Combination Margetuximab and Pembrolizumab for Advanced, Metastatic HER2(+) Gastric or Gastroesophageal Junction Cancer

• ClinicalTrials.gov Identifier: NCT02689284
• Recruitment Status: Completed
• First Posted: February 23, 2016
• Results First Posted: August 4, 2022
• Last Update Posted: August 4, 2022
• Sponsor: MacroGenics
• Collaborator: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): MacroGenics

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Gastric Cancer; Stomach Cancer; Esophageal Cancer
• Interventions: Biological: Margetuximab 10 mg/kg; Biological: Margetuximab 15 mg; Biological: Pembrolizumab
• Enrollment: 95

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Arm/Group Description	combination treatment is administered once every 21-day cycle	combination treatment is administered once every 21-day cycle
Period Title: Overall Study
Started	3	92
Completed	0	5
Not Completed	3	87
Reason Not Completed
Adverse Event	1	8
Death	0	1
Physician Decision	1	2
Withdrawal by Subject	0	1
progression of cancer	1	72
decreased heart function	0	1
concern for anemia	0	1
no measurable cancer for evaluation	0	1

Baseline Characteristics

Arm/Group Title		Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)	Total
Arm/Group Description		combination treatment is administered once every 21-day cycle	combination treatment is administered once every 21-day cycle	Total of all reporting groups
Overall Number of Baseline Participants		3	92	95
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	3 participants	92 participants	95 participants
		62.7 (9.87)	60.2 (12.83)	60.3 (12.71)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	3 participants	92 participants	95 participants
	Female	0 0.0%	17 18.5%	17 17.9%
	Male	3 100.0%	75 81.5%	78 82.1%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	3 participants	92 participants	95 participants
	Hispanic or Latino	0 0.0%	2 2.2%	2 2.1%
	Not Hispanic or Latino	3 100.0%	88 95.7%	91 95.8%
	Unknown or Not Reported	0 0.0%	2 2.2%	2 2.1%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	3 participants	92 participants	95 participants
	American Indian or Alaska Native	0 0.0%	1 1.1%	1 1.1%
	Asian	0 0.0%	51 55.4%	51 53.7%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	3 3.3%	3 3.2%
	White	3 100.0%	34 37.0%	37 38.9%
	More than one race	0 0.0%	1 1.1%	1 1.1%
	Unknown or Not Reported	0 0.0%	2 2.2%	2 2.1%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants	Number Analyzed	3 participants	92 participants	95 participants
Canada		0	3	3
South Korea		0	42	42
Singapore		0	8	8
United States		3	38	41
Taiwan		0	1	1
ECOG Performance Status [1]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	3 participants	92 participants	95 participants
0		0	33	33
1		3	59	62
		[1] Measure Description: Eastern Cooperative Oncology Group (ECOG) performance status is a 0-5 measurement of the participant's limitations on everyday activities due to cancer. A score of 0 indicates fully active; no performance restrictions. A score of 1 indicates strenuous physical activity restricted; fully ambulatory and able to carry out light work.
Primary tumor location; Measure Type: Number; Unit of measure: Participants	Number Analyzed	3 participants	92 participants	95 participants
Gastric		0	61	61
Gastroesophageal junction		3	31	34
HER2 status using immunohistochemistry (IHC) [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	3 participants	92 participants	95 participants
	IHC 2+	2 66.7%	21 22.8%	23 24.2%
	IHC 3+	1 33.3%	71 77.2%	72 75.8%
		[1] Measure Description: HER2 is a growth factor present in some gastric cancers HER2 stats is a measure of how much HER2 is present in the cancer tissue and how sensitive the cancer may be to HER2 blockage. Participants with cancer that is IHC 3+ are most sensitive to treatment with a HER2 inhibitor like margetuximab.
PD-L1 Status [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	3 participants	92 participants	95 participants
	PD-L1 positive	1 33.3%	33 35.9%	34 35.8%
	PD-L1 negative	1 33.3%	43 46.7%	44 46.3%
	unknown	1 33.3%	16 17.4%	17 17.9%
		[1] Measure Description: PD-L1 is present in some gastric cancers. Participants with cancer that is PD-L1+ are most sensitive to treatment with immunotherapy like pembrolizumab.
HER2 IHC 3+ and PD-L1 positive; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	3 participants	92 participants	95 participants
		0 0.0%	25 27.2%	25 26.3%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Dose Limiting Toxicities
Description	Characterize maximum tolerated dose (MTD) or maximum administered dose (MAD) (if no MTD is defined) of margetuximab when administered in combination with pembrolizumab
Time Frame	21 days

Outcome Measure Data

Analysis Population Description

Dose escalation cohorts to determine the expansion cohort dose.

