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NCT07128680 · ClinicalTrials.gov registry record · Phase 1
Immunotherapy (Nivolumab and Ipilimumab) With and Without a Live Biotherapeutic Product (EXL01) for the Treatment of Metastatic Renal Cell Cancer
A Phase 1 study of Stage IV Renal Cell Cancer AJCC v8 and Stage III Renal Cell Cancer AJCC v8, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
- 2
- Study locations
NCT07128680: Recruiting Phase 1 study of Stage IV Renal Cell Cancer AJCC v8 and Stage III Renal Cell Cancer AJCC v8, sponsored by City of Hope Medical Center.
NCT07128680 is a Phase 1 study of Stage IV Renal Cell Cancer AJCC v8 and Stage III Renal Cell Cancer AJCC v8 that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 33 participants, below the 151-participant average among 24 other Stage IV Renal Cell Cancer AJCC v8 trials with a reported enrollment target (78% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07128680, a Phase 1 study of Stage IV Renal Cell Cancer AJCC v8 and Stage III Renal Cell Cancer AJCC v8, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
IFNγ plasma concentration will be analyzed using a 2-sample t-test if normality assumptions are met; otherwise, the Wilcoxon rank sum test will be applied.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Bone Scan
- BIOLOGICAL Ipilimumab
- DIETARY_SUPPLEMENT Faecalibacterium prausnitzii-containing Bacterial Strain Formulation EXL01
Study Locations (2)
California
- City of Hope Medical Center - Duarte
- City of Hope Medical Center - Irvine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2026-04-01 |
| Est. Completion | 2028-08-25 |
| Phase | Phase 1 |
What NCT07128680 shows while recruiting
NCT07128680 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 151-participant average among 24 other Stage IV Renal Cell Cancer AJCC v8 trials with a reported enrollment target (78% lower).
The record links to 6 conditions, with Stage IV Renal Cell Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07128680 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT07128680 about?
NCT07128680 is a clinical study titled "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 nivol...
What is the current status of trial NCT07128680?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2026-04-01. Estimated completion is 2028-08-25.
What conditions does trial NCT07128680 study?
This clinical trial studies the following conditions: Stage IV Renal Cell Cancer AJCC v8, Stage III Renal Cell Cancer AJCC v8, Metastatic Clear Cell Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma, Metastatic Sarcomatoid Renal Cell Carcinoma.
What interventions are being tested in trial NCT07128680?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Bone Scan (PROCEDURE), Ipilimumab (BIOLOGICAL), Faecalibacterium prausnitzii-containing Bacterial Strain Formulation EXL01 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT07128680?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07128680 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IV Renal Cell Cancer AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07128680's enrollment target sits among peer trials
33 17th of 24 higher than 8 of 24 other Stage IV Renal Cell Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Renal Cell Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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