DNAJB1-PRKACA peptide vaccine for Fibrolamellar Hepatocellular Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Fibrolamellar Hepatocellular CarcinomaDNAJB1-PRKACA peptide vaccine - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer vaccine in people with a certain type of cancer that has spread or cannot be removed by surgery. The vaccine will be given with two other drugs, and the goal is to see if it is safe and causes T cells to respond.

Eligible Conditions
  • Fibrolamellar Hepatocellular Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 7 Secondary · Reporting Duration: 4 years

4 years
Disease control rate (DCR)
Duration of response (DoR)
Immune progression-free survival (irPFS)
Number of participants experiencing study drug-related toxicities
Objective response rate (ORR)
Overall survival (OS)
Progression-free survival (PFS)
iRECIST Objective response rate (iRORR)
Baseline and 10 weeks
Fold change in interferon-producing DNAJB1-PRKACA-specific cluster of differentiation 4 (CD4) T cells at 10 weeks
T-Lymphocyte

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

DNAJB1-PRKACA peptide vaccine, Nivolumab, and Ipilimumab
1 of 1

Experimental Treatment

12 Total Participants · 1 Treatment Group

Primary Treatment: DNAJB1-PRKACA peptide vaccine · No Placebo Group · Phase 1

DNAJB1-PRKACA peptide vaccine, Nivolumab, and IpilimumabExperimental Group · 3 Interventions: DNAJB1-PRKACA peptide vaccine, Ipilimumab, Nivolumab · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
FDA approved
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
536 Previous Clinical Trials
31,282 Total Patients Enrolled
Fibrolamellar Cancer FoundationUNKNOWN
1 Previous Clinical Trials
Bristol-Myers SquibbIndustry Sponsor
2,498 Previous Clinical Trials
3,930,805 Total Patients Enrolled
Mark Yarchoan, MDPrincipal InvestigatorJohns Hopkins Medical Institution
1 Previous Clinical Trials
20 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Presence of a fusion transcript in the tissue.
You are a woman of childbearing potential who has a negative pregnancy test and follows contraceptive guidelines as defined per protocol.
You have a performance status of 0 or 1.
You must be willing to provide tissue and blood samples for mandatory translational research.
References