Actively Recruiting
A Randomized Phase 2 Trial of Nivolumab, Relatlimab Plus Ipilimumab vs. Nivolumab Plus Ipilimumab in First-line Advanced Renal Cell Carcinoma (RCC)
Led by M.D. Anderson Cancer Center · Updated on 2026-05-14
15
Participants Needed
6
Research Sites
195 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase 2 stratified, randomized, multicenter, study investigating the efficacy of a triplet arm treating with nivolumab 480 mg every 4 weeks (Q4W), relatlimab 160 mg Q4W and ipilimumab 1 mg/kg every 8 weeks (Q8W) intravenous (IV) versus a doublet arm treating with nivolumab 480 mg Q3W and ipilimumab 1mg/kg Q3W IV in first-line advanced RCC.
CONDITIONS
Official Title
A Randomized Phase 2 Trial of Nivolumab, Relatlimab Plus Ipilimumab vs. Nivolumab Plus Ipilimumab in First-line Advanced Renal Cell Carcinoma (RCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide signed informed consent
- At least 18 years old
- Confirmed diagnosis of renal cell carcinoma with a clear cell component
- Stage IV metastatic renal cell carcinoma
- No prior systemic therapy for RCC, including neoadjuvant or adjuvant treatments
- Karnofsky performance status of 70% or higher
- At least one measurable lesion per RECIST 1.1 criteria
- Adequate organ function within 28 days before treatment, including specified blood counts and liver/kidney function
- Women must not be breastfeeding during and for up to five months after treatment
- Women of childbearing potential must have a negative pregnancy test before starting treatment
- Women of childbearing potential must agree to use acceptable contraception during and for 23 weeks after treatment
You will not qualify if you...
- Any prior systemic treatment for RCC
- Major surgery requiring general anesthesia within 28 days before treatment
- Radiosurgery, radiotherapy, minor surgery, or active infection needing infusion treatment within 14 days before treatment
- History or presence of central nervous system metastases
- Use of systemic corticosteroids or other immunosuppressive medications exceeding specified doses within 14 days before treatment
- Active, known, or suspected autoimmune disease (except certain controlled conditions)
- Known psychiatric or medical conditions that increase risk or impair consent or compliance
- History of myocarditis
- Elevated troponin T or I levels above specified institutional limits
- Treatment with any live or attenuated vaccine within 30 days before first study treatment
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
3
Penn Medicine Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
4
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
5
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
6
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Eric Jonasch, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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