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Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer (MAHOGANY)

Primary Purpose

Gastric Cancer, Gastroesophageal Junction Cancer, HER2-positive Gastric Cancer

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
margetuximab
Retifanlimab
Tebotelimab
Trastuzumab
Chemotherapy
Sponsored by
MacroGenics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Histologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic HER2+ GC or GEJ adenocarcinoma

    1. Prior systemic perioperative treatment is allowed; however the patient must have had a disease-free interval of at least 6 months from end of chemo/surgery
    2. Patients receiving perioperative anti-HER2 therapy require testing of HER2 status for eligibility
    3. Cohort A: HER2-positive (by IHC 3+) and PD-L1-positive (by IHC with 22C3 CPS ≥ 1%) per central review
    4. Cohort B: HER2-positive (by IHC 3+ or IHC 2+ in combination with FISH+) by local review. PD -L1 status is not required for enrollment.
  • Availability of formalin-fixed, paraffin-embedded tumor specimen, unstained slides or contemporaneous biopsy for tumor target testing
  • Eastern Cooperative Oncology Group performance status of 0 or 1, verified within 3 days of Day 1
  • Life expectancy ≥ 6 months
  • At least one radiographically measurable target lesion
  • Acceptable laboratory parameters and adequate organ function

Key Exclusion Criteria:

  • Other malignancy that is progressing or required treatment within the past 5 years, with certain exceptions

    • Patients with known MSI-H status
  • History of allogeneic stem cell or tissue/solid organ transplant
  • Central nervous system metastases

  • Clinically significant cardiovascular disease, gastrointestinal disorders, pulmonary compromise

    • Prior neoadjuvant or adjuvant treatment with immunotherapy

Sites / Locations

  • Mayo Clinic - Scottsdale
  • City of Hope Comprehensive Cancer Center - Duarte
  • Norris Comprehensive Cancer Center (USC)
  • Salinas Memorial
  • UCLA School of Medicine
  • Yale University
  • Florida Cancer Specialists South
  • Mayo Clinic - Jacksonville
  • Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala
  • Florida Cancer Specialists North
  • Kaiser Permanente
  • University of Chicago
  • Edward H. Kaplan MD & Associates
  • Massachusetts General Hospital Cancer Center
  • Henry Ford Health System
  • Cancer & Hematology Centers of Western Michigan - Lemmen-Holton Cancer Pavilion
  • Mayo Clinic - Rochester
  • Washington University School of Medicine
  • Nebraska Heme Onc
  • Rutgers Cancer Institute of New Jersey
  • The University of New Mexico Comprehensive Cancer Center
  • Stephenson Cancer Center at OUHSC
  • Sarah Cannon Research Institute
  • Oncology Consultants
  • Utah Cancer Specialists
  • Virginia Cancer Specialists
  • Swedish Cancer Institute
  • University of Wisconsin
  • Beijing Cancer Hospital
  • Jilin Cancer Hospital (Second People's Hospital Of Jilin Province)
  • Fujian Medical University - Fujian Provincial Cancer Hospital (Fujian Provincial Tumor Hospital)
  • SIR RUN RUN SHAW Hospital, Zhejiang University school of medicine
  • Zhejiang Cancer Hospital
  • Affiliated Tumor Hospital of Harbin Medical University- the 3rd Affiliated Hospital of Harbin
  • The First Affiliated Hospital of Anhui Medical University
  • Anhui Provincial Cancer Hospital
  • Jinan Center Hospital
  • Nanjing University Medical School; Nanjing Drug Tower
  • Zhongshan Hospital Fudan University
  • Liaoning cancer hospital
  • Hebei cancer hospital (The Fourth Affiliate)
  • Wuhan Union Hospital
  • Henan Cancer Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • Institute of Clinical Cancer Research Krankenhaus Nordwest (IKF)
  • Haematologisch-Onkologische Praxis Eppendorf
  • Universitätsmedizin Mainz
  • Kliniken Maria Hilf GmbH
  • Ospedale San Raffaele
  • Istituto Europeo Di Oncologia
  • Azienda Ospedaliero-Universitaria Pisana
  • Hallym University Sacred Heart Hospital
  • CHA bundang
  • Inje University Haeundae Paik Hospital
  • Seoul National University Bundang Hospital
  • Asan Medical Center
  • Korea University Guro
  • Korea University, Anam Hospital
  • Samsung Medical Center
  • Seoul National University Hospital
  • Yonsei University College of Medicine (Severance Hospital)
  • Catholic University of Korea St. Vincent Hospital
  • SPSK nr 1 in Lublin
  • Centrum Medyczne MrukMed
  • National University Hospital (Cancer Institute) -Singapore
  • National Cancer Center Singapore
  • Taipei Medical University Hospital
  • Kaohsiung Chang Gung MemorialHospital
  • Chang Gung Memorial Hospital, Keelung
  • Liuying Chi MeiMedical Hospital
  • National Taiwan University
  • Cambridge University Hospitals NHS Foundation Trust Addenbrooke's Hospital
  • The Christie Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Chemotherapy-free arm

