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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 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. The trial reports 1 study location across 1 state.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04248569
The ClinicalTrials.gov registry entry for NCT04248569 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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