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CompletedNCT02689284Updated Mar 17, 2025Results posted

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

A Phase 1/2 interventional study of Margetuximab 10 mg/kg and Margetuximab 15 mg in Gastric Cancer, Stomach Cancer and Esophageal Cancer, sponsored by MacroGenics. Completed at 28 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-17.

Sponsored by MacroGenics · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
95
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This main purpose of this clinical study is to learn about the safety and activity of margetuximab and pembrolizumab combination treatment in patients with HER2+ gastric and gastroesophageal junction cancer.

Read the detailed description

Detailed Description: Both margetuximab and pembrolizumab are monoclonal antibodies used in combination to treat HER2+ gastric and gastroesophageal junction cancer. This study has two parts: Dose Escalation and Dose Expansion. The Dose Escalation phase of the study will evaluate safety of escalating doses of the combination treatment. The Dose Expansion phase will evaluate safety and activity of the combination in patients with gastric or gastroesophageal cancer once the final dose and schedule are defined. In addition, a cohort of patients with HER2+ 3+ gastric cancer patients will be enrolled in the Dose Expansion Phase.

02

Conditions studied

  • Gastric Cancer
  • Stomach Cancer
  • Esophageal Cancer

Browse trials for

03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's enrollment of 95 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

MacroGenics is the lead sponsor of 42 studies on the registry; 4 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 11 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Signed written informed consent.
  2. Age ≥ 18 years old (or minimum age based upon local regulations)
  3. Unresectable locally advanced or metastatic histologically proven HER2+ gastroesophageal junction (GEJ) or gastric cancer. Gastric Cancer Expansion Phase will include only gastric cancer patients with 3+ HER2 positivity.
  4. HER2+ as 3+ (as defined in AJCC staging manual 8th edition) by IHC or in-situ hybridation (ISH) amplified.
  5. Have received prior treatment with trastuzumab.
  6. Have received treatment with at least one or more lines of cytotoxic chemotherapy in the metastatic setting.
  7. Resolution of chemotherapy, immunotherapy or radiation-related toxicities.
  8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  9. Life expectancy ≥ 12 weeks.
  10. Measurable disease as per RECIST 1.1 criteria.

Exclusion criteria

Exclusion Criteria:

  1. Patients with symptomatic central nervous system (CNS) metastases.
  2. Patients with any history of known or suspected autoimmune disease with the specific exceptions of vitiligo, atopic dermatitis, or psoriasis not requiring systemic treatment.
  3. History of prior allogeneic bone marrow, stem-cell or solid organ transplantation.
  4. Treatment with any systemic anti-neoplastic therapy, or investigational therapy within the 3 weeks prior to the initiation of study drug.
  5. Treatment with radiation therapy within 3 weeks prior to the initiation of study drug administration.
  6. Treatment with corticosteroids (≥10 mg per day prednisone or equivalent) or other immune suppressive drugs within the 14 days prior to the initiation of study drug administration.
  7. History of clinically-significant cardiovascular disease.
  8. Clinically-significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation.
  9. History of (non-infectious) pneumonitis that required steroids or presence of active pneumonitis
  10. Clinically-significant gastrointestinal disorders, such as perforation, gastrointestinal bleeding, or diverticulitis.
  11. Evidence of active viral, bacterial, or systemic fungal infection.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
95 participants (actual)

Study arms

  • Experimental
    Cohort 1: Margetuximab 10 mg/kg plus pembrolizumab 200 mg

    margetuximab administered in combination with pembrolizumab

    Biological: Margetuximab 10 mg/kg · Biological: Pembrolizumab

  • Experimental
    Cohort 2: Margetuximab 15 mg/kg plus pembrolizumab 200 mg

    margetuximab administered in combination with pembrolizumab

    Biological: Margetuximab 15 mg · Biological: Pembrolizumab

Interventions

  • BiologicalMargetuximab 10 mg/kg

    Margetuximab treatment is administered intravenously (IV) once every 21-day cycle

    Also known as: MGAH22

  • BiologicalMargetuximab 15 mg

    Margetuximab treatment is administered IV once every 21-day cycle

    Also known as: MGAH22

  • BiologicalPembrolizumab

    Pembrolizumab treatment is administered IV once every 21-day cycle

    Also known as: MK-3475

06

What researchers measure

Primary outcomes

  1. Number of Patients With Dose Limiting Toxicities

    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

  2. Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs).

    The number of patients that experience either an AE or a SAE during the study participation

    Time frame: up to 24 months

  3. Number of Patients With a Complete Response (CR) or Partial Response (PR) to Treatment

    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

  4. Number of Patients With a Complete Response (CR) or Partial Response (PR) to Treatment Using irRC Criteria

    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

  5. Duration of Response

    Duration of response is calculated at the time from CR or PR to relapse or cancer progression.

    Time frame: up to 24 months

Secondary outcomes

  1. Overall Survival (OS)

    The median length of time between first dose of study medication and death from any cause.

    Time frame: 24 Months

  2. Progression Free Survival (PFS)

    The interval between the first dose of study medication and progression of disease or death from any cause.

    Time frame: 24 Months

  3. Change From Baseline in Pharmacodynamic Markers in Whole Blood

    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

  4. Analysis of HER2 Tumor Cell Membrane Expression in Biopsy Specimens Before and After Treatment

    Time frame: from first dose to the end of treatment, average 12 months.

  5. Number of Patients Who Develop Treatment-emergent Anti-drug Antibodies to Margetuximab (Immunogenicity)

    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

  6. Maximum Concentration of Margetuximab at Steady State

    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

  7. Area Under the Concentration Time Curve at Steady State (AUC ss)

    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

  8. Clearance

    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.

  9. Volume of Distribution at Steady State

    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 .

  10. Terminal Half-life

    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 .

07

Results

Posted Aug 4, 2022

Participant flow

Participant flow — Overall Study
MilestoneMargetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Started392
Completed05
Not completed387
Withdrew: Adverse event18
Withdrew: Death01
Withdrew: Physician decision12
Withdrew: Withdrawal by subject01
Withdrew: Progression of cancer172
Withdrew: Decreased heart function01
Withdrew: Concern for anemia01
Withdrew: No measurable cancer for evaluation01

Outcome measures

PrimaryNumber of Patients With Dose Limiting Toxicities

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
Reported as:
Count of participants · Participants
Number of Patients With Dose Limiting Toxicities
ParticipantsMargetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Number of Patients With Dose Limiting Toxicities00
PrimaryNumber of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs).

The number of patients that experience either an AE or a SAE during the study participation

Time frame:
up to 24 months
Reported as:
Count of participants · Participants
Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs).
ParticipantsMargetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Number of Patients With Adverse Events (AEs) and Serious Adverse Events (SAEs).386
PrimaryNumber of Patients With a Complete Response (CR) or Partial Response (PR) to Treatment

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
Reported as:
Count of participants · Participants
Number of Patients With a Complete Response (CR) or Partial Response (PR) to Treatment
ParticipantsMargetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Number of Patients With a Complete Response (CR) or Partial Response (PR) to Treatment018
PrimaryNumber of Patients With a Complete Response (CR) or Partial Response (PR) to Treatment Using irRC Criteria

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
Reported as:
Count of participants · Participants
Number of Patients With a Complete Response (CR) or Partial Response (PR) to Treatment Using irRC Criteria
ParticipantsMargetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Number of Patients With a Complete Response (CR) or Partial Response (PR) to Treatment Using irRC Criteria019
PrimaryDuration of Response

Duration of response is calculated at the time from CR or PR to relapse or cancer progression.

Time frame:
up to 24 months
Reported as:
Median · months
Duration of Response
monthsMargetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Duration of Response—12.1 (2.79 to 26.68)
SecondaryOverall Survival (OS)

The median length of time between first dose of study medication and death from any cause.