Margetuximab, retifanlimab, and chemotherapy arm

Margetuximab, tebotelimab and chemotherapy arm

Margetuximab and chemotherapy arm

Trastuzumab and chemotherapy arm

Arm Description

margetuximab plus retifanlimab

margetuximab plus retifanlimab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6)

margetuximab plus tebotelimab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6)

margetuximab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6)

Trastuzumab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6)

Outcomes

Primary Outcome Measures

Incidence of Adverse Events of margetuximab plus retifanlimab as assessed by CTCAE v5.0
Evaluation of adverse events and serious adverse events (Cohort A)
Objective response rate (ORR) for non-microsatellite instability-high (non-MSI-H) patients (Cohort A)
Proportion of non MSI-H patients with best overall response of complete response (CR) plus partial response (PR) per RECIST 1.1 (Cohorts A )

Secondary Outcome Measures

Progression-free survival
Time from start of study treatment to the first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first. (Cohorts A)
Duration of response
Time from the date of initial response (CR or PR) to the date of first documented progression or death from any cause, whichever occurs first (Cohorts A)
Disease control rate
Percentage of patients who experienced response of CR, PR or stable disease for at least 3 months from start of study treatment (Cohorts A and B)
ORR for Cohort B
Proportion of non-MSI-high patients iwth best overall response of CR plus PR per RECIST 1.1
Number of patients who have antidrug antibodies (ADA) to margetuximab
Number of patients who have ADA to retifanlimab
Number of patients who have ADA to tebotelimab