Arm/Group Title	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Arm/Group Description:	combination treatment is administered once every 21-day cycle	combination treatment is administered once every 21-day cycle
Overall Number of Participants Analyzed	3	6
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%

2. Primary Outcome

Title	Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs).
Description	The number of patients that experience either an AE or a SAE during the study participation
Time Frame	up to 24 months

Outcome Measure Data

Analysis Population Description

All patients receiving at least 1 dose of margetuximab or pembrolizumab

Arm/Group Title	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Arm/Group Description:	combination treatment is administered once every 21-day cycle	combination treatment is administered once every 21-day cycle
Overall Number of Participants Analyzed	3	92
Measure Type: Count of Participants; Unit of Measure: Participants
	3 100.0%	86 93.5%

3. Primary Outcome

Title	Number of Patients With a Complete Response (CR) or Partial Response (PR) to Treatment
Description	Investigate the preliminary anti-tumor activity as measured by response to treatment of margetuximab when administered in combination with pembrolizumab, using conventional Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Arm/Group Description:	combination treatment is administered once every 21-day cycle	combination treatment is administered once every 21-day cycle
Overall Number of Participants Analyzed	3	92
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	18 19.6%

4. Primary Outcome

Title	Number of Patients With a Complete Response (CR) or Partial Response (PR) to Treatment Using irRC Criteria
Description	Investigate the preliminary anti-tumor activity, as measured by objective response rate (ORR) of margetuximab when administered in combination with pembrolizumab, using immune-related response criteria (irRC).
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

Analysis is limited to patients receiving margetuximab (15 mg/kg) and pembrolizumab (200 mg)

Arm/Group Title	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Arm/Group Description:	combination treatment is administered once every 21-day cycle	combination treatment is administered once every 21-day cycle
Overall Number of Participants Analyzed	3	92
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	19 20.7%

5. Primary Outcome

Title	Duration of Response
Description	Duration of response is calculated at the time from CR or PR to relapse or cancer progression.
Time Frame	up to 24 months

Outcome Measure Data

Analysis Population Description

There were no responders in the 10mg/kg group

Arm/Group Title	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Arm/Group Description:	combination treatment is administered once every 21-day cycle	combination treatment is administered once every 21-day cycle
Overall Number of Participants Analyzed	0	92
Median (95% Confidence Interval); Unit of Measure: months
		12.1; (2.79 to 26.68)

6. Secondary Outcome

Title	Overall Survival (OS)
Description	The median length of time between first dose of study medication and death from any cause.
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Arm/Group Description:	combination treatment is administered once every 21-day cycle	combination treatment is administered once every 21-day cycle
Overall Number of Participants Analyzed	3	92
Median (95% Confidence Interval); Unit of Measure: months
	7.0; (2.37 to 9.66)	12.7; (9.07 to 14.62)

7. Secondary Outcome

Title	Progression Free Survival (PFS)
Description	The interval between the first dose of study medication and progression of disease or death from any cause.
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Arm/Group Description:	combination treatment is administered once every 21-day cycle	combination treatment is administered once every 21-day cycle
Overall Number of Participants Analyzed	3	92
Median (95% Confidence Interval); Unit of Measure: months
	1.4; (1.31 to 2.76)	2.7; (0.37 to 4.34)

8. Secondary Outcome

Title	Change From Baseline in Pharmacodynamic Markers in Whole Blood
Description	The planned assessment included examination of markers of T-cell activation
Time Frame	from first dose to the end of treatment, average about 12 months

Outcome Measure Data

Analysis Population Description

Analysis was not performed. A number of samples were degraded in shipping rendering insufficient samples to conduct the analysis.

Arm/Group Title	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Arm/Group Description:	combination treatment is administered once every 21-day cycle	combination treatment is administered once every 21-day cycle
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

9. Secondary Outcome

Title	Analysis of HER2 Tumor Cell Membrane Expression in Biopsy Specimens Before and After Treatment
Description	[Not Specified]
Time Frame	from first dose to the end of treatment, average 12 months.

Outcome Measure Data

Analysis Population Description

Sample collection was planned for the Margetuximab (15 mg/kg) plus pembrolizumab (200 mg) cohort only. No samples were received that could be tested. The analysis could not be conducted.

