Clinical trial NCT04301778: Durvalumab and SNDX-6532 Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma
Official title: A Phase II Study of Durvalumab (MEDI4736) in Combination With a CSF-1R Inhibitor (SNDX-6532) Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Unresectable Intrahepatic Cholangiocarcinoma
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
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Syndax Pharmaceuticals
name: AstraZeneca
First posted: 2020-03-10
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Objective Response Rate (ORR) Per mRECIST (Modified RECIST)
timeFrame: 8 months
measure: Number of Participants Experiencing Study Drug-related Toxicities
timeFrame: up to 1 year
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: up to 2 years
measure: Progression-free Survival (PFS) Per mRECIST
timeFrame: 8 months
measure: Duration of Response (DOR)
timeFrame: 8 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center
state: Maryland
Study officials:
affiliation: Sidney Kimmel Cancer Center at the Johns Hopkins Medical Institution
name: Lei Zheng, MD
role: PRINCIPAL_INVESTIGATOR
References: