- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04301778
Durvalumab and SNDX-6532 Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma
February 14, 2024 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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.
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Maryland
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Baltimore, Maryland, United States, 21231
- Sidney Kimmel Comprehensive Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Durvalumab and SNDX-6352
Participants will receive Durvalumab and SNDX-6352.
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Other Names:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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8 months
|
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.
|
up to 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of Response (DOR)
Time Frame: 4 years
|
Number of weeks from the start date of PR or CR (whichever response is recorded first) and subsequently confirmed to the first date that recurrent or progressive disease or death is documented.
Per mRECIST, CR = disappearance of any intratumoral arterial enhancement in all target lesions, PR is =>30% decrease in sum of diameters of target lesions.
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4 years
|
Overall Survival (OS)
Time Frame: 4 years
|
OS will be measured from date of first dose until death or end of followup (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis).
Estimation based on the Kaplan-Meier curve.
|
4 years
|
Progression-free Survival (PFS) Per mRECIST
Time Frame: 4 years
|
PFS is defined as the number of months from the date of treatment to disease recurrence [disease recurrence (DR) progressive disease (PD) or relapse from complete response (CR) as assessed using mRECIST criteria] or death due to any cause.
Per mRECIST criteria, CR = disappearance of all target lesions, Partial Response (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.
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4 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lei Zheng, MD, Sidney Kimmel Cancer Center at the Johns Hopkins Medical Institution
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 24, 2021
Primary Completion (Actual)
November 4, 2022
Study Completion (Actual)
February 6, 2024
Study Registration Dates
First Submitted
March 6, 2020
First Submitted That Met QC Criteria
March 6, 2020
First Posted (Actual)
March 10, 2020
Study Record Updates
Last Update Posted (Actual)
February 20, 2024
Last Update Submitted That Met QC Criteria
February 14, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
- Monoclonal antibody
- Immunotherapy
- Intrahepatic Cholangiocarcinoma
- Anti-PD-1 (receptor blocking antibody)
- Intra-arterial therapy
- Y90 (yttrium-90 radioembolization)
- conventional transarterial chemoembolization (cTACE)
- Chemo-embolization
- Radio-embolization
- Biliary tract
- colony stimulating factor -1 receptor (CSF-1R) inhibitor
Additional Relevant MeSH Terms
Other Study ID Numbers
- J2031
- IRB00233351 (Other Identifier: Johns Hopkins Institutional Review Board)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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