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

NCT03110328 | Completed Phase 2

• 1 other identifier: 2016-12-145
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (3)

• Best overall response

  Integrative genomic analysis to identify association of response and OS) and primary resistance to pembrolizumab with key genomic markers for immunotherapy

  12months

• progression-free survival

  Integrative genomic analysis to identify association of response and OS) and primary resistance to pembrolizumab with key genomic markers for immunotherapy

  12months

• overall survival

  Integrative genomic analysis to identify association of response and OS) and primary resistance to pembrolizumab with key genomic markers for immunotherapy

  12months

Study Arms (1)

mk3475 200mg

EXPERIMENTAL

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

Drug: MK3475

Interventions

MK3475 DRUG

anti-PD1 immunotherapy

Also known as: Pembrolizumab

mk3475 200mg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have histologically or cytologically-confirmed diagnosis of biliary tract cancer including intra- and extra-hepatic biliary tract cancer
• Have metastatic disease or locally advanced, unresectable disease with feasible biopsy sites (baseline and follow up)
• Has experienced documented objective radiographic or clinical disease progression during or after first-line therapy containing any platinum/gemcitabine or any platinum/ fluoropyrimidine doublet.
• 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.
• 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.

You may not qualify if:

• 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.
• Has squamous cell or sarcomatoid biliary duct cancer. Ampulla of Vater cancer. Gall bladder cancer
• 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.
• Has a known history of active TB (Bacillus Tuberculosis)
• Hypersensitivity to pembrolizumab or any of its excipients.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Pembrolizumab (MK-3475) 200 mg every 3 weeks (Q3W)

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: April 12, 2017
• Study Start: February 7, 2018
• Primary Completion: December 30, 2021
• Study Completion: March 24, 2022
• Last Updated: June 15, 2022

Record last verified: 2022-06

Locations

KR (1)