Actively Recruiting
A Randomized Phase 2 Trial of Fianlimab and Cemiplimab with or without Ipilimumab versus Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)
Led by Brian Rini · Updated on 2026-05-01
120
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
B
Brian Rini
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial studies patients with advanced clear cell renal cell carcinoma (RCC), including all IMDC risk groups, who have not received prior systemic therapy. It is a randomized phase 2 study comparing three treatment approaches aiming to evaluate their effects on tumor response and progression. The trial is led by Brian Rini and focuses on first-line treatments for advanced RCC. Participants are randomly assigned to one of three groups: Arm A receives a combination of fianlimab, cemiplimab, and ipilimumab administered intravenously; Arm B receives fianlimab and cemiplimab by intravenous infusion; Arm C receives the standard treatment of ipilimumab plus nivolumab, both given intravenously with maintenance nivolumab following the combination phase. Treatments are given according to the study schedule. Throughout the trial, participants will have scans and assessments to measure tumor response using RECIST 1.1 criteria, organ function tests, and other safety labs. The main outcome measured is the objective response rate over two years. Secondary outcomes include progression-free survival, duration of response, treatment-free survival, and adverse event rates monitored for up to five years. Participants will be closely followed with regular visits and laboratory tests during the study period.
CONDITIONS
Brief Title
A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and HIPAA authorization before registration
- Age 18 years or older at consent
- Karnofsky Performance Status of 70% or higher within 14 days prior to registration
- Histological or cytological evidence of renal cell carcinoma with a clear cell component
- Advanced or metastatic (AJCC Stage IV) renal cell carcinoma not suitable for curative surgery or radiation
- No prior systemic therapy for renal cell carcinoma, including no neo/adjuvant systemic treatment
- Measurable disease by RECIST 1.1 within 28 days prior to registration
- Availability of tumor tissue samples preferably from a metastatic lesion within 3 to 12 months
- Adequate organ function as defined in the protocol with labs within 14 days prior to registration
- Negative serum pregnancy test for females of childbearing potential within 14 days prior to registration
- Agreement to use effective contraception or abstain from penile-vaginal intercourse if sexually active and of childbearing potential
- Known HIV-positive subjects on stable antiretroviral therapy with undetectable viral load and adequate CD4 count
- Subjects with controlled hepatitis B or cured hepatitis C infection as defined
- Ability to understand and comply with study procedures for the entire study duration
You will not qualify if you...
- Prior systemic therapy for renal cell carcinoma in any setting
- Ongoing use of 10 mg or more prednisone equivalent per day
- History of myocarditis
- Recent or ongoing autoimmune disease requiring systemic immunosuppressive treatment, except certain allowed conditions
- Presence of central nervous system metastases
- Active infection requiring systemic therapy
- Pregnant or breastfeeding women
- Prior or current malignancies that may interfere with study assessments
- Receipt of live attenuated vaccines within 4 weeks before treatment or during the study
- Known hypersensitivity to study drugs or excipients
- Participation in another investigational study within 30 days before the first dose of study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years or until disease progression or unacceptable toxicity
Participants receive intravenous infusions of study drugs including Fianlimab, Cemiplimab, Ipilimumab, and/or Nivolumab according to their assigned treatment arm.
Regular visits for infusions and assessments as per protocol
Duration - Up to 5 years
Participants are monitored for long-term safety and treatment outcomes after completing or discontinuing treatment.
Periodic visits for safety and efficacy assessments
Trial Site Locations
Total: 1 location
1
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
B
Brian Rini, MD
A
Allison Lipps
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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