NCT04301778CompletedPhase 2
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.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 site in 1 country5 target enrollmentStarted: August 24, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Number of Participants Experiencing Study Drug-related Toxicities
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Durvalumab and SNDX-6352
Experimental
Participants will receive Durvalumab and SNDX-6352.
Intervention: Durvalumab (Drug)
Durvalumab and SNDX-6352
Experimental
Participants will receive Durvalumab and SNDX-6352.
Intervention: SNDX-6352 (Drug)
Outcomes
Primary Outcomes
Number of Participants Experiencing Study Drug-related Toxicities
Time Frame: up to 1 year
Number of participants who experience treatment related adverse events ≥ grade 3 as defined by CTCAE 5.0.
Objective Response Rate (ORR) Per mRECIST (Modified RECIST)
Time Frame: 8 months
ORR is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (mRECIST) at any time during the study. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \>20% increase in sum of diameters of target lesions, stable disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
Secondary Outcomes
- Overall Survival (OS)(up to 2 years)
- Progression-free Survival (PFS) Per mRECIST(8 months)
- Duration of Response (DOR)(8 months)
Investigators
Study Sites (1)
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