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
275 weeks
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
A Phase II Study of Nivolumab with Ipilimumab and Cabozantinib in Patients with Untreated Renal Cell Carcinoma Brain Metastases
CONDITIONS
Official 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 study requirements
- Age 18 years or older
- Life expectancy greater than 12 weeks
- Asymptomatic brain metastases or mild symptoms not affecting performance status, off steroids for at least 10 days
- Prior therapies allowed if they did not include anti-CTLA-4 or cabozantinib or MET inhibitors
- Histologically confirmed metastatic renal cell carcinoma with at least one measurable brain metastasis (5mm to 30mm) untreated or progressive after local therapy
- Adequate blood counts and organ function based on lab tests within 14 days before treatment
- Agreement by patients of childbearing potential and their partners to use highly effective contraception during and for 12 months after treatment
- ECOG performance status of 0 to 2
- INR and aPTT less than or equal to 1.5 times upper limit of normal within 7 days prior to enrollment
- Recovery to baseline or Grade 1 or less from prior treatment toxicities unless clinically nonsignificant or stable on supportive therapy
You will not qualify if you...
- Symptomatic brain metastases requiring immediate surgery or radiation
- Immediate need for surgery or radiation for extracranial lesions
- Recent radiation therapy within 2 to 4 weeks before study treatment or ongoing complications from prior radiation
- Use of corticosteroids within 10 days before starting study drug except stable or decreasing doses in symptomatic patients
- Presence of leptomeningeal disease
- Use of other anticancer therapies within 4 weeks before study treatment except hormone replacement or oral contraceptives
- Participation in other experimental drug studies recently or planned
- Unresolved adverse events from prior cancer treatments except alopecia
- Significant liver disease or certain blood cancers
- Pregnant or breastfeeding women
- Known allergies to recombinant human antibodies
- Inability to have MRI due to metal implants or contrast allergy
- Inability to comply with study procedures
- History of severe autoimmune diseases except controlled hypothyroidism, type 1 diabetes, or mild skin conditions under specific conditions
- History or evidence of certain lung diseases or active pneumonitis
- Other diseases or conditions that increase risk or affect study results
- History of HIV or active hepatitis B or C except resolved infections
- Active tuberculosis
- Recent severe infections or signs of infection within 2 weeks before treatment
- Recent use of antibiotics except for prophylactic use
- Recent live attenuated vaccine within 4 weeks before treatment or planned
- Other malignancies within 5 years except certain low-risk or treated cancers
- Life expectancy less than 12 weeks
AI-Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Jianbo Wang
CONTACT
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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