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NCT06399419 · ClinicalTrials.gov registry record · Phase 1
CBM588 Capsules in Combination With Nivolumab and Ipilimumab for the Treatment of Advanced Stage Kidney Cancer
A Phase 1 study of Metastatic Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, sponsored by Osel.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT06399419: Recruiting Phase 1 study of Metastatic Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, sponsored by Osel.
NCT06399419 is a Phase 1 study of Metastatic Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8 that is actively recruiting participants, run by Osel. The registered enrollment target is 28 participants, below the 143-participant average among 37 other Metastatic Renal Cell Carcinoma trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06399419, a Phase 1 study of Metastatic Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, is actively recruiting participants, sponsored by Osel.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial tests the safety, side effects, best dose, and effectiveness of CBM588 in combination with nivolumab and ipilimumab in treating patients with kidney cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). CBM588 is a live biotherapeutic that may help improve the effects of immunotherapy. Nivolumab and ipilimumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread by enhancing the ability of the body's immune cells to attack tumor cells. CBM588 in combination with nivolumab and ipilimumab may be safe, tolerable, and/or effective in treating patients with advanced stage kidney cancer.
Primary Outcome
Toxicities at least possibly related to study agent will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Bone Scan
- BIOLOGICAL Ipilimumab
- BIOLOGICAL CBM588 Capsules
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2024-06-19 |
| Est. Completion | 2026-10-19 |
| Phase | Phase 1 |
What NCT06399419 shows while recruiting
NCT06399419 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 143-participant average among 37 other Metastatic Renal Cell Carcinoma trials with a reported enrollment target (80% lower).
The record links to 8 conditions, with Metastatic Renal Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06399419 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06399419 about?
NCT06399419 is a clinical study titled "CBM588 Capsules in Combination With Nivolumab and Ipilimumab for the Treatment of Advanced Stage Kidney Cancer". This phase I trial tests the safety, side effects, best dose, and effectiveness of CBM588 in combination with nivolumab and ipilimumab in treating patients with kidney cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). CBM5...
What is the current status of trial NCT06399419?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2024-06-19. Estimated completion is 2026-10-19.
What conditions does trial NCT06399419 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 NCT06399419?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Bone Scan (PROCEDURE), Ipilimumab (BIOLOGICAL), CBM588 Capsules (BIOLOGICAL).
Who is sponsoring clinical trial NCT06399419?
This trial is sponsored by Osel, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06399419 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
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Where NCT06399419's enrollment target sits among peer trials
28 29th of 37 higher than 9 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.
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