A Pilot Phase II Study of Neoadjuvant Cemiplimab + Fianlimab in Patients With Locally Advanced Clear Cell Renal Cell Carcinoma Undergoing Nephrectomy
Memorial Sloan Kettering Cancer Center
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 t…
Interventions
- DrugCemiplimab
cemiplimab IV flat
- DrugFianlimab
fianilmab IV flat
Locations (7)
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activites)Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering Cancer Center Suffolk - Commack (Limited Protocol Activities)Commack, New York
- Memorial Sloan Kettering West Harrison (Limited Protocol Activities)Harrison, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activites)New York, New York