Phase 1b/2 Study of Combination 177Lu Girentuximab Plus Cabozantinib and Nivolumab in Treatment naïve Patients With Advanced Clear Cell RCC
M.D. Anderson Cancer Center
Summary
To learn if giving 177Lu girentuximab in combination with cabozantinib plus nivolumab can help to control advanced clear cell renal cell carcinoma (ccRCC).
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- Drug177Lu girentuximab
Given by IV (vein)
- DrugNivolumab
Given by IV (vein)
- DrugCabozantinib
Given by PO
- DrugArabinoFuranosylGuanine [18F]F-AraG
Given by IV (vein)
Location
- MD Anderson Cancer CenterHouston, Texas