Arm/Group Title	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Arm/Group Description:	combination treatment is administered once every 21-day cycle
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

10. Secondary Outcome

Title	Number of Patients Who Develop Treatment-emergent Anti-drug Antibodies to Margetuximab (Immunogenicity)
Description	[Not Specified]
Time Frame	Assessed Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Day 1 of every odd cycle, and end of treatment visit, average 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Arm/Group Description:	combination treatment is administered once every 21-day cycle	combination treatment is administered once every 21-day cycle
Overall Number of Participants Analyzed	3	92
Measure Type: Count of Participants; Unit of Measure: Participants
	1 33.3%	4 4.3%

11. Secondary Outcome

Title	Maximum Concentration of Margetuximab at Steady State
Description	Measurement of PK characteristics is limited to margetuximab. No analysis of pembrolizumab was conducted.
Time Frame	At end of infusion on Cycle 1, Day 1. Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit, average 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Arm/Group Description:	combination treatment is administered once every 21-day cycle	combination treatment is administered once every 21-day cycle
Overall Number of Participants Analyzed	3	92
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: mcg/mL
	197; (0.249%)	318; (0.168%)

12. Secondary Outcome

Title	Area Under the Concentration Time Curve at Steady State (AUC ss)
Description	AUC is a mathematical calculation that describes the variation in drug concentration in the blood over time.
Time Frame	Predose and at end of infusion on Cycle 1, Days 1, 2 and 8: Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit, average 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Arm/Group Description:	combination treatment is administered once every 21-day cycle	combination treatment is administered once every 21-day cycle
Overall Number of Participants Analyzed	3	92
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: mcg/mL* day
	1710; (0.358%)	2720; (0.329%)

13. Secondary Outcome

Title	Clearance
Description	Drug clearance is the amount of drug removed from the bloodstream by the body per unit of time.
Time Frame	Predose and at end of infusion on Cycle 1, Days 1, 2 and 8: Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit, average 12 months.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Arm/Group Description:	combination treatment is administered once every 21-day cycle	combination treatment is administered once every 21-day cycle
Overall Number of Participants Analyzed	3	92
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: liters per day
	0.381; (0.0394%)	0.329; (0.296%)

14. Secondary Outcome

Title	Volume of Distribution at Steady State
Description	The volume of distribution is related to a whether how much drug is distributed to body tissues, or remains in the bloodstream.
Time Frame	Predose and at end of infusion on Cycle 1, Days 1, 2 and 8: Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit average 12 months .

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Arm/Group Description:	combination treatment is administered once every 21-day cycle	combination treatment is administered once every 21-day cycle
Overall Number of Participants Analyzed	3	92
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: liters
	7.7; (0.306%)	6.37; (0.205%)

15. Secondary Outcome

Title	Terminal Half-life
Description	Terminal half-life is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium.
Time Frame	Predose and at end of infusion on Cycle 1, Days 1, 2 and 8: Cycle 2, Day 1; Cycle 3, Days 1 and 2; Cycle 5 Day 1, Cycle 7 Day 1, and end of treatment visit average 12 months .

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Arm/Group Description:	combination treatment is administered once every 21-day cycle	combination treatment is administered once every 21-day cycle
Overall Number of Participants Analyzed	3	92
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: day
	17.2; (0.312%)	16.2; (0.286%)

