Clinical Trials /

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

NCT04301778

Description:

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.

Related Conditions:
  • Intrahepatic Cholangiocarcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Durvalumab in Combination With a CSF-1R Inhibitor (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.

Clinical Trial IDs

  • ORG STUDY ID: J19XXX
  • SECONDARY ID: IRB00233351
  • NCT ID: NCT04301778

Conditions

  • Unresectable Intrahepatic Cholangiocarcinoma

Interventions

DrugSynonymsArms
DurvalumabMEDI4736Durvalumab and SNDX-6352
SNDX-6352UCB6352Durvalumab and SNDX-6352

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Durvalumab and SNDX-6352ExperimentalParticipants will receive Durvalumab and SNDX-6352.
  • Durvalumab
  • SNDX-6352

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate (ORR) per mRECIST (modified RECIST)
Time Frame:4 years
Safety Issue:
Description: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 Outcome Measures

Measure:Overall survival (OS)
Time Frame:4 years
Safety Issue:
Description: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.
Measure:Progression-free Survival (PFS) per mRECIST
Time Frame:4 years
Safety Issue:
Description: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.
Measure:Duration of Response (DOR)
Time Frame:4 years
Safety Issue:
Description: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.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Trial Keywords

  • 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
  • Intrahepatic Cholangiocarcinoma
  • Monoclonal antibody

Last Updated

March 6, 2020