A Study of Cemiplimab and Fianlimab in People With Clear Cell Renal Cell Carcinoma
The researchers are doing this study to find out whether it is practical (feasible) to give cemiplimab and fianlimab before a nephrectomy and whether it causes any delays with surgery in people with kidney cancer. The researchers will also look at whether cemiplimab and fianlimab given before a nephrectomy is a safe an
| Condition(s) | Renal Cell Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The researchers are doing this study to find out whether it is practical (feasible) to give cemiplimab and fianlimab before a nephrectomy and whether it causes any delays with surgery in people with kidney cancer. The researchers will also look at whether cemiplimab and fianlimab given before a nephrectomy is a safe and effective treatment approach and if there is a change in the size of the tumor following immunotherapy prior to planned surgery. |
| Who can participate | Inclusion Criteria: 1. Age ≥ 18 years at the time of informed consent. 2. Patient must be able to provide informed consent, or a legal authorized representative (LAR) must be identified to provide consent in cases where the patient cannot. 3. Signed and dated IRB-approved Informed Consent Form 4. Patients must be planned for nephrectomy for high risk non-metastatic clear cell renal cell carcinoma. * Non-metastatic disease will be defined by no evidence of metastases other than regional lymphadenopathy as assessed by imaging of the chest, abdomen and pelvis with CT of the chest and MR of the abdomen/pelvis (CT abdomen/pelvis will suffice for those unable to undergo MR imaging). * 'High-risk non-metastatic' is defined as those patients with a 12-year probability of metastases of ≥ 30% as per |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
| Locations | Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States (+1 more sites) |
| Start date | 2025-02-11 |
| NCT ID | NCT06699602 |
| Official listing | https://clinicaltrials.gov/study/NCT06699602 |