Adverse Events

Time Frame	All AEs and SAEs were collected from the time of first dose through 28 days after the last dose or until the start of another anti-cancer treatment, whichever was earlier, average 12 months.
Adverse Event Reporting Description	Adverse event reporting is based on physical examination findings, patient reports, and clinically significant abnormal laboratory values. Progression of the underlying neoplasm resulting in hospitalization or death was documented as an antitumor activity outcome and not as an SAE, unless considered drug-related by the investigator. If an SAE occured in a patient and it was unclear whether the event was related to progressive disease, the SAE was reported.
Arm/Group Title	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Arm/Group Description	combination treatment is administered once every 21-day cycle	combination treatment is administered once every 21-day cycle
All-Cause Mortality
	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	3/3 (100.00%)	69/92 (75.00%)
Serious Adverse Events
	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	2/3 (66.67%)	38/92 (41.30%)
Blood and lymphatic system disorders
Anaemia † 1	0/3 (0.00%)	9/92 (9.78%)
Endocrine disorders
Hypophysitis † 1	0/3 (0.00%)	1/92 (1.09%)
Gastrointestinal disorders
Obstruction gastric † 1	0/3 (0.00%)	4/92 (4.35%)
Gastric haemorrhage † 1	0/3 (0.00%)	2/92 (2.17%)
Oesophageal haemorrhage † 1	0/3 (0.00%)	2/92 (2.17%)
Small intestinal obstruction † 1	0/3 (0.00%)	2/92 (2.17%)
Upper gastrointestinal haemorrhage † 1	0/3 (0.00%)	2/92 (2.17%)
Abdominal pain † 1	0/3 (0.00%)	1/92 (1.09%)
Ascites † 1	0/3 (0.00%)	1/92 (1.09%)
Diarrhoea † 1	0/3 (0.00%)	1/92 (1.09%)
Dysphagia † 1	0/3 (0.00%)	1/92 (1.09%)
Gastrointestinal haemorrhage † 1	0/3 (0.00%)	1/92 (1.09%)
Gastrointestinal obstruction † 1	0/3 (0.00%)	1/92 (1.09%)
Ileus † 1	0/3 (0.00%)	1/92 (1.09%)
Vomiting † 1	0/3 (0.00%)	1/92 (1.09%)
General disorders
Pyrexia † 1	0/3 (0.00%)	2/92 (2.17%)
Asthenia † 1	0/3 (0.00%)	1/92 (1.09%)
Fatigue † 1	0/3 (0.00%)	1/92 (1.09%)
Hepatobiliary disorders
Autoimmune hepatitis † 1	0/3 (0.00%)	2/92 (2.17%)
Biliary obstruction † 1	0/3 (0.00%)	1/92 (1.09%)
Infections and infestations
Cellulitis † 1	0/3 (0.00%)	2/92 (2.17%)
Pneumonia † 1	0/3 (0.00%)	2/92 (2.17%)
Eye infection † 1	0/3 (0.00%)	1/92 (1.09%)
Infective exacerbation of chronic obstructive airways disease † 1	1/3 (33.33%)	0/92 (0.00%)
Influenza † 1	0/3 (0.00%)	1/92 (1.09%)
Liver abscess † 1	0/3 (0.00%)	1/92 (1.09%)
Osteomyelitis † 1	0/3 (0.00%)	1/92 (1.09%)
Peritonitis † 1	0/3 (0.00%)	1/92 (1.09%)
Renal abscess † 1	0/3 (0.00%)	1/92 (1.09%)
Injury, poisoning and procedural complications
Infusion related reaction † 1	0/3 (0.00%)	1/92 (1.09%)
Metabolism and nutrition disorders
Decreased appetite † 1	0/3 (0.00%)	1/92 (1.09%)
Dehydration † 1	0/3 (0.00%)	1/92 (1.09%)
Diabetic ketoacidosis † 1	0/3 (0.00%)	1/92 (1.09%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	0/3 (0.00%)	1/92 (1.09%)
Back pain † 1	0/3 (0.00%)	1/92 (1.09%)
Muscular weakness † 1	0/3 (0.00%)	1/92 (1.09%)
Pain in extremity † 1	1/3 (33.33%)	0/92 (0.00%)
Nervous system disorders
Headache † 1	0/3 (0.00%)	1/92 (1.09%)
Seizure † 1	0/3 (0.00%)	1/92 (1.09%)
Syncope † 1	0/3 (0.00%)	1/92 (1.09%)
Product Issues
Device dislocation † 1	0/3 (0.00%)	1/92 (1.09%)
Psychiatric disorders
Confusional state † 1	0/3 (0.00%)	1/92 (1.09%)
Reproductive system and breast disorders
Adnexal torsion † 1	0/3 (0.00%)	1/92 (1.09%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure † 1	1/3 (33.33%)	0/92 (0.00%)
Dyspnoea † 1	0/3 (0.00%)	1/92 (1.09%)
