphamide and Ipilimumab in Melanoma

Anna C. Pavlick, DO, associate professor, Hematology and Medical Oncology, medical director, Clinical Trials Office, Perlmutter Cancer Center at NYU Langone, discusses a phase II trial exploring low-dose cyclophosphamide and ipilimumab in metastatic melanoma.

Pavlick says it has been observed in the lab that the T regulatory cells can be regulated when melanoma cells are given low doses of cyclophosphamide. A down-regulation of these cells usually enhances an immune response.

In this phase II trial, patients were given low-dose of cyclophosphamide before receiving a checkpoint blockade with CTLA-4, Pavlick says. Researchers expected to see an enhanced immune response along with a better patient response compared to when patients receive CTLA-4 alone. However, Pavlick says, while the low-dose cyclophosphamide clearly regulated a facet of the immune system, patients’ disease became more refractory to immunotherapy.

Pavlick says the toxicity also increased in these patients. In this study, researchers saw a doubling in toxicities such as, diarrhea, rash, and itching and endocrinopathies compared with ipilimumab alone.

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