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

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

Trial Details

NCT ID

NCT07128680

Phase

PHASE1

Sponsor

City of Hope Medical Center

Status

RECRUITING

Cancer Type

Kidney Cancer

Interventions

Biospecimen Collection
Bone Scan
Computed Tomography
Faecalibacterium prausnitzii-containing Bacterial Strain Formulation EXL01
Ipilimumab
Magnetic Resonance Imaging

Locations (sample)

Duarte, California, United States|34.13945,-117.97729
Irvine, California, United States|33.66946,-117.82311

Key Eligibility Criteria

Documented informed consent of the participant and/or legally authorized representative
Assent, when appropriate, will be obtained per institutional guidelines
Agreement to allow the use of archival tissue from diagnostic tumor biopsies
If unavailable, exceptions may be granted with study principal investigator (PI) approval

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Kidney Cancer Trials on Trialify →