Is NCT06564623 recruiting in Baltimore, MD?

Yes, NCT06564623 is currently recruiting participants at its Baltimore, MD location. This biliary tract cancers clinical trial is actively enrolling qualified participants.

How do I join the biliary tract cancers clinical trial in Baltimore?

To join this clinical trial in Baltimore, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Baltimore clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Biliary Tract Cancers Clinical Trial in Baltimore, MD

About This Biliary Tract Cancers Study in Baltimore

The purpose of this study is to evaluate the safety and the immune response of personalized mutant peptide vaccine with poly-ICLC adjuvant (mBTCvax) in combination with durvalumab and tremelimumab following front-line treatment in patients with advanced stage BTC.

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Who Can Participate

Inclusion Criteria

Age ≥18 years

Must have a histologically- or cytologically, proven biliary tract cancer (BTC) previously treated with gemcitabine/cisplatin/anti-PD(L)1 therapy.

Must have evidence of radiological disease, must accept to have a tumor biopsy of an accessible lesion at baseline and on treatment.

Must have sufficient archival tumor tissue for next-generation sequencing (NGS) and immune-phenotyping.

Have a BTC containing at least one of the oncogenic mutation/alterations targeted by the vaccine.

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

Must have body weight of \>30 kg.

Patients must have adequate organ and marrow function defined by study-specified laboratory tests.

Patients with chronic or acute hepatitis B virus (HBV) or hepatitis C virus (HCV) infection must have disease controlled prior to enrollment.

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.

Must have a life expectancy of at least 12 weeks.

Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria

Participation in another clinical study with an investigational product during the last 2 weeks.

Patient is expected to require any other form of systemic or localized antineoplastic therapy while on study.

Any of the following procedures or medications within 2 weeks prior to initiation of study treatment:

Systemic or topical steroids at immunosuppressive doses (\> 10 mg/day of prednisone or equivalent). The following are exceptions to this criterion:

Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)

Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent

Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)

Palliative or adjuvant radiation or gamma knife radiosurgery.

Chemotherapy or checkpoint inhibitor targeting anti-Pd1/PD-L1.

Within 4 weeks prior to initiation of study treatment:

Any investigational cytotoxic drug.

Any investigational device.

Non-oncology vaccines containing live virus.

Allergen hyposensitization therapy.

Growth factors, e.g. granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin.

Major surgery.

Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.

Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.

All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.

Must not have experienced a ≥Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy.

Patients with a history of prior treatment with anti-PD-1 and anti-PD-L1.

History of severe hypersensitivity reaction to any monoclonal antibodies or related compounds or to any of its components.

History of leptomeningeal carcinomatosis.

Patient has a known history or evidence of brain metastases.

Has an active known or suspected autoimmune disease or which has required systemic therapy in the last 5 years.

Known history of interstitial lung disease or of (non-infectious) pneumonitis that required steroids or current pneumonitis.

Has a pulse oximetry \< 92% on room air.

Requires the use of home oxygen.

Has a known history of Human Immunodeficiency Virus (HIV)/AIDS

Has active co-infection with HBV (hepatitis B virus) and HCV (hepatitis C virus) or coinfected with HBV and hepatitis delta virus (HDV)

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.

Patients who have been diagnosed with another cancer or myeloproliferative disorder in the past 5 years requiring systemic therapy or expected to require active therapy within the clinical study period.

Has a diagnosis of immunodeficiency.

Presence of any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft. Patients with a history of allogeneic hematopoietic stem cell transplant will be excluded.

Any other sound medical, psychiatric, and/or social reason as determined by the Investigator.

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).

Patient is unwilling or unable to follow the study schedule for any reason.

Pregnant or breastfeeding.

WOCBP and men with female partners (WOCBP) who are not willing to use contraception.

Evidence of clinical ascites requiring paracentesis in the last 4 weeks.

History of malignant bowel obstruction.

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 (NCT06564623) 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.

Biliary Tract Cancers Treatment Options in Baltimore, MD

If you're searching for biliary tract cancers treatment options in Baltimore, MD, this clinical trial (NCT06564623) 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 clinical trial. You'll receive care from experienced biliary tract cancers 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 biliary tract cancers clinical trials near you to find additional studies recruiting in your area.

Biliary Tract Cancers Clinical Trial in Baltimore, MD

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