Actively Recruiting
A Study of Cemiplimab and Fianlimab in People With Clear Cell Renal Cell Carcinoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-04
10
Participants Needed
7
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Cemiplimab and Fianlimab in People With Clear Cell Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of consent
- Ability to provide informed consent or have a legal representative provide consent
- Signed and dated IRB-approved informed consent form
- Planned nephrectomy for high-risk non-metastatic clear cell renal cell carcinoma
- Non-metastatic defined as no metastases except regional lymphadenopathy confirmed by imaging
- High-risk defined by a 12-year metastasis probability of 30% or greater by pre-operative nomogram
- Baseline biopsy confirming clear cell histology before treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and bone marrow function as shown by specified lab results within 14 days before treatment
You will not qualify if you...
- Prior systemic therapy for renal cell carcinoma
- Prior immune checkpoint inhibitor therapy for any reason
- Inability to safely delay surgery by 9 weeks as assessed by surgeon
- Receiving any other investigational agents
- History of allergic reactions or hypersensitivity to study drugs or excipients
- History of severe hypersensitivity to any monoclonal antibody
- Uncontrolled illnesses including active infection, symptomatic heart failure, unstable angina, or uncontrolled arrhythmia
- History of myocarditis
- Elevated troponin levels above specified limits
- Active or recent autoimmune disease affecting vital organs or requiring immune suppression
- Use of systemic corticosteroids or immunosuppressive drugs within 14 days before treatment
- Diagnosis of another malignancy within 2 years except certain cured localized tumors
- Prior allogeneic stem cell or solid organ transplant
- Recent significant infection requiring antibiotics within 2 weeks before treatment
- Use of live vaccines within 30 days before treatment
- Uncontrolled HIV, hepatitis B or C infection unless controlled and monitored
- Positive pregnancy test or breastfeeding
- Women of childbearing potential not willing to use effective contraception during and after study
- Men with partners of childbearing potential not using condoms or abstinence during and after study
- Agreement by participants not to donate eggs or sperm during and after study
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activites)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering West Harrison (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
M
Martin Voss, MD
CONTACT
A
Abraham Hakimi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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