Phase I study of ipilimumab combined with whole brain radiation therapy or radiosurgery for melanoma patients with brain metastases

We initiated a phase I study to determine the maximum tolerable dose and toxicity of ipilimumab concurrently with radiotherapy in patients with brain metastases from melanoma. Based on burden of intracranial disease, patients were treated with WBRT or SRS with concurrent ipilimumab (3 mg/kg with escalation to 10 mg/kg). Ipilimumab 10 mg/kg with SRS was safe. The WBRT arm with ipilimumab 10 mg/kg closed early secondary to slow accrual. There were no grade 4/5 toxicities.

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