Phase 1b/2 Study of Combination 177Lu Girentuximab Plus Cabozantinib and Nivolumab in Trea
To learn if giving 177Lu girentuximab in combination with cabozantinib plus nivolumab can help to control advanced clear cell renal cell carcinoma (ccRCC).
| Condition(s) | Advanced Cancer, Clear Cell Renal Cell Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | To learn if giving 177Lu girentuximab in combination with cabozantinib plus nivolumab can help to control advanced clear cell renal cell carcinoma (ccRCC). |
| Who can participate | 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 transfusion or growth factor support within 2 weeks prior to obtaining the hematology values at screening; b. Creatinine clearance ≥ 40 mL/min/1.73m2 c. Transaminase levels (AST/ALT) ≤ 3.0 × upper limit of norm |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | M.D. Anderson Cancer Center |
| Locations | Houston, Texas, United States |
| Start date | 2023-06-30 |
| NCT ID | NCT05663710 |
| Official listing | https://clinicaltrials.gov/study/NCT05663710 |