DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Fibrolamellar Hepatocellular Carcinoma

STATUS

Recruiting
participants needed

12
sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Send

Updated on 19 February 2024

See if I qualify

cancer

measurable disease

nivolumab

core needle biopsy

carcinoma

peptide vaccine

ipilimumab

hepatocellular carcinoma

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 to assess the T-cell response.

Details

Condition	Fibrolamellar Hepatocellular Carcinoma (FLC)
Age	12-100 years
Treatment	Nivolumab, Ipilimumab, DNAJB1-PRKACA peptide vaccine
Clinical Study Identifier	NCT04248569
Sponsor	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on	19 February 2024

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Must have histologically confirmed FLC (fibrolamellar hepatocellular cancer) that is metastatic or unresectable
	Presence of DNAJB1-PRKACA fusion transcript, assessed by RNA-sequencing in the archival tissue
	Age 12 years. Note: Subjects age 12 years but <18 are eligible to enroll only after 6 adult patients have enrolled on the study
	Patients < 18 years old must have a body weight 40 kg
	Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
	Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug
	Patients must have measurable disease per RECIST 1.1
	Patients 18 years old must have an accessible non-bone tumor lesion from which serial core biopsy specimens can be obtained
	Must be willing to provide tissue and blood samples for mandatory translational research
	Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol
	Men must use acceptable form of birth control while on study
	Ability to understand and willingness to sign a written informed consent document
Exclusion Criteria
	Have had chemotherapy or other systemic therapy or radiotherapy, as follows
	Have had chemotherapy, biological cancer therapy, or radiation 14 days prior to the first dose of study drug
	Have had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.), celiac plexus block, and biliary stent placement
	Have received other approved or investigational agents or device within 28 days of the first dose of study drug
	Have not recovered from acute adverse events to grade 1 or baseline due to agents administered
	Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.)
	Have received any non-oncology live vaccine therapy used for prevention of infectious diseases within 28 days of study treatment
	Known sensitivity to or history of allergic reactions to investigational drug (s)
	Hypersensitivity reaction to any monoclonal antibody
	Has active autoimmune disease that has required systemic treatment in the past 2 years, or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
	Presence of any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft. Patients with a history of allogeneic hematopoeitic stem cell transplant will be excluded
	Has a diagnosis of immunodeficiency
	Systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days of study drug administration
	Symptomatic interstitial lung disease
	Has a pulse oximetry of <92% on room air or is on supplemental home oxygen
	Active or untreated brain metastases or leptomeningeal metastases
	Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements
	Are pregnant or breastfeeding
	Infection with HIV or hepatitis B or C
	Have had evidence of active or acute diverticulitis, intra-abdominal abscess, or GI obstruction
	Unwilling or unable to follow the study schedule for any reason
	Any other sound medical, psychiatric, and/or social reason as determined by the Investigator
	Any illicit drugs or other substance abuse
	Clinically meaningful ascites

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

hepatocellular carcinoma

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Nivolumab and Ipilimumab for Patients With Fibrolamellar Hepatocellular Carcinoma