Trial Outcomes & Findings for Phase II Trial of Pembrolizumab With Trastuzumab and Chemotherapy in Advanced HER2 Positive Esophagogastric (EG) Cancer (NCT NCT02954536)
NCT ID: NCT02954536
Last Updated: 2023-03-16
Results Overview
We will define progression of disease per RECIST 1.1 criteria
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
6 months
Results posted on
2023-03-16
Participant Flow
Participant milestones
| Measure |
Pembrolizumab, Trastuzumab,Capecitabine/Cisplatin
Pembrolizumab 200 mg IV every 3 weeks, trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) IV every 3 weeks with cisplatin IV every 3 weeks with oral capecitabine 2 weeks on/1 week off. Each cycle consists of 21 days. Treatment will be administered on an outpatient basis. In Cycle 1, patients will initiate therapy with trastuzumab 8 mg/kg IV with pembrolizumab 200 mg IV. CT/MRI scan will be performed after the initial 3 weeks (1 cycle) to determine response to pembrolizumab and trastuzumab combination. With subsequent cycles, all patients will begin systemic chemotherapy with the capecitabine/cisplatin regimen in addition to pembrolizumab 200 mg IV with trastuzumab 6 mg/kg maintenance. Patients will receive cisplatin 80 mg/m2 IV on Day 1, and capecitabine 850mg/m2 twice a day on Days 1 through 14, every 3 weeks.
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Pembrolizumab, Trastuzumab,Capecitabine/Cisplatin
Pembrolizumab 200 mg IV every 3 weeks, trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) IV every 3 weeks with cisplatin IV every 3 weeks with oral capecitabine 2 weeks on/1 week off. Each cycle consists of 21 days. Treatment will be administered on an outpatient basis. In Cycle 1, patients will initiate therapy with trastuzumab 8 mg/kg IV with pembrolizumab 200 mg IV. CT/MRI scan will be performed after the initial 3 weeks (1 cycle) to determine response to pembrolizumab and trastuzumab combination. With subsequent cycles, all patients will begin systemic chemotherapy with the capecitabine/cisplatin regimen in addition to pembrolizumab 200 mg IV with trastuzumab 6 mg/kg maintenance. Patients will receive cisplatin 80 mg/m2 IV on Day 1, and capecitabine 850mg/m2 twice a day on Days 1 through 14, every 3 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
12
|
Baseline Characteristics
Phase II Trial of Pembrolizumab With Trastuzumab and Chemotherapy in Advanced HER2 Positive Esophagogastric (EG) Cancer
Baseline characteristics by cohort
| Measure |
Pembrolizumab, Trastuzumab,Capecitabine/Cisplatin
n=37 Participants
Pembrolizumab 200 mg IV every 3 weeks, trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) IV every 3 weeks with cisplatin IV every 3 weeks with oral capecitabine 2 weeks on/1 week off. Each cycle consists of 21 days. Treatment will be administered on an outpatient basis. In Cycle 1, patients will initiate therapy with trastuzumab 8 mg/kg IV with pembrolizumab 200 mg IV. CT/MRI scan will be performed after the initial 3 weeks (1 cycle) to determine response to pembrolizumab and trastuzumab combination. With subsequent cycles, all patients will begin systemic chemotherapy with the capecitabine/cisplatin regimen in addition to pembrolizumab 200 mg IV with trastuzumab 6 mg/kg maintenance. Patients will receive cisplatin 80 mg/m2 IV on Day 1, and capecitabine 850mg/m2 twice a day on Days 1 through 14, every 3 weeks.
|
|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsWe will define progression of disease per RECIST 1.1 criteria
Outcome measures
| Measure |
Pembrolizumab, Trastuzumab,Capecitabine/Cisplatin
n=37 Participants
Pembrolizumab 200 mg IV every 3 weeks, trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) IV every 3 weeks with cisplatin IV every 3 weeks with oral capecitabine 2 weeks on/1 week off. Each cycle consists of 21 days. Treatment will be administered on an outpatient basis. In Cycle 1, patients will initiate therapy with trastuzumab 8 mg/kg IV with pembrolizumab 200 mg IV. CT/MRI scan will be performed after the initial 3 weeks (1 cycle) to determine response to pembrolizumab and trastuzumab combination. With subsequent cycles, all patients will begin systemic chemotherapy with the capecitabine/cisplatin regimen in addition to pembrolizumab 200 mg IV with trastuzumab 6 mg/kg maintenance. Patients will receive cisplatin 80 mg/m2 IV on Day 1, and capecitabine 850mg/m2 twice a day on Days 1 through 14, every 3 weeks.
|
|---|---|
|
Percentage of Participants With Progression Free Survival
|
70 percentage of participants with PRS
Interval 54.0 to 83.0
|
Adverse Events
Pembrolizumab, Trastuzumab,Capecitabine/Cisplatin
Serious events: 2 serious events
Other events: 36 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Pembrolizumab, Trastuzumab,Capecitabine/Cisplatin
n=37 participants at risk
Pembrolizumab 200 mg IV every 3 weeks, trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) IV every 3 weeks with cisplatin IV every 3 weeks with oral capecitabine 2 weeks on/1 week off. Each cycle consists of 21 days. Treatment will be administered on an outpatient basis. In Cycle 1, patients will initiate therapy with trastuzumab 8 mg/kg IV with pembrolizumab 200 mg IV. CT/MRI scan will be performed after the initial 3 weeks (1 cycle) to determine response to pembrolizumab and trastuzumab combination. With subsequent cycles, all patients will begin systemic chemotherapy with the capecitabine/cisplatin regimen in addition to pembrolizumab 200 mg IV with trastuzumab 6 mg/kg maintenance. Patients will receive cisplatin 80 mg/m2 IV on Day 1, and capecitabine 850mg/m2 twice a day on Days 1 through 14, every 3 weeks.
|
|---|---|
|
Renal and urinary disorders
Nephritis
|
5.4%
2/37 • 1 year
|
Other adverse events
| Measure |
Pembrolizumab, Trastuzumab,Capecitabine/Cisplatin
n=37 participants at risk
Pembrolizumab 200 mg IV every 3 weeks, trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) IV every 3 weeks with cisplatin IV every 3 weeks with oral capecitabine 2 weeks on/1 week off. Each cycle consists of 21 days. Treatment will be administered on an outpatient basis. In Cycle 1, patients will initiate therapy with trastuzumab 8 mg/kg IV with pembrolizumab 200 mg IV. CT/MRI scan will be performed after the initial 3 weeks (1 cycle) to determine response to pembrolizumab and trastuzumab combination. With subsequent cycles, all patients will begin systemic chemotherapy with the capecitabine/cisplatin regimen in addition to pembrolizumab 200 mg IV with trastuzumab 6 mg/kg maintenance. Patients will receive cisplatin 80 mg/m2 IV on Day 1, and capecitabine 850mg/m2 twice a day on Days 1 through 14, every 3 weeks.
|
|---|---|
|
Nervous system disorders
Parasthesis
|
97.3%
36/37 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
89.2%
33/37 • 1 year
|
|
General disorders
Fatigue
|
89.2%
33/37 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
83.8%
31/37 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
81.1%
30/37 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
73.0%
27/37 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
67.6%
25/37 • 1 year
|
|
Investigations
Increased ALT or AST
|
59.5%
22/37 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalaemia, hypomagnesaemia, or hyponatraemia
|
75.7%
28/37 • 1 year
|
|
Investigations
Decreased platelet count
|
59.5%
22/37 • 1 year
|
|
Investigations
Decreased lymphocyte count
|
59.5%
22/37 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
48.6%
18/37 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
43.2%
16/37 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
45.9%
17/37 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
43.2%
16/37 • 1 year
|
|
Investigations
Decreased while blood cell count
|
43.2%
16/37 • 1 year
|
|
Gastrointestinal disorders
Oral Mucositis
|
32.4%
12/37 • 1 year
|
|
Investigations
Weight loss
|
37.8%
14/37 • 1 year
|
|
Vascular disorders
Limb edema
|
27.0%
10/37 • 1 year
|
|
Nervous system disorders
Headache
|
27.0%
10/37 • 1 year
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
21.6%
8/37 • 1 year
|
|
Investigations
Increased blood bilirubin
|
21.6%
8/37 • 1 year
|
|
Investigations
Decreased neutrophil
|
18.9%
7/37 • 1 year
|
|
Cardiac disorders
Decreased ejection fraction
|
10.8%
4/37 • 1 year
|
|
Gastrointestinal disorders
Colitis
|
2.7%
1/37 • 1 year
|
Additional Information
Dr. Yelena Janjigian,MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4186
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place