Trials / Active Not Recruiting
Active Not RecruitingNCT06132945
A Study of Cabozantinib and Nivolumab With Radiation Therapy for People With Renal Cell Carcinoma That Has Spread to the Brain
Phase 1b Study of the Safety of Concurrent Cabozantinib and Nivolumab With Radiation Therapy for Brain Metastases in Patients With Metastatic Renal Cell Carcinoma
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to find out whether the combination of cabozantinib, nivolumab, and radiation therapy is a safe and effective treatment that causes few or mild side effects in people with renal cell cancer that has spread to the brain. The researches will also look at how the study treatment affects the quality of life of participants. They will measure the quality of life by having participants complete questionnaires.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cabozantinib | Cabozantinib (40 mg PO daily) |
| DEVICE | Nivolumab | Nivolumab (480 mg IV Day 1) |
| RADIATION | Stereotactic Radiosurgery (SRS) | Radiation will be stereotactic radiosurgery, delivered over 1-5 fractions with a total dose of 18-30Gy depending on fractionation schedule per the discretion of the treating radiation oncologist. |
Timeline
- Start date
- 2023-11-10
- Primary completion
- 2027-11-01
- Completion
- 2027-11-01
- First posted
- 2023-11-15
- Last updated
- 2025-11-14
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06132945. Inclusion in this directory is not an endorsement.