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NCT05498792 · ClinicalTrials.gov registry record · Early Phase 1
Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma
A Early Phase 1 study of Locally Advanced or Metastatic Melanoma, sponsored by Fox Chase Cancer Center.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT05498792: Recruiting Early Phase 1 study of Locally Advanced or Metastatic Melanoma, sponsored by Fox Chase Cancer Center.
NCT05498792 is a Early Phase 1 study of Locally Advanced or Metastatic Melanoma that is actively recruiting participants, run by Fox Chase Cancer Center. The registered enrollment target is 12 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05498792, a Early Phase 1 study of Locally Advanced or Metastatic Melanoma, is actively recruiting participants, sponsored by Fox Chase Cancer Center.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
Phase I, open label, dose-escalation, and safety study designed to assess the safety and biologic activity of the investigational agent CBL0137 in combination with standard of care drugs, ipilimumab and nivolumab in sequential cohorts of adult patients with locally advanced and metastatic melanoma who are candidates for immune checkpoint blockade and have tumors accessible for serial biopsies.
Primary Outcome
The primary endpoint will be safety/tolerability of the combination of CBL0137 with ipilimumab and nivolumab. Patients will be treated as part of assigned dose level in planned 3+ 3 design with 3 possible dose levels and assessed for Dose limiting toxicities ( DLTs)
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG CBL0137
Study Locations (1)
Pennsylvania
- Fox Chase Cancer Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-11-30 |
| Est. Completion | 2026-09-02 |
| Phase | Early Phase 1 |
What NCT05498792 shows while recruiting
NCT05498792 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Locally Advanced or Metastatic Melanoma appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT05498792 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05498792 about?
NCT05498792 is a clinical study titled "Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma". Phase I, open label, dose-escalation, and safety study designed to assess the safety and biologic activity of the investigational agent CBL0137 in combination with standard of care drugs, ipilimumab and nivolumab in sequential cohorts of adult patients with locally advanced and metastatic melanoma w...
What is the current status of trial NCT05498792?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2022-11-30. Estimated completion is 2026-09-02.
What conditions does trial NCT05498792 study?
This clinical trial studies the following conditions: Locally Advanced or Metastatic Melanoma.
What interventions are being tested in trial NCT05498792?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), CBL0137 (DRUG).
Who is sponsoring clinical trial NCT05498792?
This trial is sponsored by Fox Chase Cancer Center, which has 183 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05498792 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05498792's enrollment target sits among peer trials
12 1530th of 2000 higher than 401 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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
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