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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