Pneumomediastinum † 1	0/3 (0.00%)	1/92 (1.09%)
Pneumonia aspiration † 1	0/3 (0.00%)	1/92 (1.09%)
Pneumonitis † 1	0/3 (0.00%)	1/92 (1.09%)
Vascular disorders
Hypotension † 1	0/3 (0.00%)	2/92 (2.17%)
1 Term from vocabulary, MedDRA 24.0; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)	Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	3/3 (100.00%)	86/92 (93.48%)
Blood and lymphatic system disorders
Anaemia † 1	0/3 (0.00%)	29/92 (31.52%)
Gastrointestinal disorders
Diarrhoea † 1	1/3 (33.33%)	26/92 (28.26%)
Nausea † 1	0/3 (0.00%)	23/92 (25.00%)
Abdominal pain † 1	0/3 (0.00%)	16/92 (17.39%)
Vomiting † 1	0/3 (0.00%)	16/92 (17.39%)
Dyspepsia † 1	0/3 (0.00%)	12/92 (13.04%)
Constipation † 1	1/3 (33.33%)	10/92 (10.87%)
Dysphagia † 1	0/3 (0.00%)	8/92 (8.70%)
Abdominal distension † 1	0/3 (0.00%)	7/92 (7.61%)
Gastrooesophageal reflux disease † 1	0/3 (0.00%)	6/92 (6.52%)
General disorders
Fatigue † 1	1/3 (33.33%)	25/92 (27.17%)
Oedema peripheral † 1	0/3 (0.00%)	10/92 (10.87%)
Pyrexia † 1	0/3 (0.00%)	8/92 (8.70%)
Infections and infestations
Upper respiratory tract infection † 1	0/3 (0.00%)	6/92 (6.52%)
Injury, poisoning and procedural complications
Infusion related reaction † 1	1/3 (33.33%)	12/92 (13.04%)
Investigations
Weight decreased † 1	0/3 (0.00%)	11/92 (11.96%)
Amylase increased † 1	0/3 (0.00%)	7/92 (7.61%)
Aspartate aminotransferase increased † 1	0/3 (0.00%)	6/92 (6.52%)
Lipase increased † 1	0/3 (0.00%)	6/92 (6.52%)
Alanine aminotransferase increased † 1	0/3 (0.00%)	5/92 (5.43%)
Blood creatinine increased † 1	0/3 (0.00%)	5/92 (5.43%)
Metabolism and nutrition disorders
Decreased appetite † 1	1/3 (33.33%)	16/92 (17.39%)
Hypoalbuminaemia † 1	0/3 (0.00%)	12/92 (13.04%)
Hyponatraemia † 1	0/3 (0.00%)	6/92 (6.52%)
Musculoskeletal and connective tissue disorders
Back pain † 1	1/3 (33.33%)	12/92 (13.04%)
Arthralgia † 1	1/3 (33.33%)	5/92 (5.43%)
Myalgia † 1	0/3 (0.00%)	5/92 (5.43%)
Nervous system disorders
Dizziness † 1	0/3 (0.00%)	5/92 (5.43%)
Neuropathy peripheral † 1	0/3 (0.00%)	5/92 (5.43%)
Psychiatric disorders
Insomnia † 1	0/3 (0.00%)	12/92 (13.04%)
Respiratory, thoracic and mediastinal disorders
Cough † 1	0/3 (0.00%)	13/92 (14.13%)
Dyspnoea † 1	0/3 (0.00%)	6/92 (6.52%)
Skin and subcutaneous tissue disorders
Pruritus † 1	0/3 (0.00%)	18/92 (19.57%)
Rash † 1	0/3 (0.00%)	9/92 (9.78%)
Rash maculo-papular † 1	0/3 (0.00%)	8/92 (8.70%)
1 Term from vocabulary, MedDRA 24.0; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Chief Medical Officer
• Organization: MacroGenics, Inc.
• Phone: 301.251.5172
• EMail: info@macrogenics.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Catenacci DVT, Kang YK, Park H, Uronis HE, Lee KW, Ng MCH, Enzinger PC, Park SH, Gold PJ, Lacy J, Hochster HS, Oh SC, Kim YH, Marrone KA, Kelly RJ, Juergens RA, Kim JG, Bendell JC, Alcindor T, Sym SJ, Song EK, Chee CE, Chao Y, Kim S, Lockhart AC, Knutson KL, Yen J, Franovic A, Nordstrom JL, Li D, Wigginton J, Davidson-Moncada JK, Rosales MK, Bang YJ; CP-MGAH22-5 Study Group. Margetuximab plus pembrolizumab in patients with previously treated, HER2-positive gastro-oesophageal adenocarcinoma (CP-MGAH22-05): a single-arm, phase 1b-2 trial. Lancet Oncol. 2020 Aug;21(8):1066-1076. doi: 10.1016/S1470-2045(20)30326-0. Epub 2020 Jul 9.

• Responsible Party: MacroGenics
• ClinicalTrials.gov Identifier: NCT02689284
• Other Study ID Numbers: CP-MGAH22-05
• First Submitted: January 27, 2016
• First Posted: February 23, 2016
• Results First Submitted: February 28, 2022
• Results First Posted: August 4, 2022
• Last Update Posted: August 4, 2022