Actively Recruiting
A Randomized Study of Nivolumab and Ipilimumab With and Without EXL01 in First-Line Treatment of Metastatic Renal Cell Carcinoma (mRCC)
Led by City of Hope Medical Center · Updated on 2026-05-11
33
Participants Needed
2
Research Sites
N/A
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
Researchers are evaluating a phase I trial to test the safety and effects of combining immunotherapy drugs nivolumab and ipilimumab with or without a live biotherapeutic product called EXL01 in patients with metastatic renal cell cancer. This cancer has spread from its original site to other parts of the body. The study aims to see if adding EXL01, which contains a specific strain of gut bacteria, can improve the immune system's response to treatment and potentially enhance the effectiveness of the immunotherapy. Participants are randomly assigned to one of two study groups. In the first group, patients receive nivolumab and ipilimumab intravenously every 21 days for four cycles, along with daily oral doses of EXL01 for 21 days each cycle. After four cycles, nivolumab continues every 28 days with EXL01 daily for 28 days per cycle. The second group receives only the two immunotherapy drugs on the same schedule without EXL01. Treatment continues unless the disease worsens or side effects become unacceptable. Throughout the study, participants will have CT scans and blood samples collected regularly, with optional MRI and bone scans as needed. After finishing treatment, patients are followed up within 30 days and then every three months for up to two years. The main outcomes measured include changes in immune system markers, safety and side effects, tumor response, progression-free survival, and overall survival during this period.
CONDITIONS
Brief 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
- Agreement to allow use of archival tumor tissue or investigator approval if unavailable
- 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 of any risk category by IMDC criteria
- No prior systemic therapy for RCC except certain adjuvant/neoadjuvant therapy with conditions
- Measurable disease per RECIST 1.1
- Adequate blood counts: ANC ≥ 1,000/mm³, platelets ≥ 100,000/mm³, hemoglobin ≥ 9 g/dL
- Liver and kidney function within specified limits
- Coagulation tests within acceptable ranges depending on anticoagulant use
- If HIV, HCV, or HBV positive, viral load must be undetectable
- Negative pregnancy test for women of childbearing potential
- Agreement to use contraception during and after treatment periods
- Female subjects 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 of probiotics, prebiotics, bacterial supplements, or botanical preparations within 2 weeks before treatment
- Fecal microbiota transplant within 3 months before screening
- Chronic antibiotic therapy at enrollment
- Unstable cardiac disease or recent major cardiac events
- Active or history of interstitial lung disease requiring steroids
- Serious medical conditions increasing risk or interfering with safety assessment
- Recent cytotoxic or systemic cancer therapy within 4 weeks before treatment
- Recent radiation therapy within specified time frames
- Untreated or unstable brain metastases
- Live vaccines within 30 days before treatment
- Systemic corticosteroids or immunosuppressants within 14 days before treatment
- Active inflammatory or serious intestinal disease
- Active tuberculosis or recent major surgery within 4 weeks
- Malabsorption syndrome or swallowing difficulties
- GI parasitic infection within 3 months before screening
- Allergies to study drug components or severe infusion reactions
- Hypersensitivity to soy products
- Other active malignancies requiring treatment within 3 years except certain cured cancers
- Pregnant or breastfeeding females
- Any other condition or inability to comply that would pose safety concerns or interfere with study procedures
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 approximately 2 years depending on treatment continuation
Participants receive intravenous nivolumab and ipilimumab on day 1 of each 21-day cycle for the first 4 cycles. Participants in Arm A also take the oral bacterial supplement EXL01 daily during these cycles. From cycle 5 onward, participants continue with intravenous nivolumab every 28 days, and those in Arm A continue daily oral EXL01. Treatment continues in the absence of disease progression or unacceptable toxicity. Participants undergo CT scans and blood sample collections throughout the treatment period. MRI may be performed at screening and bone scans as clinically indicated.
1 visit every 21 days for first 4 cycles, then every 28 days thereafter
Duration - Up to 2 years
After completing treatment, participants are followed up within 30 days and then every 3 months for up to 2 years to monitor safety and long-term outcomes.
Visits every 3 months
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
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