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NCT05122546 · ClinicalTrials.gov registry record · Phase 1
CBM588 in Combination With Nivolumab and Cabozantinib for the Treatment of Advanced or Metastatic Kidney Cancer
A Phase 1 study of Metastatic Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT05122546 is a Phase 1 study of Metastatic Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8 that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 31 participants, below the 142-participant average among 37 other Metastatic Renal Cell Carcinoma trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05122546, a Phase 1 study of Metastatic Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial evaluates the effects of CBM588 in combination with standard therapies, nivolumab and cabozantinib, in treating patients with kidney cancer that has spread to other places in the body (advanced/metastatic). The digestive microbiome may have an effect on how patients respond to treatment, and previous research shows that a specific bacteria found in the gut (Bifidobacterium) may predispose participants to a better response to standard therapies. CBM588 is a strain of bacteria that can restore species of Bifidobacterium to the microbiome. The primary aim of this study is to determine how CBM588 changes the microbiome of patients with metastatic renal cell carcinoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving CBM588, nivolumab, and cabozantinib may kill more tumor cells.
Conditions Studied
Interventions
- DRUG Cabozantinib S-malate
- BIOLOGICAL Nivolumab
- DRUG Clostridium butyricum CBM 588 Probiotic Strain
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2021-11-01 |
| Est. Completion | 2027-01-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05122546
The ClinicalTrials.gov registry entry for NCT05122546 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 142-participant average among 37 other Metastatic Renal Cell Carcinoma trials with a reported enrollment target (78% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Metastatic Renal Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Cabozantinib S-malate is the first listed.
NCT05122546 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05122546 about?
NCT05122546 is a clinical study titled "CBM588 in Combination With Nivolumab and Cabozantinib for the Treatment of Advanced or Metastatic Kidney Cancer". This phase I trial evaluates the effects of CBM588 in combination with standard therapies, nivolumab and cabozantinib, in treating patients with kidney cancer that has spread to other places in the body (advanced/metastatic). The digestive microbiome may have an effect on how patients respond to tre...
What is the current status of trial NCT05122546?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2021-11-01. Estimated completion is 2027-01-12.
What conditions does trial NCT05122546 study?
This clinical trial studies the following conditions: Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8, Stage III Renal Cell Cancer AJCC v8, Metastatic Clear Cell Renal Cell Carcinoma, Advanced Renal Cell Carcinoma.
What interventions are being tested in trial NCT05122546?
The interventions under investigation include: Cabozantinib S-malate (DRUG), Nivolumab (BIOLOGICAL), Clostridium butyricum CBM 588 Probiotic Strain (DRUG).
Who is sponsoring clinical trial NCT05122546?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05122546 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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