A Study of Cemiplimab and Fianlimab for Kidney Cancer
This study is looking at whether giving two immunotherapy drugs, cemiplimab and fianlimab, before surgery (nephrectomy) for kidney cancer is practical and safe. Researchers want to see if this treatment delays surgery and if it helps shrink tumors. The study will also check how well people respond to the treatment after one year. You may be able to join if you are at least 18 years old and have kidney cancer. The study plans to enroll 10 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 10 people.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, response, is measured at 1 year.
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NCT06699602
A Study of Cemiplimab and Fianlimab in People With Clear Cell Renal Cell Carcinoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~10 participants
Updated 2026-03-04 on ClinicalTrials.gov
What's tested:CemiplimabFianlimab
At a glance
Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
response
Measured over 1 year
Conditions
Where it's being run
7 sites across 2 statesNew York4
New Jersey3
Study leadership
- Martin Voss, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 an established pre-operative nomogram 5. Patients must undergo baseline biopsy to confirm clear cell histology prior to treatment initiation. 6. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 7. Patients must have adequate organ and bone marrow function, defined by the following laboratory results obtained within 14 days prior to the first study treatment:
Exclusion
Patients with known HIV infection who have controlled infection (undetectable viral load on HIV RNA PCR) and CD4 count above 350 (either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards.
Patients with HBV (hepatitis B surface antigen positive; HBsAg+) who have controlled infection (serum HBV DNA PCR that is below the limit of detection and receiving anti-viral therapy for HBV) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA. Patients must remain on anti-viral therapy for at least 6 months after the last dose of cemiplimab.
Patients who are HCV antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR, either spontaneously or in response to successful prior course of anti-HCV therapy) are permitted.
Patients with HIV or hepatitis must be reviewed by a qualified specialist (eg, infectious disease or hepatologist) managing this disease prior to commencing and regularly throughout the duration of their participation in the trial 17. Women with a positive serum beta-hCG pregnancy test at screening/baseline visit. If positive, pregnancy must be ruled out by ultrasound for patient to be eligible. 18. Breast-feeding women. 19. Women of childbearing potential (WOCBP) who are sexually active and are not willing to practice highly effective contraception prior to the first treatment, during the study, and for at least 6 months after the last dose. Highly effective contraceptive measures include:
stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening;
intrauterine device; intrauterine hormone-releasing system;
bilateral tubal occlusion/ligation;
vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure); and/or
sexual abstinence - Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drugs. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject. 20. Male study participants with WOCBP partners are required to use condoms during the study and until 6 months after the last dose of study treatment unless they are vasectomized or practice sexual abstinence. 21. WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial and until 6 months after last treatment. 22. All men must agree not to donate sperm during the trial and for 6 months after receiving the last therapy dose.
What this trial measures
- response1 year
will be evaluated in this study using the international criteria proposed by RECIST version 1.1. Changes in the largest diameter (unidimensional measurement) of the tumor lesion and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria