A Phase II Study of Nivolumab With Ipilimumab and Cabozantinib in Patients With Untreated
A Phase II Study of Nivolumab with Ipilimumab and Cabozantinib in Patients with Untreated Renal Cell Carcinoma Brain Metastases
| Condition(s) | Brain Metastases, Renal Cell Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | A Phase II Study of Nivolumab with Ipilimumab and Cabozantinib in Patients with Untreated Renal Cell Carcinoma Brain Metastases |
| Who can participate | Inclusion Criteria 1. Signed Informed Consent Form (ICF) 2. Ability and willingness to comply with the requirements of the study protocol 3. Age ≥18 years 4. Life expectancy \>12 weeks 5. 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 6. Prior therapies for extracranial metastatic renal cell carcinoma as long as it did not include anti- CTLA-4 or cabozantinib or MET inhibitors 7. Patients with histologically confirmed metastatic renal cell carcinoma and at least one measurable intracranial target lesion for which all of the following criteria are met: \- Previously untreated or progressive after previous local therapy(limited to SRS and surgery) * Immediate local therapy clinic |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | M.D. Anderson Cancer Center |
| Locations | Houston, Texas, United States |
| Start date | 2022-09-20 |
| NCT ID | NCT05048212 |
| Official listing | https://clinicaltrials.gov/study/NCT05048212 |