M.D. Anderson Cancer Center
To learn if giving 177Lu girentuximab in combination with cabozantinib plus nivolumab can help to control advanced clear cell renal cell carcinoma (ccRCC).
Primary Objectives: * To determine safety of combination 177Lu girentuximab in combination with nivolumab plus cabozantinib in subjects with previously untreated ccRCC. * To evaluate CR rate in the combination of 177Lu girentuximab with nivolumab plus cabozantinib in subjects with previously untreated ccRCC. 2. CR rate by RECIST 1.1 by investigator Secondary Objectives: * To evaluate ORR of 177Lu girentuximab in combination with nivolumab plus cabozantinib in subjects with previously untreated ccRCC. * To evaluate PFS of 177Lu girentuximab in combination with nivolumab plus cabozantinib in…
Inclusion Criteria: 1. Has the ability to understand and willingness to sign a written ICF before the performance of any study-specific procedures on this protocol and 2022-0515 2. Age ≥ 18 years 3. Has locally advanced or metastatic RCC with predominantly clear cell subtype 4. Has at least one measurable lesion as defined by RECIST version 1.1 5. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 6. Has adequate organ function defined as follows: a. Absolute neutrophil count ≥ 1,500/µL, Hgb level ≥ 9 g/dL and platelet count (Plt) i. ≥ 100,000/µL without trans…
Given by IV (vein)
Given by IV (vein)
Given by PO
Given by IV (vein)
Arctuva estimate
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