Full Information

First Posted
September 5, 2019
Last Updated
September 7, 2023
Sponsor
MacroGenics
Collaborators
Zai Lab (Shanghai) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04082364
Brief Title
Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer
Acronym
MAHOGANY
Official Title
A Phase 2/3 Trial to Evaluate Margetuximab in Combination With INCMGA00012 and Chemotherapy or MGD013 and Chemotherapy in Patients With Metastatic or Locally Advanced, Treatment-naïve, HER2-Positive Gastric or Gastroesophageal Junction Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MacroGenics
Collaborators
Zai Lab (Shanghai) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a Phase 2/3, randomized, open-label study for the treatment of patients with HER2-positive Gastric cancer (GC) or Gastroesophageal Junction (GEJ) cancer conducted in two parts. Part A is a single-arm cohort (Cohort A, 40 to 110 patients) will evaluate safety and efficacy of margetuximab plus retifanlimab. Part B has 2 subparts. Cohort B1 has 4 arms (50 patients/arm). Patients will be randomized to margetuximab plus retifanlimab plus chemotherapy, margetuximab plus tebotelimab, plus chemotherapy, margetuximab plus chemotherapy, or trastuzumab plus chemotherapy. The most effective combination with margetuximab from Cohort B1 will be used in Cohort B2. Cohort B2 has 2 arms (250 patients/arm). Patients will be randomized to margetuximab plus retifanlimab or tebotelimab plus chemotherapy, or to trastuzumab plus chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Gastroesophageal Junction Cancer, HER2-positive Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Cohort A is a single-arm cohort to evaluate safety and efficacy of margetuximab plus retifanlimab. Cohort B Part 1 is a randomized, 4-arm segment to evaluate margetuximab plus retifanlimab plus chemotherapy, margetuximab plus tebotelimab plus chemotherapy, margetuximab plus chemotherapy, vs trastuzumab plus chemotherapy. Cohort B Part 2 is a randomized, 2-arm segment to evaluate margetuximab plus the selected checkpoint inhibitor from Part 1, plus chemotherapy vs. trastuzumab plus chemotherapy.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy-free arm
Arm Type
Experimental
Arm Description
margetuximab plus retifanlimab
Arm Title
Margetuximab, retifanlimab, and chemotherapy arm
Arm Type
Experimental
Arm Description
margetuximab plus retifanlimab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6)
Arm Title
Margetuximab, tebotelimab and chemotherapy arm
Arm Type
Experimental
Arm Description
margetuximab plus tebotelimab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6)
Arm Title
Margetuximab and chemotherapy arm
Arm Type
Experimental
Arm Description
margetuximab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6)
Arm Title
Trastuzumab and chemotherapy arm
Arm Type
Active Comparator
Arm Description
Trastuzumab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6)
Intervention Type
Biological
Intervention Name(s)
margetuximab
Other Intervention Name(s)
MGAH22, Margenza®
Intervention Description
margetuximab: Fc-modified anti-HER2 monoclonal antibody: 15 mg/kg IV, Day1 of each 3-week cycle
Intervention Type
Biological
Intervention Name(s)
Retifanlimab
Other Intervention Name(s)
MGA012, INCMGA00012
Intervention Description
Retifanlimab: anti-PD-1 checkpoint inhibitor 375 mg IV, Day 1 of each 3-week cycle.
Intervention Type
Biological
Intervention Name(s)
Tebotelimab
Other Intervention Name(s)
MGD013
Intervention Description
Tebotelimab: anti PD-1, anti-LAG3 bispecific DART (R) molecule 600 mg IV, Day 1 of each 3-week cycle.
Intervention Type
Biological
Intervention Name(s)
Trastuzumab
Other Intervention Name(s)
Herceptin
Intervention Description
Anti-HER2 monoclonal antibody 8 mg/kg loading dose and then 6 mg/kg administered IV on Day 1 of each 3-week cycle
Intervention Type
Other
Intervention Name(s)
Chemotherapy
Intervention Description
Investigator choice of 1 of 2 chemotherapy regimens: XELOX or mFOLFOX6 Chemotherapy XELOX chemotherapy Capecitabine: 1000 mg/m2 as oral capsules twice a day Days 1-14 of each cycle, Oxaliplatin: 130 mg/m2 of Day 1 of each 3-week cycle as IV infusion mFOLFOX6 chemotherapy: Leucovorin: 400 mg/m2 every 2 weeks as IV infusion, 5-FU bolus: 400 mg/m2 every 2 weeks as IV infusion, 5-FU continuous infusion: 2400 mg/m2 every 2 weeks as a 46 hr infusion, Oxaliplatin: 85 mg/m2 every 2 weeks as IV infusion.
Primary Outcome Measure Information:
Title
Incidence of Adverse Events of margetuximab plus retifanlimab as assessed by CTCAE v5.0
Description
Evaluation of adverse events and serious adverse events (Cohort A)
Time Frame
Throughout the study up to 24 months
Title
Objective response rate (ORR) for non-microsatellite instability-high (non-MSI-H) patients (Cohort A)
Description
Proportion of non MSI-H patients with best overall response of complete response (CR) plus partial response (PR) per RECIST 1.1 (Cohorts A )
Time Frame
Throughout the study up to 24 months
Secondary Outcome Measure Information:
Title
Progression-free survival
Description
Time from start of study treatment to the first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first. (Cohorts A)
Time Frame
Up to 3 years
Title
Duration of response
Description
Time from the date of initial response (CR or PR) to the date of first documented progression or death from any cause, whichever occurs first (Cohorts A)
Time Frame
Up to 3 years
Title
Disease control rate
Description
Percentage of patients who experienced response of CR, PR or stable disease for at least 3 months from start of study treatment (Cohorts A and B)
Time Frame
Up to 3 years
Title
ORR for Cohort B
Description
Proportion of non-MSI-high patients iwth best overall response of CR plus PR per RECIST 1.1
Time Frame
Throughout study participation, up to 24 months.
Title
Number of patients who have antidrug antibodies (ADA) to margetuximab
Time Frame
Throughout study participation, up to 24 months.
Title
Number of patients who have ADA to retifanlimab
Time Frame
Throughout study participation, up to 24 months.
Title
Number of patients who have ADA to tebotelimab
Time Frame
