Baltimore, MDNCT07430202Now EnrollingIRB Ready

Liver Cancer (Fibrolamellar Hepatocellular Cancer (FLC)) Clinical Trial in Baltimore, MD

Access cutting-edge liver cancer (fibrolamellar hepatocellular cancer (flc)) treatment through this phase 1 clinical trial at a research site in Baltimore. Study-provided care at no cost to qualified participants.

Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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Expert Care in Baltimore

Access liver cancer (fibrolamellar hepatocellular cancer (flc)) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related liver cancer (fibrolamellar hepatocellular cancer (flc)) treatment provided free

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Check if you qualify for this liver cancer (fibrolamellar hepatocellular cancer (flc)) clinical trial in Baltimore, MD

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Why Participate?

  • No-Cost Study Care

  • Local to Baltimore

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Baltimore site if eligible
  4. 4Begin participation

About This Liver Cancer (Fibrolamellar Hepatocellular Cancer (FLC)) Study in Baltimore

The purpose of this study is to determine whether the combination of a neoantigen vaccine targeting the DNAJB1-PRKACA fusion kinase in combination with DRP-104, Nivolumab and Ipilimumab is safe and yields a clinically compelling antitumor activity measured as based on objective response rate (ORR, assessed by RECIST 1.1). Secondary objectives include progression-free survival (PFS) and overall survival (OS).

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Who Can Participate

Inclusion Criteria

Must have histologically confirmed FLC that is metastatic or unresectable.
Presence of DNAJB1-PRKACA fusion transcript, assessed by RNA-sequencing, DNA-sequencing, or in situ hybridization in the archival tissue.
Must have demonstrated radiographic progression on prior or current immunotherapy.
Age ≥ 12 years.
Patients \< 18 years old must have a body weight ≥ 40 kg.
ECOG (Eastern Cooperative Oncology Group) performance status of ≤2
Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
Patients must have adequate kidney and liver function defined by study-specified laboratory tests.
Must have measurable disease per RECIST 1.1
Willingness to provide tissue and blood samples for mandatory translational research.
Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test.
For both Women and 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

Patients with a history of prior treatment with checkpoint inhibitors, such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, anti-CTLA-4, or anti-LAG-3 antibodies.
Must have had chemotherapy or other systemic therapy or radiotherapy, as follows:
Patients who have had chemotherapy, biological cancer therapy, or radiation 14 days prior to the first dose of study drug.
Patients who have had surgery within 28 days of dosing of investigational agent, excluding minor procedures.
Patients who have received other approved or investigational agents or device within 28 days of the first dose of study drug.
Patients who have not recovered from acute adverse events to grade ≤1 or baseline due to agents administered, with exception of grade 2 fatigue, rash, and endocrinopathy successfully managed hormone replacement therapy, or alopecia or stable neuropathy, unless approved by the IND Sponsor.
Patients who 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 attributed to compounds of similar chemical or biologic composition of polyinosinic-polycytidylic acid (Poly-ICLC) and/or DRP-104 and/or nivolumab and/or ipilimumab.
History of severe hypersensitivity reaction to any monoclonal antibody.
Has an active autoimmune disease.
Prior allogeneic stem cell transplantation or organ transplantation.
Has a diagnosis of immunodeficiency.
Systemic corticosteroids at immunosuppressive doses.
Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.
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 active medical and/or psychiatric illness/social psychosocial problems that that would limit compliance with study requirements.
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.
Pregnant or breastfeeding.
Has a known history of Human Immunodeficiency Virus (HIV)/AIDS.
Has active hepatitis B. Patients with chronic or acute HBV infection.
Have had evidence of active or acute diverticulitis, intra-abdominal abscess, or GI obstruction which are known risk factors for bowel perforation should be evaluated for the potential need for additional treatment before coming on study.
Unwilling or unable to follow the study schedule for any reason.
Patient is at the time of signing informed consent a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).
Evidence of clinical ascites.
Patients with QTc prolongation \> 470 ms according to Fridericia formula.
Patients receiving potent inducers of CYP 3A4/5 (including but not limited to apalutamide, carbamazepine, enzalutamide, mitotane, phenytoin, rifampin and St. John's Wort) who cannot safely discontinue drug at least 14 days prior to Cycle 1 Day 1.
Have had an allergen hyposensitization therapy within 2 weeks prior to initiation of study treatment.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Baltimore?

Yes, this clinical trial (NCT07430202) has an active research site in Baltimore, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Liver Cancer (Fibrolamellar Hepatocellular Cancer (FLC)) Treatment Options in Baltimore, MD

If you're searching for liver cancer (fibrolamellar hepatocellular cancer (flc)) treatment options in Baltimore, MD, this clinical trial (NCT07430202) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Baltimore research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced liver cancer (fibrolamellar hepatocellular cancer (flc)) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all liver cancer (fibrolamellar hepatocellular cancer (flc)) clinical trials near you to find additional studies recruiting in your area.

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