Trial Outcomes & Findings for Pembrolizumab Plus Ramucirumab in Metastatic Gastric Cancer (NCT NCT04632459)
NCT ID: NCT04632459
Last Updated: 2026-06-05
Results Overview
Modified RECIST 1.1 criteria will be used to assess patient response to treatment by determining PFS and ORR. The modified RECIST 1.1 guidelines for measurable, non-measurable, target and non-target lesions and the objective tumour response criteria
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
up to 24months
Results posted on
2026-06-05
Participant Flow
Samsung Medical Center
Participant milestones
| Measure |
Pembrolizumab Plus Ramucirumab
* Ramucirumab 8mg/kg on q2W
* Pembrolizumab 200mg on q3W (pembrolizumab first followed by ramucirumab when concurrently administered on the same day)
* If ramucirumab had to be stopped due to intolerable toxicity, pembrolizumab will be continued until unacceptable toxicity, disease progression or upto 35 cycles
pembrolizumab plus ramucirumab: Patients will continue to receive study treatment, until they demonstrate objective disease progression (determined by modified RECIST 1.1) or until they meet any other discontinuation criteria.
* Ramucirumab 8mg/kg on q2W
* Pembrolizumab 200mg on q3W (pembrolizumab first followed by ramucirumab when concurrently administered on the same day)
* If ramucirumab had to be stopped due to intolerable toxicity, pembrolizumab will be continued until unacceptable toxicity, disease progression or upto 35 cycles.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab Plus Ramucirumab in Metastatic Gastric Cancer
Baseline characteristics by cohort
| Measure |
Pembrolizumab Plus Ramucirumab
n=26 Participants
* Ramucirumab 8mg/kg on q2W
* Pembrolizumab 200mg on q3W (pembrolizumab first followed by ramucirumab when concurrently administered on the same day)
* If ramucirumab had to be stopped due to intolerable toxicity, pembrolizumab will be continued until unacceptable toxicity, disease progression or upto 35 cycles
pembrolizumab plus ramucirumab: Patients will continue to receive study treatment, until they demonstrate objective disease progression (determined by modified RECIST 1.1) or until they meet any other discontinuation criteria.
* Ramucirumab 8mg/kg on q2W
* Pembrolizumab 200mg on q3W (pembrolizumab first followed by ramucirumab when concurrently administered on the same day)
* If ramucirumab had to be stopped due to intolerable toxicity, pembrolizumab will be continued until unacceptable toxicity, disease progression or upto 35 cycles.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=20 Participants
|
|
Age, Continuous
|
63 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
26 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
South Korea
|
26 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: up to 24monthsModified RECIST 1.1 criteria will be used to assess patient response to treatment by determining PFS and ORR. The modified RECIST 1.1 guidelines for measurable, non-measurable, target and non-target lesions and the objective tumour response criteria
Outcome measures
| Measure |
Pembrolizumab Plus Ramucirumab
n=26 Participants
* Ramucirumab 8mg/kg on q2W
* Pembrolizumab 200mg on q3W (pembrolizumab first followed by ramucirumab when concurrently administered on the same day)
* If ramucirumab had to be stopped due to intolerable toxicity, pembrolizumab will be continued until unacceptable toxicity, disease progression or upto 35 cycles
pembrolizumab plus ramucirumab: Patients will continue to receive study treatment, until they demonstrate objective disease progression (determined by modified RECIST 1.1) or until they meet any other discontinuation criteria.
* Ramucirumab 8mg/kg on q2W
* Pembrolizumab 200mg on q3W (pembrolizumab first followed by ramucirumab when concurrently administered on the same day)
* If ramucirumab had to be stopped due to intolerable toxicity, pembrolizumab will be continued until unacceptable toxicity, disease progression or upto 35 cycles.
|
|---|---|
|
Objective Response Rate (ORR)
|
23.1 percentage of ORR
Interval 4.1 to 34.3
|
SECONDARY outcome
Timeframe: 24monthsOutcome measures
Outcome data not reported
Adverse Events
Pembrolizumab Plus Ramucirumab
Serious events: 1 serious events
Other events: 5 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Pembrolizumab Plus Ramucirumab
n=26 participants at risk
* Ramucirumab 8mg/kg on q2W through study completion or progression of disease or up to 35 cycles or stopped due to intolerable toxicity.
* Pembrolizumab 200mg on q3W through study completion or progression of disease (pembrolizumab first followed by ramucirumab when concurrently administered on the same day).
* If ramucirumab had to be stopped due to intolerable toxicity, pembrolizumab will be continued until unacceptable toxicity, disease progression or up to 35 cycles.
pembrolizumab plus ramucirumab: Patients will continue to receive study treatment, until they demonstrate objective disease progression (determined by modified RECIST 1.1) or until they meet any other discontinuation criteria.
* Ramucirumab 8mg/kg on q2W through study completion or progression of disease or up to 35 cycles or stopped due to intolerable toxicity.
* Pembrolizumab 200mg on q3W (pembrolizumab first followed by ramucirumab when concurrently administered on the same day) through study completion or progression of disease or up to 35 cycles or stopped due to intolerable toxicity.
* If ramucirumab had to be stopped due to intolerable toxicity, pembrolizumab will be continued until unacceptable toxicity, disease progression or upto 35 cycles.
|
|---|---|
|
Gastrointestinal disorders
Gastric Toxicity
|
3.8%
1/26 • Number of events 1 • throught the study, from enrollment untill end of follow-up (an average of 1year)
|
Other adverse events
| Measure |
Pembrolizumab Plus Ramucirumab
n=26 participants at risk
* Ramucirumab 8mg/kg on q2W through study completion or progression of disease or up to 35 cycles or stopped due to intolerable toxicity.
* Pembrolizumab 200mg on q3W through study completion or progression of disease (pembrolizumab first followed by ramucirumab when concurrently administered on the same day).
* If ramucirumab had to be stopped due to intolerable toxicity, pembrolizumab will be continued until unacceptable toxicity, disease progression or up to 35 cycles.
pembrolizumab plus ramucirumab: Patients will continue to receive study treatment, until they demonstrate objective disease progression (determined by modified RECIST 1.1) or until they meet any other discontinuation criteria.
* Ramucirumab 8mg/kg on q2W through study completion or progression of disease or up to 35 cycles or stopped due to intolerable toxicity.
* Pembrolizumab 200mg on q3W (pembrolizumab first followed by ramucirumab when concurrently administered on the same day) through study completion or progression of disease or up to 35 cycles or stopped due to intolerable toxicity.
* If ramucirumab had to be stopped due to intolerable toxicity, pembrolizumab will be continued until unacceptable toxicity, disease progression or upto 35 cycles.
|
|---|---|
|
General disorders
Fatigue
|
19.2%
5/26 • Number of events 5 • throught the study, from enrollment untill end of follow-up (an average of 1year)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place