durvalumab and sndx-6532 following chemo or radio-embolization for patients with intrahepatic cholangiocarcinoma

Conditions: Unresectable Intrahepatic Cholangiocarcinoma

Summary: the purposed of this research is to study the safety and clinical activity of the combination of durvalumab and a csf-1r inhibitor (sndx-6352) in people with intrahepatic cholangiocarcinoma.


Eligibility criteria:
inclusion criteria: * have cytologically confirmed intrahepatic cholangiocarcinoma. * all disease must be localized to the liver (locally advanced). * subjects must not be deemed surgical candidates. * must be a candidate for conventional transarterial chemoembolization or yttrium-90 radioembolization. * must have measureable disease be mrecist. measurable disease will be confirmed by radiological imaging (mri, ct). * age ≥18 years * body weight \> 30 kg * eastern cooperative oncology group (ecog) performance status 0 or 1 * life expectancy ≥12 weeks. * patient must have adequate organ function defined by the study-specified laboratory tests as per the protocol. * child pugh class a * measured creatinine clearance (cl) \>40 ml/min or calculated creatinine clearance cl\>40 ml/min by the cockcroft-gault formula. * woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol. * must use acceptable form of birth control while on study. * men must use acceptable form of birth control while on study. * ability to understand and willingness to sign a written informed consent document. * willing and able to comply with the protocol for the duration of the study exclusion criteria: * candidate for surgical resection * concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up of an interventional study. * major surgery within 4 weeks prior to initiation of study treatment. * received the last dose of anticancer therapy ≤ 28 days prior to the first dose of study drug. * all toxicities nci ctcae grade ≥2 attributed to prior anti-cancer therapy other than alopecia, vitiligo, and neuropathy. * any concurrent chemotherapy, ip, biologic, or hormonal therapy for cancer treatment. * history of allogenic organ transplantation. * active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, sarcoidosis syndrome, checkpoint inhibitor-induced immune mediated reaction or wegener syndrome \[granulomatosis with polyangiitis, graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\]). * patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant muscle disorders or psychiatric illness/social situations that would limit compliance with study requirements. * history of known additional primary malignancies. * history of leptomeningeal carcinomatosis. * brain metastases or spinal cord compression. * history of active primary immunodeficiency. * infection with tuberculosis, hiv or hepatitis b or c at screening. * current or prior use of immunosuppressive medication within 14 days before the first dose of treatment. * receipt of live attenuated vaccine within 30 days prior to the first dose of ip. * pregnant or breastfeeding women. * has a history of allergy to study treatments or any of its components of the study. * prior randomization or treatment in a previous durvalumab and/or sndx-6532 clinical study regardless of treatment arm assignment. * patient has clinically significant heart disease. * any other sound medical, psychiatric, and/or social reason as determined by the investigator. * unwilling or unable to follow the study schedule for any reason.

Keywords: colony stimulating factor -1 receptor (csf-1r) inhibitor anti-pd-1 (receptor blocking antibody) immunotherapy intra-arterial therapy y90 (yttrium-90 radioembolization) conventional transarterial chemoembolization (ctace) chemo-embolization radio-embolization biliary tract intrahepatic cholangiocarcinoma monoclonal antibody