A Phase II Study of Nivolumab With Ipilimumab and Cabozantinib in Patients With Untreated Renal Cell Carcinoma Brain Metastases

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05048212
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

A Phase II Study of Nivolumab with Ipilimumab and Cabozantinib in Patients with Untreated Renal Cell Carcinoma Brain Metastases

Key Dates

Start date
Sep 20, 2022
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab
    by vein every 3 weeks for 4 doses
  • Experimental: Ipilimumab
    by vein over 30 minutes every 3 weeks for 4 doses
  • Experimental: Cabozantinib
    tablets by mouth 1 time every day.

Primary Outcome Measure

To associate if the combination of nivolumab with ipilimumab and cabozantinib produces improvesintracranial progression-free survival (PFS) in patients. [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Jianbo Wang, MD
[email protected]
713-792-3393
Jianbo Wang, MD (PRINCIPAL_INVESTIGATOR)

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