A Phase II Study of Nivolumab with Ipilimumab and Cabozantinib in Patients with Untreated Renal Cell Carcinoma Brain Metastases
Signed Informed Consent Form (ICF)
Ability and willingness to comply with the requirements of the study protocol
Age ≥18 years
Life expectancy >12 weeks
Symptomatic brain metastases requiring immediate local interventions such as craniotomy or SRS or whole brain radiation.
Patients who require immediate surgical or radiotherapy interventions for extra-cranial lesions.
Radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
Requiring corticosteroid dose in 10 days prior to administration of first dose of study drug with following exceptions
Single group
Nivolumab
DrugGiven by IV
Ipilimumab
DrugGiven by IV
Cabozantinib
DrugGiven by IV
To associate if the combination of nivolumab with ipilimumab and cabozantinib produces improvesintracranial progression-free survival (PFS) in patients.
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