Actively Recruiting
Immunotherapy (Nivolumab and Ipilimumab) With and Without a Live Biotherapeutic Product (EXL01) for the Treatment of Metastatic Renal Cell Cancer
Led by City of Hope Medical Center · Updated on 2026-05-11
33
Participants Needed
2
Research Sites
126 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I trial tests the safety and effectiveness of nivolumab and ipilimumab with and without EXL01 for the treatment of renal cell cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. EXL01 is a live biotherapeutic product containing a strain of bacteria called Faecalibacterium prausnitzii. It may enhance a patient's response to treatment with immune checkpoint inhibitors like nivolumab and ipilimumab by altering the composition of the bacteria in the gut. Adding EXL01 to treatment with nivolumab and ipilimumab may be safe and more effective than giving nivolumab and ipilimumab alone.
CONDITIONS
Official Title
Immunotherapy (Nivolumab and Ipilimumab) With and Without a Live Biotherapeutic Product (EXL01) for the Treatment of Metastatic Renal Cell Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and assent when appropriate
- Agree to allow use of archival tumor tissue or provide new biopsy with PI approval
- Age 18 years or older
- ECOG performance status 0 to 2
- Life expectancy greater than 3 months
- Histologically confirmed renal cell carcinoma with clear cell component
- Advanced or metastatic renal cell carcinoma (AJCC stage IV) with any IMDC risk
- No prior systemic therapy for RCC except one prior adjuvant/neoadjuvant therapy if recurrence after 6 months
- Measurable disease by RECIST 1.1
- Absolute neutrophil count ≥ 1,000/mm³
- Platelets ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- Total bilirubin ≤ 1.5 x ULN (or ≤ 3.0 mg/dL for Gilbert Syndrome)
- AST ≤ 3.0 x ULN
- ALT ≤ upper limit of normal
- Creatinine clearance ≥ 30 mL/min or serum creatinine < 1.5 x ULN
- Appropriate coagulation parameters depending on anticoagulant use
- Undetectable viral load if HIV, hepatitis B or C positive
- Meet institutional infectious disease testing requirements
- Negative pregnancy test for women of childbearing potential within 72 hours of study start
- Agree to use effective contraception during and post treatment for specified durations
- Female subjects of childbearing potential must not be pregnant and meet menopause or sterilization criteria
You will not qualify if you...
- Prior treatment with immune checkpoint inhibitors or drugs targeting T-cell pathways
- Use or intent to use probiotics, prebiotics, or bacterial supplements within 2 weeks before treatment and during treatment
- Use of botanical or herbal supplements for the disease under study
- Fecal microbiota transplant within 3 months prior to screening
- Require chronic antibiotic therapy at enrollment
- Unstable cardiac disease or recent cardiac events
- Active or treated interstitial lung disease requiring steroids
- Medical conditions increasing risk or interfering with safety evaluation
- Systemic anticancer therapy within 4 weeks before study treatment
- Recent radiation therapy within specified time frames
- Known untreated or unstable brain metastases
- Live attenuated vaccine within 30 days before treatment
- Use of systemic corticosteroids or immunosuppressants within 14 days before treatment
- History of significant lung disease or active pneumonitis
- Active inflammatory or serious chronic intestinal diseases with uncontrolled diarrhea
- Active tuberculosis infection
- Major surgery within 28 days prior to treatment
- Malabsorption syndrome or swallowing difficulties
- Recent gastrointestinal parasitic infection
- Allergy or hypersensitivity to study treatments or components
- Hypersensitivity to soy products
- Other active malignancies requiring treatment except certain cured cancers
- Pregnant or breastfeeding women
- Other conditions or disorders precluding safe participation or compliance issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope Medical Center
Irvine, California, United States, 92618
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here