Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 1 study of Metastatic Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, sponsored by City of Hope Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Will be assessed for patients' stool sample
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 |
What the registry record for NCT05122546 still lists
NCT05122546 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 142-participant average among 37 other Metastatic Renal Cell Carcinoma trials with a reported enrollment target (78% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Metastatic Renal Cell Carcinoma
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 NCT05122546's enrollment target sits among peer trials
31 26th of 37 higher than 12 of 37 other Metastatic Renal Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Renal Cell Carcinoma 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer
RECRUITING · Phase 1
-
CBM588 Capsules in Combination With Nivolumab and Ipilimumab for the Treatment of Advanced Stage Kidney Cancer
RECRUITING · Phase 1
-
A Study of Abemaciclib and Cabozantinib in People With Clear Cell Renal Cell Carcinoma (ccRCC)
RECRUITING · Phase 1
-
Testing the PD-1 Antibody, MK3475, Given With Ziv-aflibercept in Patients With Advanced Cancer
ACTIVE NOT RECRUITING · Phase 1
-
NBTXR3 Activated by Radiotherapy for Patients With Advanced Cancers Treated With An Anti-PD-1 Therapy
ACTIVE NOT RECRUITING · Phase 1
-
UCDCC#272: IL-2, Radiotherapy, and Pembrolizumab in Patients Refractory to Checkpoint Blockade
ACTIVE NOT RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02932618 · 31 participants · Phase 3
A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)
- NCT03482297 · 31 participants · Phase 1
Automated Abdominal Binder for Orthostatic Hypotension
- NCT04016389 · 31 participants · NA
FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery
- NCT04211675 · 31 participants · Phase 1
NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI