Study of Pembrolizumab in Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-Line Therapy With Platinum and Fluoropyrimidine: Integration of Molecular Subtypes Through Integrative Genomic Analysis
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|ClinicalTrials.gov Identifier: NCT02589496|
Recruitment Status : Active, not recruiting
First Posted : October 28, 2015
Last Update Posted : December 14, 2020
This is a single-arm, single-center, open-label trial of pembrolizumab (MK-3475) in subjects with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have progressed after failure of any combination chemotherapy containing a platinum and a fluoropyrimidine agent.
Approximately 60 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).
In the expansion cohort (cohort B), it was expanded on the original cohort based on response analysis and will be opened separately.
Of the 5 MSI-high patients who were enrolled on to original cohort, all 5 MSI high GC patients (100% response rate) demonstrated dramatic response rate.
Based on this finding, in order to proven Pembrolizumab's efficacy to specific MSI-H GC population, we would like enroll 20 more patients in cohort B. Based on our screening protocol, the prevalence of MSI-high in GC is about 15 %. Only MSI-high GC patients will be included. All the eligibility will be the same.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma||Drug: pembrolizumab||Phase 2|
Each subject will participate in the trial from the time the subject signs the Informed Consent Form (ICF) through the final contact. After a screening phase of up to 28 days, eligible subjects will receive treatment beginning on Day 1 of each 3-week dosing cycle for pembrolizumab.
Treatment with pembrolizumab or paclitaxel will continue until documented disease progression, unacceptable adverse event(s), undercurrent illness that prevents further administration of treatment, Investigator's decision to withdraw the subject, subject withdraw consent, pregnancy of the subject, noncompliance with trial treatment o procedure requirements, subject receives 24 months of pembrolizumab, or administrative reasons requiring 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 within the pembrolizumab arm who discontinue after 24 months of therapy for reasons other than disease progression or intolerability or who discontinue after attaining a CR may be eligible for up to one year of retreatment after they have experienced radiographic disease progression.
Subjects who discontinue 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 for overall survival until death, withdrawal of consent, or the end of the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Pembrolizumab in Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-Line Therapy With Platinum and Fluoropyrimidine: Integration of Molecular Subtypes Through Integrative Genomic Analysis|
|Actual Study Start Date :||March 26, 2016|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Cohort A :gastric cancer patients Cohort B : MSI-H gastric cancer patients All Chort receive the following treatment.
200 mg every 3 weeks
- RR [ Time Frame: up to 2 years ]Objective: To evaluate RR per mRECIST in advanced gastric or GEJ adenocarcinoma who have progressed on one previous line of therapy, when treated with pembrolizumab Hypothesis: Pembrolizumab increases RR per mRECIST with advanced gastric or GEJ adenocarcinoma who have progressed on 1 previous line of therapy
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): NCT02589496
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Korea, Republic of, 135-720|