Biliary Tract CancerPhase 2NCT03110328
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
A Phase 2 study testing MK3475 in people with Biliary Tract Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- MK3475
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Feb 2018to 24 Mar 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Biliary Tract Cancer
- Being tested
- MK3475
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK3475Drug
Also called Pembrolizumab
anti-PD1 immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| mk3475 200mg | Experimental | Pembrolizumab (MK-3475) 200 mg every 3 weeks (Q3W) Open-label Receives: Drug: MK3475 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best overall response
Integrative genomic analysis to identify association of response and OS) and primary resistance to pembrolizumab with key genomic markers for immunotherapy
Measured: 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
Measured: 12months
overall survival
Integrative genomic analysis to identify association of response and OS) and primary resistance to pembrolizumab with key genomic markers for immunotherapy
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start7 Feb 2018
- Primary completion30 Dec 2021
- Study completion24 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pembrolizumab (MK-3475) 200 mg every 3 weeks (Q3W)
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung tae Kim,PhMD, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110328
- Sponsor's protocol ID
- 2016-12-145
- Status last verified
- Jun 2022
- First submitted
- 16 Mar 2017
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03110328
- Acronym / sponsor ID
- 2016-12-145
- Conditions
- Biliary Tract Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 24 Mar 2022 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pembrolizumab (MK-3475) 200 mg every 3 weeks (Q3W)
| Arm | Type | Receives |
|---|---|---|
| mk3475 200mg | Experimental | Drug: MK3475Pembrolizumab (MK-3475) 200 mg every 3 weeks (Q3W) Open-label |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK3475Also: Pembrolizumabanti-PD1 immunotherapy | Drug | mk3475 200mg |
Primary outcome
Best overall response
Time frame: 12months
Integrative genomic analysis to identify association of response and OS) and primary resistance to pembrolizumab with key genomic markers for immunotherapy
progression-free survival
Time frame: 12months
Integrative genomic analysis to identify association of response and OS) and primary resistance to pembrolizumab with key genomic markers for immunotherapy
overall survival
Time frame: 12months
Integrative genomic analysis to identify association of response and OS) and primary resistance to pembrolizumab with key genomic markers for immunotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
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Not yet recruitingPhase 3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MK3475 in people with Biliary Tract Cancer, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best overall response (time frame: 12months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.