Time frame:
24 Months
Reported as:
Median · months
Overall Survival (OS)
monthsMargetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Overall Survival (OS)7.0 (2.37 to 9.66)12.7 (9.07 to 14.62)
SecondaryProgression Free Survival (PFS)

The interval between the first dose of study medication and progression of disease or death from any cause.

Time frame:
24 Months
Reported as:
Median · months
Progression Free Survival (PFS)
monthsMargetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Progression Free Survival (PFS)1.4 (1.31 to 2.76)2.7 (0.37 to 4.34)
SecondaryChange From Baseline in Pharmacodynamic Markers in Whole Blood

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

No measurements were reported for this outcome.

SecondaryAnalysis of HER2 Tumor Cell Membrane Expression in Biopsy Specimens Before and After Treatment
Time frame:
from first dose to the end of treatment, average 12 months.

No measurements were reported for this outcome.

SecondaryNumber of Patients Who Develop Treatment-emergent Anti-drug Antibodies to Margetuximab (Immunogenicity)
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
Reported as:
Count of participants · Participants
Number of Patients Who Develop Treatment-emergent Anti-drug Antibodies to Margetuximab (Immunogenicity)
ParticipantsMargetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Number of Patients Who Develop Treatment-emergent Anti-drug Antibodies to Margetuximab (Immunogenicity)14
SecondaryMaximum Concentration of Margetuximab at Steady State

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
Reported as:
Geometric mean · mcg/mL
Maximum Concentration of Margetuximab at Steady State
mcg/mLMargetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Maximum Concentration of Margetuximab at Steady State197 ± 0.249318 ± 0.168
SecondaryArea Under the Concentration Time Curve at Steady State (AUC ss)

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
Reported as:
Geometric mean · mcg/mL* day
Area Under the Concentration Time Curve at Steady State (AUC ss)
mcg/mL* dayMargetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Area Under the Concentration Time Curve at Steady State (AUC ss)1710 ± 0.3582720 ± 0.329
SecondaryClearance

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.
Reported as:
Geometric mean · liters per day
Clearance
liters per dayMargetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Clearance0.381 ± 0.03940.329 ± 0.296
SecondaryVolume of Distribution at Steady State

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 .
Reported as:
Geometric mean · liters
Volume of Distribution at Steady State
litersMargetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Volume of Distribution at Steady State7.7 ± 0.3066.37 ± 0.205
SecondaryTerminal Half-life

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 .
Reported as:
Geometric mean · day
Terminal Half-life
dayMargetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Terminal Half-life17.2 ± 0.31216.2 ± 0.286

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)3/3 (100%)2/3 (66.7%)3/3 (100%)
Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)69/92 (75%)38/92 (41.3%)86/92 (93.5%)
Most frequent serious events
Showing 10 of 49
Most frequent serious events
EventMargetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
Infective exacerbation of chronic obstructive airways diseaseInfections and infestations1/30/92
Pain in extremityMusculoskeletal and connective tissue disorders1/30/92
Acute respiratory failureRespiratory, thoracic and mediastinal disorders1/30/92
AnaemiaBlood and lymphatic system disorders0/39/92
Obstruction gastricGastrointestinal disorders0/34/92
Gastric haemorrhageGastrointestinal disorders0/32/92
Oesophageal haemorrhageGastrointestinal disorders0/32/92
Small intestinal obstructionGastrointestinal disorders0/32/92
Upper gastrointestinal haemorrhageGastrointestinal disorders0/32/92
PyrexiaGeneral disorders0/32/92
Most frequent other events
Showing 10 of 35
Most frequent other events
EventMargetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)
DiarrhoeaGastrointestinal disorders1/326/92
ConstipationGastrointestinal disorders1/310/92
FatigueGeneral disorders1/325/92
Infusion related reactionInjury, poisoning and procedural complications1/312/92
Decreased appetiteMetabolism and nutrition disorders1/316/92
Back painMusculoskeletal and connective tissue disorders1/312/92
ArthralgiaMusculoskeletal and connective tissue disorders1/35/92
AnaemiaBlood and lymphatic system disorders0/329/92
NauseaGastrointestinal disorders0/323/92
PruritusSkin and subcutaneous tissue disorders0/318/92

