Who is eligible for clinical trial NCT06699602?

Participants must meet the protocol's inclusion criteria for Renal Cell Carcinoma. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06699602 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-03-02

A Study of Cemiplimab and Fianlimab in People With Clear Cell Renal Cell Carcinoma (NCT06699602)

A Pilot Phase II Study of Neoadjuvant Cemiplimab + Fianlimab in Patients With Locally Advanced Clear Cell Renal Cell Carcinoma Undergoing Nephrectomy

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Memorial Sloan Kettering Cancer Center

🩺 Plain-English Summary (8th-Grade Level)

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 join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (32 items).

Location: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activites) — Basking Ridge, New Jersey

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Age ≥ 18 years at the time of informed consent.
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.
Signed and dated IRB-approved Informed Consent Form
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 an established pre-operative nomogram
Patients must undergo baseline biopsy to confirm clear cell histology prior to treatment initiation.
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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: i. ANC ≥ 1500 cells/μL (without granulocyte colony stimulating factor support within 2 weeks prior to Cycle 1, Day 1) ii. WBC counts ≥ 2500/μL and ≤ 15,000/μL without G-CSF iii. Absolute Lymphocyte count ≥ 500/μL iv. Platelet count ≥100,000/μL (without transfusion within 2 weeks prior to Cycle 1, Day 1) v. Hemoglobin ≥9.0 g/dL (without transfusion within 2 weeks prior to Cycle 1, Day 1) vi. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3 X upper limit of normal (ULN). ALP ≤ 5 x ULN if patient has documented bone metastases. vii. Serum bilirubin ≤ 1.5 x ULN. Patients with known Gilbert disease who have serum bilirubin level ≤ 2 x ULN may be enrolled. viii. Creatinine ≤ 2.0 x ULN or Estimated Glomerular Filtration Rate (eGFR) ≥ 40mL/min using the CKD-EPI formula.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Prior receipt of any systemic therapy for renal cell carcinoma.
Prior receipt of any immune checkpoint inhibitor therapy for any indication.
Inability to safely delay surgery by 9 weeks as per surgeon's discretion.
Patients who are receiving any other investigational agents.
History of allergic reactions or known hypersensitivity attributed to the active substances or to any of the excipients
History of severe hypersensitivity reaction to any monoclonal antibody.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring therapy, symptomatic congestive heart failure, unstable angina pectoris, or uncontrolled cardiac arrhythmia.
Patients with a history of myocarditis.
Patients with Troponin TnT or troponin I TnI \> 2x institutional ULN at baseline. ° Patients with TnT or TnI levels between \> 1 to 2x ULN are permitted if repeat levels within 24 hours are ≤ 1x ULN. If TnT or TnI levels are \> 1 to 2x ULN within 24 hours, the subject may undergo a cardiac evaluation and be considered for treatment by the investigator based on the medical judgement in the patient's best interest.
Patients with active autoimmune disease or recent history (within 2 years) of autoimmune disease that might recur, which may affect vital organ function, or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as SLE, connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event).
Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (7 Sites)

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
Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York

📞 Contact the Study Coordinator

Phone: (646) 888-4721

Email: vossm@mskcc.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Renal Cell Carcinoma

Drug Screening Using Novel IMD in Renal Cell Carcinoma — Boston, Massachusetts
Study of Olaparib in Metastatic Renal Cell Carcinoma Patients With DNA Repair Gene Mutations — Baltimore, Maryland
Molecular Residual Disease (MRD) Guided Adjuvant ThErapy in Renal Cell Carcinoma (RCC) — Birmingham, Alabama
Delving Into Participation Trends in Renal Cell Carcinoma Studies — San Francisco, California
A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Participants With Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma — Birmingham, Alabama

Explore by condition: All Renal Cell Carcinoma clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