Study of Pembrolizumab in Metastatic Biliary Tract Cancer as Second-line Treatment After Failing to at Least One Cytotoxic Chemotherapy Regimen: Integration of Genomic Analysis to Identify Predictive Molecular Subtypes

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Brief Title

Study of Pembrolizumab in Metastatic Biliary Tract Cancer as Second-line Treatment After Failing to at Least One Cytotoxic Chemotherapy Regimen: Integration of Genomic Analysis to Identify Predictive Molecular Subtypes

Official Title

Phase II Study of Pembrolizumab in Metastatic Biliary Tract Cancer as Second-line Treatment After Failing to at Least One Cytotoxic Chemotherapy Regimen: Integration of Genomic Analysis to Identify Predictive Molecular Subtypes

Brief Summary

      eligible subjects will receive treatment beginning on Day 1 of each 3-week dosing cycle for
      pembrolizumab. Treatment with pembrolizumab will continue until documented disease
      progression, unacceptable adverse event(s),intercurrent illness that prevents further
      administration of treatment, Investigator's decision to withdraw the subject, subject
      withdraws consent, pregnancy of the subject, noncompliance with trial treatment or procedure
      requirements, subject receives 24 months of pembrolizumab, or administrative reasons
      requiring cessation of treatment.
    

Detailed Description

      This is a single-arm, single-center, open-label trial of pembrolizumab (MK-3475) in subjects
      with metastatic biliary tract cancer as second-line treatment after failing to at least one
      cytotoxic chemotherapy regimen

      Approximately 33 subjects will be enrollment to evaluate the efficacy and safety of
      pembrolizumab.

      Enrollment will begin with all subjects without regard for PD-L1 expression status.

      An evaluable specimen for PD-L1 status must be available and confirmed prior to enrollment.

      All study subjects will be evaluated every 6 weeks (+/- 7 days) following the date of IP drug
      adminstration for the first six months and every 12 weeks (+/- 7 days) thereafter until
      progression of disease is documented with radiologic imaging (computed tomography or magnetic
      resonance imaging).

      The primary efficacy endpoint is ORR (objective response rate) per RECIST 1.1. If a subject
      has progression of disease by RECIST 1.1, it is recommended that the subject be discontinued
      from the study treatment unless, in the Investigator's opinion, the subject is deriving
      benefit from treatment.

      Adverse events will be monitored throughout the trial and graded in severity according to the
      guidelines outlined in the NCI Common Terminology Criteria for Adverse Events (CTCAE) version
      4.0.

      Except as noted above, treatment with pembrolizumab will continue until documented disease
      progression, unacceptable adverse event(s), intercurrent illness that prevents further
      administration of treatment, Investigator's decision to withdraw the subject, subject
      withdraws consent, pregnancy of the subject, noncompliance with trial treatment or procedure
      requirements, completion of 24 months of pembrolizumab, or administrative reasons requiring
      the cessation of treatment.

      After the end of treatment, each subject will be followed for 30 days for adverse event
      monitoring (serious adverse events and events of clinical interest will be collected for 90
      days after the end of treatment or 30 days after the end of treatment if the subject
      initiates new anticancer therapy, whichever is earlier).Subjects who discontinue treatment
      for reasons other than disease progression will have post-treatment follow-up for disease
      status until disease progression, initiating a non-study cancer treatment, withdrawing
      consent, or becoming lost to follow-up. All subjects will be followed by telephone contact
      for overall survival until death, withdrawal of consent or the end of the study, whichever
      comes first.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Best overall response


Condition

Biliary Tract Cancer

Intervention

MK3475

Study Arms / Comparison Groups

 mk3475 200mg
Description:  Pembrolizumab (MK-3475) 200 mg every 3 weeks (Q3W) Open-label

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

33

Start Date

February 7, 2018

Completion Date

August 2021

Primary Completion Date

August 2020

Eligibility Criteria

        Inclusion Criteria:

          1. Have histologically or cytologically-confirmed diagnosis of biliary tract cancer
             including intra- and extra-hepatic biliary tract cancer

          2. Have metastatic disease or locally advanced, unresectable disease with feasible biopsy
             sites (baseline and follow up)

          3. Has experienced documented objective radiographic or clinical disease progression
             during or after first-line therapy containing any platinum/gemcitabine or any
             platinum/ fluoropyrimidine doublet.

          4. Have measurable disease based on RECIST as determined by investigator. Tumor lesions
             situated in a previously irradiated area are considered measurable if progression has
             been demonstrated in such lesions.

          5. Be willing to provide fresh tissue for biomarker analysis, and, based on the adequacy
             of the tissue sample quality for assessment of biomarker status. Repeat samples may be
             required if adequate tissue is not provided. Newly obtained endoscopic biopsy
             specimens are preferred to archived samples and formalin-fixed, paraffin-embedded
             (FFPE) block specimens are preferred to slides.

        Exclusion Criteria:

          1. Is currently participating and receiving study therapy or has participated in a study
             of an investigational agent and received study therapy or used an investigational
             device within 4 weeks of the first dose of treatment.

          2. Has squamous cell or sarcomatoid biliary duct cancer. Ampulla of Vater cancer. Gall
             bladder cancer

          3. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any
             other form of immunosuppressive therapy within 7 days prior to the first dose of trial
             treatment.

          4. Has a known history of active TB (Bacillus Tuberculosis)

          5. Hypersensitivity to pembrolizumab or any of its excipients.
      

Gender

All

Ages

20 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 82-2-3410-6820, [email protected]

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT03110328

Organization ID

2016-12-145


Responsible Party

Principal Investigator

Study Sponsor

Samsung Medical Center


Study Sponsor

, , 


Verification Date

December 2019