Phase 2 Study of Nivolumab, Ipilimumab, and Cabozantinib for Kidney Cancer Brain Metastases
This Phase 2 study is testing a combination of three medications – nivolumab, ipilimumab, and cabozantinib – for patients with kidney cancer (renal cell carcinoma) that has spread to the brain (brain metastases) and hasn't been treated yet. Researchers want to see if this combination can improve how long patients live without their brain tumors growing (intracranial progression-free survival). You might be able to join if you are 18 or older, have kidney cancer with untreated brain metastases, and meet other health requirements. The study aims to enroll 20 patients. The current recruitment status is unclear.
- Study design
- This is a Phase 2 interventional study, meaning all participants will receive the study medications. It plans to enroll 20 patients.
- What's involved
- Participants will receive nivolumab and ipilimumab intravenously (IV) every 3 weeks for 4 doses, along with daily cabozantinib. After that, nivolumab will be given IV every 4 weeks with daily cabozantinib until the disease progresses or side effects become too severe.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome, intracranial progression-free survival, will be measured through study completion, an average of 1 year.
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NCT05048212
A Phase II Study of Nivolumab With Ipilimumab and Cabozantinib in Patients With Untreated Renal Cell Carcinoma Brain Metastases
Recruiting
PHASE2Ages 18+InterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~20 participants
Updated 2026-04-09 on ClinicalTrials.gov
What's tested:NivolumabIpilimumabCabozantinib
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To associate if the combination of nivolumab with ipilimumab and cabozantinib produces improvesintracranial progression-free survival (PFS) in patients.
Measured over through study completion, an average of 1 year
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Jianbo Wang · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Immediate local therapy clinically not indicated or patient is not a suitable candidate to receive immediate local therapy.
5mm to 30mm, as determined by MRI with contrast. 8. Adequate hematologic and essential organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment (C1D1)
Absolute neutrophil count (ANC) ≥1500 cells/µL
White blood cell (WBC) counts \>2500/µ -- Lymphocyte count ≥500/µL
Platelet count ≥ 100,000/µL;
Hemoglobin ≥9.0 g/dL
Serum albumin≥2.8g/dl
Total bilirubin ≤1.5×upper limit of normal (ULN) with the following exception:
Aspartate aminotransferase (AST) ≤ 3x upper limit of normal (ULN).
Alkaline phosphatase ≤5×ULN in patients with documented bone metastases.
Serum creatinine ≤ 1.5x ULN or calculated creatinine clearance ≥ 40mL/min (≥ 0.675mL/sec) using the Cockcroft-Gault equation: Males: (140 - age) x weight (kg)/(serum creatinine \[mg/dL\] × 72)Females: \[(140 - age) x weight (kg)/(serum creatinine \[mg/dL\] × 72)\] × 0.85
Urine protein/creatinine ratio (UPCR) ≤ 1 mg/mg (≤ 113.2 mg/mmol), or 24-h urine protein ≤ 1 g. 9. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use highly effective form(s) of contraception (i.e., one that results in a low failure rate \[\<1% per year\] when used consistently and correctly) and to continue its use for at least 12 months after the last dose of Cabozantinib and Nivolumab 10. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 (see Appendix 5) 11. INR and aPTT ≤1.5×ULN within 7 days prior to study enrollment 12. Recovery to baseline or ≤ Grade 1 CTCAE v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
Exclusion
Hormone-replacement therapy or oral contraceptives
Herbal therapy \>1 week prior to Cycle 1, Day 1 (herbal therapy intended as anticancer therapy must be discontinued at least 1 week prior to Cycle 1,Day 1) 7. Current, recent (within 3 weeks of the first infusion of this study), or planned participation in an experimental drug study. 8. AEs from prior anticancer therapy that have not resolved to Grade ≤1 except for alopecia. 9. Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; \>Childes A cirrhosis; fatty liver; and inherited liver disease. 10. Patients with acute leukemias, accelerated/blast-phase chronic myelogenous leukemia, chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory myeloma. 11. Patients who are pregnant, lactating, or breastfeeding. 12. Known hypersensitivity to recombinant human antibodies. 13. Inability to undergo MRI secondary to Metal implant and Gadolinium contrast allergy. 14. Inability to comply with study and follow-up procedures. 15. History of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome,
Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.
Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible
Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:
Rash must cover less than 10% of body surface area (BSA), Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%).
No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation \[PUVA\], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids) 16. History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan with the following exception
History of radiation pneumonitis in the radiation field (fibrosis) is permitted. 17. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications. 18. History of HIV infection or active hepatitis B (chronic or acute) or hepatitis C infection with the following exception:
Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen \[HBsAg\] test and a positive anti-HBc \[antibody to hepatitis B core antigen\] antibody test) are eligible.
Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA. 19. Active tuberculosis. 20. Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia 21. Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1. 22. Received oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1 with the following exception.
What this trial measures
- To associate if the combination of nivolumab with ipilimumab and cabozantinib produces improvesintracranial progression-free survival (PFS) in patients.through study completion, an average of 1 year