RecruitingPhase 1

Targeting Driver Oncogenes With a Peptide Vaccine Plus Durvalumab and Tremelimumab for Patients With Biliary Tract Cancers (BTC)

A Pilot Study of Targeting Driver Oncogenes With a Peptide Vaccine Plus Durvalumab and Tremelimumab for Patients With Biliary Tract Cancers

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a personal cancer vaccine called mBTCvax with durvalumab and tremelimumab after first treatment for advanced biliary tract cancer. It checks safety and how the immune system responds. Biliary tract cancer affects the bile ducts or gallbladder.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old and weigh more than 30 kg (about 66 pounds).
  • Have biliary tract cancer confirmed by tissue or cell tests, with cancer visible on scans.
  • Have had gemcitabine, cisplatin, and anti-PD(L)1 treatment. Note: the exclusion list also rules out prior anti-PD-1 or anti-PD-L1 treatment; ask the study team to clarify.
  • Have a cancer gene change targeted by the vaccine and enough stored tumor tissue for testing.
  • Agree to tumor biopsies—removal of small tissue samples—before and during treatment.
  • Be fully active or able to do light work. Have suitable organ and blood cell test results and be expected to live at least 12 weeks.
  • Have hepatitis B or C under control, if present. Use accepted birth control and have a negative pregnancy test if able to become pregnant.
  • Be able to understand the study and willing to sign a consent form.

Who can't join

  • Have certain recent treatments: another study drug within 2 weeks; certain steroids, radiation, chemotherapy, or immune treatments within 2 weeks; or certain study drugs or devices, live-virus vaccines, allergy treatments, blood cell growth medicines, or major surgery within 4 weeks. Some steroid uses are allowed.
  • Need other cancer treatment during the study, or have lasting treatment side effects beyond the allowed limits. Prior severe immune side effects, or immune side effects affecting the nerves or eyes, also rule out joining.
  • Have a history of severe allergy to antibody medicines or their ingredients, or cancer that has spread to the brain or its surrounding tissues.
  • Have certain immune system illnesses, HIV/AIDS, an organ or tissue transplant, or a stem cell transplant from another person. Certain combinations of hepatitis infections also rule out joining.
  • Have certain lung diseases or lung inflammation, blood oxygen below 92% without added oxygen, need home oxygen, or have an uncontrolled illness that could prevent study participation.
  • Have another cancer or a disorder that makes too many blood cells requiring drug treatment within the past 5 years or expected to need treatment during the study. Fluid buildup in the belly drained within 4 weeks, or a history of bowel blockage caused by cancer, also rules out joining.
  • Be pregnant or breastfeeding, or be unwilling to use required birth control.
  • Regularly use illegal drugs, have alcohol or drug abuse within the past year, or be unable or unwilling to follow the study schedule. Other medical, mental health, or social concerns may also prevent joining.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

MD