Actively Recruiting
A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or 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
239 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 three-arm randomized phase 2 trial will enroll advanced clear cell RCC patients (all IMDC risk groups). Patients will be randomized 2:2:1 to either Arm A (fianlimab/ cemiplimab/ ipilimumab), Arm B (fianlimab/ cemiplimab), or Arm C (standard ipilimumab/ nivolumab), respectively.
CONDITIONS
Official 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 joining the study
- Age 18 years or older at time of consent
- Karnofsky Performance Status of 70% or higher within 14 days before registration
- Histological or cytological confirmation of renal cell carcinoma with a clear cell component
- Advanced or metastatic renal cell carcinoma not suitable for curative surgery or radiation
- No previous systemic treatment for renal cell carcinoma, including neo/adjuvant therapy
- Measurable disease according to RECIST 1.1 within 28 days before registration
- Availability of a tumor tissue sample from a metastatic lesion or primary kidney cancer within 3 to 12 months
- Adequate organ function based on screening lab tests within 14 days before registration
- Negative pregnancy test for females of childbearing potential within 14 days before registration
- Use of effective contraception or abstinence for sexually active females and males able to father a child
- HIV-positive patients on stable anti-retroviral therapy with undetectable viral load and CD4 count above 350
- Patients with chronic hepatitis B on suppressive therapy and undetectable viral load
- Patients cured of hepatitis C with undetectable viral load or currently on treatment with undetectable viral load
- Ability to understand and comply with study procedures throughout the study period
You will not qualify if you...
- Prior systemic therapy for renal cell carcinoma in any setting
- Use of prednisone equivalent to 10 mg or higher daily
- History of myocarditis
- Presence of autoimmune diseases requiring systemic immunosuppressive treatment within past 2 years except select conditions
- Central nervous system metastases
- Active infection requiring systemic therapy
- Pregnancy or breastfeeding
- Other cancers that might interfere with study safety or results
- Use of live vaccines within 4 weeks before or during the study
- Known allergy to study drugs or their ingredients
- Participation in another clinical trial or investigational treatment within 30 days prior to study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
B
Brian Rini, MD
CONTACT
A
Allison Lipps
CONTACT
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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