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

NCT06699602 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 24-329
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Renal Cell Carcinoma

Keywords

Cemiplimab; Fianlimab

Outcome Measures

Primary Outcomes (1)

• response

  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

  1 year

Study Arms (1)

Cemiplimab and Fianlimab

EXPERIMENTAL

All patients will be treated as follows: cemiplimab and fianlimab every 3 weeks for a total of 3 treatments, or until unacceptable toxic effects, overt disease progression, or withdrawal from study.

Drug: Cemiplimab; Drug: Fianlimab

Interventions

Cemiplimab DRUG

cemiplimab IV flat

Cemiplimab and Fianlimab

Fianlimab DRUG

fianilmab IV flat

Cemiplimab and Fianlimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy.
• Prior allogeneic stem cell transplant or solid organ transplant.
• History or current evidence of significant (CTCAE grade ≥2) local or systemic infection (eg, cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activites)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Cancer Center Suffolk - Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering West Harrison (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Martin Voss, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Voss, MD

CONTACT

646-888-4721; vossm@mskcc.org

Abraham Hakimi, MD

CONTACT

646-422-4497; hakimia@mskcc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start: February 11, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (7)