NCT07128680View on ClinicalTrials.gov

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

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

December 5, 2025

Primary Completion Date

June 2, 2027

Study Completion Date

June 2, 2027

Conditions
Advanced Clear Cell Renal Cell CarcinomaAdvanced Sarcomatoid Renal Cell CarcinomaMetastatic Clear Cell Renal Cell CarcinomaMetastatic Sarcomatoid Renal Cell CarcinomaStage III Renal Cell Cancer AJCC v8Stage IV Renal Cell Cancer AJCC v8
Interventions
PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

PROCEDURE

Bone Scan

Undergo bone scan

PROCEDURE

Computed Tomography

Undergo CT

DIETARY_SUPPLEMENT

Faecalibacterium prausnitzii-containing Bacterial Strain Formulation EXL01

Given PO

BIOLOGICAL

Ipilimumab

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Nivolumab

Given IV

Trial Locations (2)

91010

City of Hope Medical Center, Duarte

92618

City of Hope Medical Center, Irvine

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

City of Hope Medical Center

OTHER