A Phase II Study of Nivolumab With Ipilimumab and Cabozantinib in Patients With Untreated Renal Cell Carcinoma Brain Metastases
2 other identifiers
interventional
20
1 country
1
Brief Summary
A Phase II Study of Nivolumab with Ipilimumab and Cabozantinib in Patients with Untreated Renal Cell Carcinoma Brain Metastases
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2022
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2021
CompletedFirst Posted
Study publicly available on registry
September 17, 2021
CompletedStudy Start
First participant enrolled
September 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
April 9, 2026
April 1, 2026
5.3 years
September 2, 2021
April 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Nivolumab
EXPERIMENTALby vein every 3 weeks for 4 doses
Ipilimumab
EXPERIMENTALby vein over 30 minutes every 3 weeks for 4 doses
Cabozantinib
EXPERIMENTALtablets by mouth 1 time every day.
Interventions
Eligibility Criteria
You may qualify if:
- Signed Informed Consent Form (ICF)
- Ability and willingness to comply with the requirements of the study protocol
- Age ≥18 years
- Life expectancy \>12 weeks
- 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
- Prior therapies for extracranial metastatic renal cell carcinoma as long as it did not include anti- CTLA-4 or cabozantinib or MET inhibitors
- 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 clinically not indicated or patient is not a suitable candidate to receive immediate local therapy.
- mm to 30mm, as determined by MRI with contrast.
- 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
- +11 more criteria
You may not qualify if:
- Symptomatic brain metastases requiring immediate local interventions such as craniotomy or SRS or whole brain radiation.
- Patients who require immediate surgical or radiotherapy interventions for extra-cranial lesions.
- Radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
- Requiring corticosteroid dose in 10 days prior to administration of first dose of study drug with following exceptions
- \- Symptomatic patients who have stable or decreasing corticosteroid use in the past 10 days may be included
- Patients with Leptomeningeal disease.
- Any approved anticancer therapy, including chemotherapy and hormonal therapy within 4 weeks prior to initiation of study treatment; however, the following are allowed:
- 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)
- Current, recent (within 3 weeks of the first infusion of this study), or planned participation in an experimental drug study.
- AEs from prior anticancer therapy that have not resolved to Grade ≤1 except for alopecia.
- Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; \>Childes A cirrhosis; fatty liver; and inherited liver disease.
- Patients with acute leukemias, accelerated/blast-phase chronic myelogenous leukemia, chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory myeloma.
- Patients who are pregnant, lactating, or breastfeeding.
- Known hypersensitivity to recombinant human antibodies.
- +26 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Exelixiscollaborator
- Bristol-Myers Squibbcollaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianbo Wang
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2021
First Posted
September 17, 2021
Study Start
September 20, 2022
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
April 9, 2026
Record last verified: 2026-04