Durvalumab and SNDX-6532 Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma
Condition: Unresectable Intrahepatic Cholangiocarcinoma
MeSH terms: Cholangiocarcinoma
Intervention: Durvalumab; SNDX-6352
Intervention description: Durvalumab - 1500 mg via IV infusion over 60 minutes (-5/+10 min) on day 1 of each 28-day cycle (every 4 weeks).
Drug - 1500mg IV; SNDX-6352 - 3mg/kg via IV infusion over 30 minutes (-5/+10 min) on days 1 and 15 of each 28-day cycle (every 2 weeks), starting with cycle 2 (not given during cycle 1).
Drug - 3mg/kg IV
Intervention MeSH terms: Durvalumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
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

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.