Immunotherapy (Nivolumab and Ipilimumab) With and Without a Live Biotherapeutic Product (EXL01) for the Treatment of Metastatic Renal Cell Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT07128680
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Clear Cell Renal Cell Carcinoma
  • Advanced Sarcomatoid Renal Cell Carcinoma
  • Metastatic Clear Cell Renal Cell Carcinoma
  • Metastatic Sarcomatoid Renal Cell Carcinoma
  • Stage III Renal Cell Cancer AJCC v8
  • Stage IV Renal Cell Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Bone Scan — PROCEDURE
    Undergo bone scan
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Faecalibacterium prausnitzii-containing Bacterial Strain Formulation EXL01 — DIETARY_SUPPLEMENT
    Given PO
  • Ipilimumab — BIOLOGICAL
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Mar 23, 2026
Status verified
May 2026
Primary completion
Aug 25, 2028
Completion
Aug 25, 2028

Study Design

Enrollment
33 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (nivolumab, ipilimumab, EXL01)
    CYCLES 1-4: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1 of each cycle and receive EXL01 PO QD on days 1-21 of each cycle. Cycles repeat every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. CYCLES 5+: Patients continue receiving nivolumab IV over 30 minutes on day 1 of each cycle and EXL01 PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and collection of blood samples throughout the study. Patients may undergo MRI at screening and may undergo bone scan as clinically indicated.
  • Active Comparator: Arm B (nivolumab, ipilimumab)
    CYCLES 1-4: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. CYCLES 5+: Patients continue receiving nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and collection of blood samples throughout the study. Patients may undergo MRI at screening and may undergo bone scan as clinically indicated.

Primary Outcome Measure

Change in plasma IFNγ [ Time Frame: At baseline and week 13 ]

Locations (2)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Sumanta K. Pal
[email protected]
626-256-4673
Sumanta K. Pal (PRINCIPAL_INVESTIGATOR)
City of Hope Medical CenterIrvineCalifornia92618
Sumanta K. Pal
[email protected]
626-256-4673
Sumanta K. Pal (PRINCIPAL_INVESTIGATOR)

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