Throughout study participation, up to 24 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Histologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic HER2+ GC or GEJ adenocarcinoma Prior systemic perioperative treatment is allowed; however the patient must have had a disease-free interval of at least 6 months from end of chemo/surgery Patients receiving perioperative anti-HER2 therapy require testing of HER2 status for eligibility Cohort A: HER2-positive (by IHC 3+) and PD-L1-positive (by IHC with 22C3 CPS ≥ 1%) per central review Cohort B: HER2-positive (by IHC 3+ or IHC 2+ in combination with FISH+) by local review. PD -L1 status is not required for enrollment. Availability of formalin-fixed, paraffin-embedded tumor specimen, unstained slides or contemporaneous biopsy for tumor target testing Eastern Cooperative Oncology Group performance status of 0 or 1, verified within 3 days of Day 1 Life expectancy ≥ 6 months At least one radiographically measurable target lesion Acceptable laboratory parameters and adequate organ function Key Exclusion Criteria: Other malignancy that is progressing or required treatment within the past 5 years, with certain exceptions Patients with known MSI-H status History of allogeneic stem cell or tissue/solid organ transplant Central nervous system metastases Clinically significant cardiovascular disease, gastrointestinal disorders, pulmonary compromise Prior neoadjuvant or adjuvant treatment with immunotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen L. Eck, MD, PhD
Organizational Affiliation
MacroGenics
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic - Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
City of Hope Comprehensive Cancer Center - Duarte
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Norris Comprehensive Cancer Center (USC)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Salinas Memorial
City
Salinas
State/Province
California
ZIP/Postal Code
93901
Country
United States
Facility Name
UCLA School of Medicine
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Florida Cancer Specialists South
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Florida Cancer Specialists North
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Kaiser Permanente
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Edward H. Kaplan MD & Associates
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Cancer & Hematology Centers of Western Michigan - Lemmen-Holton Cancer Pavilion
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Nebraska Heme Onc
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
The University of New Mexico Comprehensive Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Stephenson Cancer Center at OUHSC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Oncology Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Virginia Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Jilin Cancer Hospital (Second People's Hospital Of Jilin Province)
City
Changchun
ZIP/Postal Code
130000
Country
China
Facility Name
Fujian Medical University - Fujian Provincial Cancer Hospital (Fujian Provincial Tumor Hospital)
City
Fuzhou
ZIP/Postal Code
350005
Country
China
Facility Name
SIR RUN RUN SHAW Hospital, Zhejiang University school of medicine
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
ZIP/Postal Code
310022
Country
China
Facility Name
Affiliated Tumor Hospital of Harbin Medical University- the 3rd Affiliated Hospital of Harbin
City
Harbin
ZIP/Postal Code
150081
Country
China
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
ZIP/Postal Code
230022
Country
China
Facility Name
Anhui Provincial Cancer Hospital
City
Hefei
ZIP/Postal Code
230031
Country
China
Facility Name
Jinan Center Hospital
City
Jinan
ZIP/Postal Code
250013
Country
China
Facility Name
Nanjing University Medical School; Nanjing Drug Tower
City
Nanjing
ZIP/Postal Code
210000
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Liaoning cancer hospital
City
Shenyang
ZIP/Postal Code
110042
Country
China
Facility Name
Hebei cancer hospital (The Fourth Affiliate)
City
Shijiazhuang
ZIP/Postal Code
050000
Country
China
Facility Name
Wuhan Union Hospital
City
Wuhan
ZIP/Postal Code
430022
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhenzhou
ZIP/Postal Code
450052
Country
China
Facility Name
Institute of Clinical Cancer Research Krankenhaus Nordwest (IKF)
City
Frankfurt
ZIP/Postal Code
60488
Country
Germany
Facility Name
Haematologisch-Onkologische Praxis Eppendorf
City
Hamburg
Country
Germany
Facility Name
Universitätsmedizin Mainz
City
Mainz
Country
Germany
Facility Name
Kliniken Maria Hilf GmbH
City
Monchengladbach
Country
Germany
Facility Name
Ospedale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Istituto Europeo Di Oncologia
City
Milan
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Pisana
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang-Si
ZIP/Postal Code
14068
Country
Korea, Republic of
Facility Name
CHA bundang
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Inje University Haeundae Paik Hospital
City
Haeundae
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University, Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University College of Medicine (Severance Hospital)
City
Seoul
Country
Korea, Republic of
Facility Name
Catholic University of Korea St. Vincent Hospital
City
Suwon
Country
Korea, Republic of
Facility Name
SPSK nr 1 in Lublin
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Centrum Medyczne MrukMed
City
Rzeszów
ZIP/Postal Code
35-922
Country
Poland
Facility Name
National University Hospital (Cancer Institute) -Singapore
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
National Cancer Center Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Taipei Medical University Hospital
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
110
Country
Taiwan
Facility Name
Kaohsiung Chang Gung MemorialHospital
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital, Keelung
City
Keelung
ZIP/Postal Code
204
Country
Taiwan
Facility Name
Liuying Chi MeiMedical Hospital
City
Tainan city
ZIP/Postal Code
73657
Country
Taiwan
Facility Name
National Taiwan University
City
Taipei
Country
Taiwan
Facility Name
Cambridge University Hospitals NHS Foundation Trust Addenbrooke's Hospital
City
Cambridge
Country
United Kingdom
Facility Name
The Christie Hospital NHS Foundation Trust
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33263418
Citation
Catenacci DV, Rosales M, Chung HC, H Yoon H, Shen L, Moehler M, Kang YK. MAHOGANY: margetuximab combination in HER2+ unresectable/metastatic gastric/gastroesophageal junction adenocarcinoma. Future Oncol. 2021 Apr;17(10):1155-1164. doi: 10.2217/fon-2020-1007. Epub 2020 Dec 2.
Results Reference
derived

Learn more about this trial

Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer

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