NCT05048212
A Phase II Study of Nivolumab With Ipilimumab and Cabozantinib in Patients With Untreated Renal Cell Carcinoma Brain Metastases
Recruiting · Phase 2 · M.D. Anderson Cancer Center · registry updated 2026-09-18
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
A Phase II Study of Nivolumab with Ipilimumab and Cabozantinib in Patients with Untreated Renal Cell Carcinoma Brain Metastases
Inclusion
- Signed Informed Consent Form (ICF)
- Ability and willingness to comply with the requirements of the study protocol
- Age ≥18 years
- Life expectancy \>12 weeks
- Asymptomatic and off steroids for at least 10 days except patients: who have mild symptoms from intracranial disease that do not affect their performance status
- Prior therapies for extracranial metastatic renal cell carcinoma as long as it did not include anti- CTLA-4 or cabozantinib or MET inhibitors
Exclusion
- 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
- \- Symptomatic patients who have stable or decreasing corticosteroid use in the past 10 days may be included
- Patients with Leptomeningeal disease.