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NCT04248569 · ClinicalTrials.gov registry record · Phase 1
DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Fibrolamellar Hepatocellular Carcinoma
A Phase 1 study of Fibrolamellar Hepatocellular Carcinoma (FLC), sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT04248569: Recruiting Phase 1 study of Fibrolamellar Hepatocellular Carcinoma (FLC), sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT04248569 is a Phase 1 study of Fibrolamellar Hepatocellular Carcinoma (FLC) that is actively recruiting participants, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 56 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04248569, a Phase 1 study of Fibrolamellar Hepatocellular Carcinoma (FLC), is actively recruiting participants, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of the trial is the safety and tolerability of administering a vaccine targeting the DNAJB1-PRKACA fusion kinase, in combination with nivolumab and ipilimumab in patients with unresectable or metastatic FLC and with non-FLC solid tumors and to assess the T-cell response.
Primary Outcome
Number of participants experiencing study drug-related adverse events Grade 3 or higher as defined by CTCAE v5.0
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG DNAJB1-PRKACA peptide vaccine
Study Locations (1)
Maryland
- Sidney Kimmel Comprehensive Cancer Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2020-04-20 |
| Est. Completion | 2034-03-01 |
| Phase | Phase 1 |
What NCT04248569 shows while recruiting
NCT04248569 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 1 condition, with Fibrolamellar Hepatocellular Carcinoma (FLC) appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT04248569 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04248569 about?
NCT04248569 is a clinical study titled "DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Fibrolamellar Hepatocellular Carcinoma". The primary objective of the trial is the safety and tolerability of administering a vaccine targeting the DNAJB1-PRKACA fusion kinase, in combination with nivolumab and ipilimumab in patients with unresectable or metastatic FLC and with non-FLC solid tumors and to assess the T-cell response.
What is the current status of trial NCT04248569?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2020-04-20. Estimated completion is 2034-03-01.
What conditions does trial NCT04248569 study?
This clinical trial studies the following conditions: Fibrolamellar Hepatocellular Carcinoma (FLC).
What interventions are being tested in trial NCT04248569?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), DNAJB1-PRKACA peptide vaccine (DRUG).
Who is sponsoring clinical trial NCT04248569?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04248569 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04248569's enrollment target sits among peer trials
56 903rd of 2000 higher than 1,083 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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