Trial Outcomes & Findings for 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 (NCT NCT02589496)

Last Updated: 2023-05-09

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

80 participants

Primary outcome timeframe

up to 2 years

Results posted on

2023-05-09

Participant Flow

Participant milestones

Participant milestones
Measure	Pembrolizumab Cohort A :gastric cancer patients Cohort B : MSI-H gastric cancer patients All Chort receive the following treatment. * Pembrolizumab 200 mg every 3 weeks pembrolizumab: 200 mg every 3 weeks
Overall Study STARTED	80
Overall Study COMPLETED	80
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab n=61 Participants Cohort A :gastric cancer patients Cohort B : MSI-H gastric cancer patients All Chort receive the following treatment. * Pembrolizumab 200 mg every 3 weeks pembrolizumab: 200 mg every 3 weeks
Age, Continuous	57 years n=93 Participants
Sex: Female, Male Female	18 Participants n=93 Participants
Sex: Female, Male Male	43 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	61 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	61 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment South Korea	61 participants n=93 Participants
gastric cancer	61 Participants n=93 Participants

PRIMARY outcome

Timeframe: up to 2 years

Outcome measures

Outcome measures
Measure	Pembrolizumab n=61 Participants Cohort A :gastric cancer patients Cohort B : MSI-H gastric cancer patients All Chort receive the following treatment. * Pembrolizumab 200 mg every 3 weeks pembrolizumab: 200 mg every 3 weeks
RR	15 Participants

PRIMARY outcome

Timeframe: 2 years

Population: metastatic gastric cancer patients who failed to standard cytototic chemotherapy

response rate per RECIST 1.1

Outcome measures

Outcome measures
Measure	Pembrolizumab n=61 Participants Cohort A :gastric cancer patients Cohort B : MSI-H gastric cancer patients All Chort receive the following treatment. * Pembrolizumab 200 mg every 3 weeks pembrolizumab: 200 mg every 3 weeks
Response Rate	15 Participants

Adverse Events

Pembrolizumab

Serious events: 0 serious events

Other events: 25 other events

Deaths: 25 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pembrolizumab n=61 participants at risk Cohort A :gastric cancer patients All Chort receive the following treatment. * Pembrolizumab 200 mg every 3 weeks pembrolizumab: 200 mg every 3 weeks
Skin and subcutaneous tissue disorders rash	3.3% 2/61 • Number of events 2 • 2 years
Skin and subcutaneous tissue disorders pruritis	11.5% 7/61 • Number of events 7 • 2 years
Gastrointestinal disorders nausea	6.6% 4/61 • Number of events 4 • 2 years
Gastrointestinal disorders diarrhea	3.3% 2/61 • Number of events 2 • 2 years
Nervous system disorders peripheral sensory neuropathy	8.2% 5/61 • Number of events 5 • 2 years
General disorders myalgia	1.6% 1/61 • Number of events 1 • 2 years
Hepatobiliary disorders elevated liver enzyme	3.3% 2/61 • Number of events 2 • 2 years
Musculoskeletal and connective tissue disorders arthritis	1.6% 1/61 • Number of events 1 • 2 years
Gastrointestinal disorders dry mouth	1.6% 1/61 • Number of events 1 • 2 years

Additional Information

Jeeyun Lee

Samsung Medical Center

Phone: 82234101779

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place