Baseline characteristics

Age, Continuous
Age, Continuous(years)Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)Total
Mean62.7 ± 9.8760.2 ± 12.8360.3 ± 12.71
Sex: Female, Male
Sex: Female, Male(Participants)Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)Total
Female01717
Male37578
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)Total
Hispanic or Latino022
Not Hispanic or Latino38891
Unknown or Not Reported022
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)Total
American Indian or Alaska Native011
Asian05151
Native Hawaiian or Other Pacific Islander000
Black or African American033
White33437
More than one race011
Unknown or Not Reported022
Region of Enrollment
Region of Enrollment(participants)Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)Total
Canada033
South Korea04242
Singapore088
United States33841
Taiwan011
ECOG Performance Status
ECOG Performance Status(participants)Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)Total
003333
135962
Primary tumor location
Primary tumor location(participants)Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)Total
Gastric06161
Gastroesophageal junction33134
HER2 status using immunohistochemistry (IHC)
HER2 status using immunohistochemistry (IHC)(Participants)Margetuximab (10 mg/kg) Plus Pembrolizumab (200 mg)Margetuximab (15 mg/kg) Plus Pembrolizumab (200 mg)Total
IHC 2+22123
IHC 3+17172

2 further baseline measures are reported on the registry.

08

Study locations

28 sites
  • Yale School of Medicine
    New Haven, Connecticut 06520, United States
  • Georgetown University-Lombardi Comprehensive Cancer Center
    Washington, District of Columbia 20007, United States
  • University of Chicago
    Chicago, Illinois 60637, United States
  • Johns Hopkins University Medical Center
    Baltimore, Maryland 21231, United States
  • Dana-Farber Cancer Institute/Harvard University Medical Center
    Boston, Massachusetts 02215, United States
  • Karmanos Cancer Institute
    Detroit, Michigan 48201, United States
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania 19107, United States
  • Sarah Cannon Research Institute
    Nashville, Tennessee 37203, United States
  • Swedish Cancer Institute
    Seattle, Washington 98104, United States
  • Juravinski Cancer Centre - McMaster University
    Hamilton, Ontario L8V5C2, Canada
  • McGill University Health Centre
    Montreal, Quebec H4A3J1, Canada
  • Kyungbuk National University Hospital
    Daegu, 41404, Korea, Republic of
  • Gachon University Gil Medical Center
    Incheon, 21565, Korea, Republic of
  • Chonbuk National University Hospital
    Seoul, 54907, Korea, Republic of
  • Asan Medical Center
    Seoul, Korea, Republic of
  • Korea University Anam Hospital
    Seoul, Korea, Republic of
  • Korea University Guro Hospital
    Seoul, Korea, Republic of
  • Samsung Medical Center
    Seoul, Korea, Republic of
  • Seoul National University Bundang Hospital
    Seoul, Korea, Republic of
  • Seoul National University Hospital
    Seoul, Korea, Republic of
  • National Cancer Centre
    Singapore, Singapore
  • National University Hospital
    Singapore, Singapore
  • Raffles Hospital
    Singapore, Singapore
  • National Taiwan University Hospital
    Taipei, Taiwan
  • Taipei Veterans General Hospital
    Taipei, Taiwan
  • Tri-Service General Hospital
    Taipei, Taiwan
09

References and documents

Publications

  • 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. PubMed 32653053 ↗

Study documents

  • Study protocol · Jun 29, 2020
  • Statistical analysis plan · Dec 17, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02689284
Lead sponsor
MacroGenics
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Feb 23, 2016
Start date
Jan 2016
Primary completion
Jan 2021
Completion
Jan 2021
Results posted
Aug 4, 2022
Last update
Mar 17, 2025

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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