Actively Recruiting
A Phase II Study of Nivolumab With Ipilimumab and Cabozantinib in Patients With Untreated Renal Cell Carcinoma Brain Metastases
Led by M.D. Anderson Cancer Center · Updated on 2026-04-09
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
E
Exelixis
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial investigates a phase II study of combining three drugs—nivolumab, ipilimumab, and cabozantinib—in patients who have untreated brain metastases from renal cell carcinoma (RCC). The purpose is to evaluate the safety and effectiveness of this combination treatment until the disease worsens, side effects become intolerable, or the patient chooses to stop. The study plans to enroll 40 patients and includes a safety lead-in group of 6 patients to closely monitor early side effects. Participants initially receive nivolumab and ipilimumab intravenously every three weeks for four doses, along with daily oral cabozantinib. After this initial phase, nivolumab is given intravenously every four weeks with continued daily cabozantinib until disease progression or intolerable side effects occur. If more than three patients in the lead-in group experience serious side effects, the treatment will be adjusted to exclude ipilimumab. During the study, patients will undergo assessments including MRI scans to measure brain tumors, blood tests to check organ function, and monitoring for side effects. The main outcome measured is intracranial progression-free survival over about one year. Participants will be regularly evaluated throughout treatment with ongoing safety monitoring until the study ends.
CONDITIONS
Brief Title
A Phase II Study of Nivolumab With Ipilimumab and Cabozantinib in Patients With Untreated Renal Cell Carcinoma Brain Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Willingness and ability to follow the study protocol
- Age 18 years or older
- Life expectancy greater than 12 weeks
- Asymptomatic and off steroids for at least 10 days, except mild intracranial symptoms not affecting performance
- Prior treatments allowed except anti-CTLA-4, cabozantinib, or MET inhibitors
- Histologically confirmed metastatic renal cell carcinoma with at least one measurable brain lesion (5mm to 30mm) untreated or progressing after local therapy
- Adequate blood counts and organ function within 14 days before first treatment
- Agreement to use effective contraception for 12 months after last dose if applicable
- ECOG performance status 0 to 2
- Normal INR and aPTT within 7 days before enrollment
- Recovery to baseline or grade 1 or less from prior treatment toxicities unless clinically nonsignificant and stable
You will not qualify if you...
- Symptomatic brain metastases needing immediate local treatment
- Need for urgent surgery or radiation for extracranial lesions
- Recent radiation therapy within 2-4 weeks or ongoing complications from radiation
- Corticosteroid use within 10 days before first dose except stable or decreasing use
- Leptomeningeal disease
- Recent anticancer therapy within 4 weeks except certain hormonal or herbal therapies
- Participation in experimental drug study within 3 weeks or planned
- Unresolved adverse events from prior therapy except alopecia
- Significant liver disease
- Certain blood cancers
- Pregnancy or breastfeeding
- Hypersensitivity to human antibodies
- Inability to undergo MRI due to metal implants or contrast allergy
- Inability to comply with study procedures
- History of autoimmune diseases except controlled thyroid disease, type 1 diabetes, or certain skin conditions
- History of certain lung diseases or active pneumonitis except radiation fibrosis
- Other medical conditions that increase risk or affect results
- HIV infection or active hepatitis except resolved cases
- Active tuberculosis
- Recent severe infections or antibiotic use except prophylactic
- Live vaccine within 4 weeks before treatment
- Other malignancies within 5 years except low-risk or treated cancers
- Life expectancy less than 12 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Until disease progression, intolerable toxicities, or patient withdrawal
Participants receive nivolumab and ipilimumab by IV every 3 weeks for 4 doses, alongside daily oral cabozantinib. After initial doses, participants continue nivolumab IV every 4 weeks with daily cabozantinib until disease progression, intolerable toxicities, or withdrawal.
IV infusions every 3 weeks for 4 doses, then every 4 weeks; daily oral medication
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jianbo Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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