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Durvalumab in Combination With a CSF-1R Inhibitor (SNDX-6532) Following Chemo or Radio-Embolization for Patients With Intrahepatic Cholangiocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04301778
Recruitment Status : Not yet recruiting
First Posted : March 10, 2020
Last Update Posted : July 14, 2020
Sponsor:
Collaborators:
Syndax Pharmaceuticals
AstraZeneca
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Condition or disease Intervention/treatment Phase
Unresectable Intrahepatic Cholangiocarcinoma Drug: Durvalumab Drug: SNDX-6352 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024


Arm Intervention/treatment
Experimental: Durvalumab and SNDX-6352
Participants will receive Durvalumab and SNDX-6352.
Drug: Durvalumab
  1. Durvalumab - 1500 mg via IV infusion over 60 minutes (-5/+10 min) on day 1 of each 28-day cycle (every 4 weeks).
  2. Drug - 1500mg IV
Other Name: MEDI4736

Drug: SNDX-6352
  1. 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).
  2. Drug - 3mg/kg IV
Other Name: UCB6352




Primary Outcome Measures :
  1. Objective Response Rate (ORR) per mRECIST (modified RECIST) [ Time Frame: 4 years ]
    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.

  2. Number of participants experiencing study drug-related toxicities [ Time Frame: 4 years ]
    When calculating the incidence of Adverse Events (AEs), each AE (as defined by NCI CTCAE v5.0) will be counted only once for a given subject.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04301778


Contacts
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Contact: Susan Sartorius-Mergenthaler, RN 410-614-3644 Sartosu@jhmi.edu
Contact: Ellen Lilly-Forman, RN 443-287-4961 lillyel@jhmi.edu

Locations
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United States, Maryland
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231
Contact: Susan Sartorius-Mergenthaler, RN    410-614-3644    Sartosu@jhmi.edu   
Contact: Ellen Foreman-Lilly, RN    443-287-4961    lillyel@jhmi.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Syndax Pharmaceuticals
AstraZeneca
Investigators
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Principal Investigator: Lei Zheng, MD Sidney Kimmel Cancer Center at the Johns Hopkins Medical Institution
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT04301778    
Other Study ID Numbers: J2031
IRB00233351 ( Other Identifier: Johns Hopkins Institutional Review Board )
First Posted: March 10, 2020    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Intrahepatic Cholangiocarcinoma
Durvalumab
SNDX-6352 (humanized immunoglobulin G (IgG) 4 monoclonal antibody (mAb))
colony stimulating factor (CSF)-1R inhibitor
colony stimulating factor-1 _CSF-1R)
Anti-PD-1 (receptor blocking antibody)
PD-1 (receptor blocking antibody)
PD-L1 (receptor blocking antibody)
Immunotherapy
Intra-arterial therapy
Y90 (yttrium-90 radioembolization)
conventional transarterial chemoembolization (cTACE)
Chemo-embolization
Radio-embolization
Biliary tract
Monoclonal antibody
Additional relevant MeSH terms:
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Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Durvalumab
Antineoplastic Agents, Immunological
Antineoplastic Agents