Targeting Driver Oncogenes With a Peptide Vaccine Plus Durvalumab and Tremelimumab for Patients With Biliary Tract Cancers (BTC)
- Conditions
- Pancreatic Cancer
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria:<br><br> - Age =18 years<br><br> - Must have a histologically- or cytologically, proven biliary tract cancer (BTC)<br> previously treated with gemcitabine/cisplatin/anti-PD(L)1 therapy.<br><br> - Must have evidence of radiological disease, must accept to have a tumor biopsy of an<br> accessible lesion at baseline and on treatment.<br><br> - Must have sufficient archival tumor tissue for next-generation sequencing (NGS) and<br> immune-phenotyping.<br><br> - Have a BTC containing at least one of the oncogenic mutation/alterations targeted by<br> the vaccine.<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.<br><br> - Must have body weight of >30 kg.<br><br> - Patients must have adequate organ and marrow function defined by study-specified<br> laboratory tests.<br><br> - Patients with chronic or acute hepatitis B virus (HBV) or hepatitis C virus (HCV)<br> infection must have disease controlled prior to enrollment.<br><br> - Women of childbearing potential (WOCBP) must have a negative urine or serum<br> pregnancy test.<br><br> - For both Women and Men, must use acceptable form of birth control while on study.<br><br> - Must have a life expectancy of at least 12 weeks.<br><br> - Ability to understand and willingness to sign a written informed consent document.<br><br>Exclusion Criteria:<br><br> - Participation in another clinical study with an investigational product during the<br> last 2 weeks.<br><br> - Patient is expected to require any other form of systemic or localized<br> antineoplastic therapy while on study.<br><br> - Any of the following procedures or medications within 2 weeks prior to initiation of<br> study treatment:<br><br> - Systemic or topical steroids at immunosuppressive doses (> 10 mg/day of<br> prednisone or equivalent). The following are exceptions to this criterion:<br><br> - Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra<br> articular injection)<br><br> - Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of<br> prednisone or its equivalent<br><br> - Steroids as premedication for hypersensitivity reactions (e.g., CT scan<br> premedication)<br><br> - Palliative or adjuvant radiation or gamma knife radiosurgery.<br><br> - Chemotherapy or checkpoint inhibitor targeting anti-Pd1/PD-L1.<br><br> - Within 4 weeks prior to initiation of study treatment:<br><br> - Any investigational cytotoxic drug.<br><br> - Any investigational device.<br><br> - Non-oncology vaccines containing live virus.<br><br> - Allergen hyposensitization therapy.<br><br> - Growth factors, e.g. granulocyte-colony stimulating factor (G-CSF), granulocyte<br> macrophage-colony stimulating factor (GM-CSF), erythropoietin.<br><br> - Major surgery.<br><br> - Any unresolved toxicity NCI CTCAE Grade =2 from previous anticancer therapy with the<br> exception of alopecia, vitiligo, and the laboratory values defined in the inclusion<br> criteria.<br><br> - Patients with Grade =2 neuropathy will be evaluated on a case-by-case basis after<br> consultation with the Study Physician.<br><br> - All AEs while receiving prior immunotherapy must have completely resolved or<br> resolved to baseline prior to screening for this study.<br><br> - Must not have experienced a =Grade 3 immune related AE or an immune related<br> neurologic or ocular AE of any grade while receiving prior immunotherapy.<br><br> - Patients with a history of prior treatment with anti-PD-1 and anti-PD-L1.<br><br> - History of severe hypersensitivity reaction to any monoclonal antibodies or related<br> compounds or to any of its components.<br><br> - History of leptomeningeal carcinomatosis.<br><br> - Patient has a known history or evidence of brain metastases.<br><br> - Has an active known or suspected autoimmune disease or which has required systemic<br> therapy in the last 5 years.<br><br> - Known history of interstitial lung disease or of (non-infectious) pneumonitis that<br> required steroids or current pneumonitis.<br><br> - Has a pulse oximetry < 92% on room air.<br><br> - Requires the use of home oxygen.<br><br> - Has a known history of Human Immunodeficiency Virus (HIV)/AIDS<br><br> - Has active co-infection with HBV (hepatitis B virus) and HCV (hepatitis C virus) or<br> coinfected with HBV and hepatitis delta virus (HDV)<br><br> - Uncontrolled intercurrent illness including, but not limited to, uncontrolled<br> infection, symptomatic congestive heart failure, unstable angina, cardiac<br> arrhythmia, metastatic cancer, or psychiatric illness/social situations that would<br> limit compliance with study requirements.<br><br> - Patients who have been diagnosed with another cancer or myeloproliferative disorder<br> in the past 5 years requiring systemic therapy or expected to require active therapy<br> within the clinical study period.<br><br> - Has a diagnosis of immunodeficiency.<br><br> - Presence of any tissue or organ allograft, regardless of need for immunosuppression,<br> including corneal allograft. Patients with a history of allogeneic hematopoietic<br> stem cell transplant will be excluded.<br><br> - Any other sound medical, psychiatric, and/or social reason as determined by the<br> Investigator.<br><br> - Patient is at the time of signing informed consent a regular user (including<br> recreational use) of any illicit drugs or had a recent history (within the last<br> year) of substance abuse (including alcohol).<br><br> - Patient is unwilling or unable to follow the study schedule for any reason.<br><br> - Pregnant or breastfeeding.<br><br> - WOCBP and men with female partners (WOCBP) who are not willing to use contraception.<br><br> - Evidence of clinical ascites requiring paracentesis in the last 4 weeks.<br><br> - History of malignant bowel obstruction.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants experiencing grade 3 or above drug-related toxicities;Maximum percentage change in interferon-producing mutant-specific cluster of differentiation 8 (CD8) and cluster of differentiation 4 (CD4) T cells.
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS);Overall Survival (OS)