Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer (SOPHIA)

October 28, 2022 updated by: MacroGenics

A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment

The purpose of this study is to determine whether patients with metastatic breast cancer treated with margetuximab plus chemotherapy have longer progression free survival (PFS) and overall survival (OS) than patients treated with trastuzumab plus chemotherapy.

A non-randomized sub-study cohort of approximately 88 patients will be enrolled to evaluate the safety of a reduced margetuximab infusion rate in patients receiving margetuximab either as monotherapy or in combination with chemotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

624

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Medizinische Universitat Innsbruck
  • Belgium
      • Liège, Belgium, 4000
        • CHC - Clinique Saint-Joseph
      • Namur, Belgium, 5000
        • Clinique Sainte Elisabeth
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • UZ Antwerpen
      • Wilrijk, Antwerpen, Belgium, 2610
        • GZA Ziekenhuizen - Campus Sint-Augustinus
    • Brabant Wallon
      • Ottignies, Brabant Wallon, Belgium, 1340
        • Clinique Saint-Pierre Ottignies
    • Brussels Capital Region
      • Brussels, Brussels Capital Region, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Brussels, Brussels Capital Region, Belgium, 1090
        • UZ Brussel - Campus Jette
    • Limburg
      • Hasselt, Limburg, Belgium, 3500
        • Jessa Ziekenhuis - Campus Virga Jesse
    • Oost-Vlaanderen
      • Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
        • AZ Nikolaas - Campus Sint-Niklaas Moerland
    • West-Vlaanderen
      • Brugge, West-Vlaanderen, Belgium, 8000
        • AZ Sint-Jan Brugge - Oostende - Campus Sint-Jan
      • Kortrijk, West-Vlaanderen, Belgium, 8500
        • AZ Groeninge - Campus Loofstraat
      • Oostende, West-Vlaanderen, Belgium, 8400
        • AZ Damiaan
  • Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 8X3
        • Dr. Leon Richard Oncology Centre
    • Ontario
      • Oshawa, Ontario, Canada, L1G 2B9
        • Lakeridge Health Oshawa
  • Czechia
      • Olomouc, Czechia, 779 00
        • Fakultní nemocnice Olomouc
      • Praha 5, Czechia, 150 06
        • Fakultní nemocnice v Motole
    • Brno-město
      • Brno, Brno-město, Czechia, 656 53
        • Masarykuv onkologicky ustav
  • Denmark
    • Central Jutland
      • Aarhus C, Central Jutland, Denmark, 8000
        • Aarhus Universitetshospital
      • Herning, Central Jutland, Denmark, 7400
        • Regionshospitalet Herning (Herning Centralsygehus)
    • South Denmark
      • Vejle, South Denmark, Denmark, 7100
        • Vejle Sygehus
    • Zeeland
      • Aarhus N, Zeeland, Denmark, 4700
        • Næstved Sygehus
  • Finland
    • Etelä-Suomen Lääni
      • Tampere, Etelä-Suomen Lääni, Finland, 33521
        • Tampere University Hospital
    • Länsi-Suomen Lääni
      • Helsinki, Länsi-Suomen Lääni, Finland, 00029
        • Helsinki University Central Hospital (HUCH) - Meilahden Sair
  • France
    • Alpes-Martitimes
      • Nice, Alpes-Martitimes, France, 06189
        • Center de Lutte Contre le Cancer (CLCC)
    • Calvados
      • Caen cedex 05, Calvados, France, 14076
        • Center de Lutte Contre le Cancer (CLCC)
    • Côte-d'Or
      • Dijon, Côte-d'Or, France, 21079
        • Centre Georges-François Lecler
    • Loire-Atlantique
      • St Herblain, Loire-Atlantique, France, 44805
        • Centre de Lutte Contre le Cancer (CLCC) - Institut de Cancer
    • Puy-de-Dôme
      • Clermont-Ferrand, Puy-de-Dôme, France, 63011
        • Centre Jean Perrin
    • Rhône-Alpes
      • Lyon Cedex 08, Rhône-Alpes, France, 69373
        • Centre Léon Bérard
    • Île-de-France
      • Paris, Île-de-France, France, 75005
        • Institut Curie
      • Saint-Cloud, Île-de-France, France, 92210
        • Institut Curie - Hôpital René Huguenin
  • Germany
      • Heidelberg, Germany
        • Universtatsklinikum Heidelberg Nationales
    • Baden-Württemberg
      • Tuebingen, Baden-Württemberg, Germany, 72076
        • Universitaetsklinikum Tuebingen
    • Bayern
      • Erlangen, Bayern, Germany, 91054
        • Universitätsklinikum Erlangen
      • München, Bayern, Germany, 81925
        • Praxis für Frauenheilkunde Anita
    • Nordhein-Westfalen
      • Düsseldorf, Nordhein-Westfalen, Germany, 40479
        • Marien Hospital Dusseldorf
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45122
        • Universitaetsklinikum Essen - Klinik fuer Frauenheilkunde
      • Witten, Nordrhein-Westfalen, Germany, 58452
        • Marien Hospital
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Medizinische Fakultät Carl Gustav Carus
  • Israel
      • Haifa, Israel, 35152
        • Clalit Health Services - Lin Medical Center
      • Tel Aviv, Israel, 64239
        • Tel Aviv Sourasky Medical Center
    • HaDarom
      • Beersheba, HaDarom, Israel, 84802
        • Soroka Medical Center [Oncology]
    • HaMerkaz
      • Kfar Saba, HaMerkaz, Israel, 44281
        • Meir Medical Center
      • Petaẖ Tiqwa, HaMerkaz, Israel, 49100
        • Rabin Medical Center - Beilinson Hospital
      • Ramat Gan, HaMerkaz, Israel, 52621
        • The Chaim Sheba Medical Center - Insititute of Oncology
      • Rehovot, HaMerkaz, Israel, 761001
        • Kaplan Medical Center
    • Yerushalayim
      • Jerusalem, Yerushalayim, Israel, 91120
        • Hadassah Medical Organisation, Hadassah Medical Center, Ein-Karem
  • Italy
      • Ancona, Italy, 60126
        • Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc
      • Benevento, Italy, 82100
        • AO G.Rummo
      • Bergamo, Italy, 24127
        • ASST Papa Giovanni XXIII - Oncologia-Bergamo
      • Cremona, Italy, 26100
        • PO di Cremona, ASST di Cremona - Patologia Mammaria e Breast Unit - Cremona
      • Ferrara, Italy, 44124
        • Arcispedale S.Anna, AOU di Ferrara
      • Genova, Italy, 16128
        • E.O. Ospedali Galliera
      • Lecco, Italy, 23900
        • PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco
      • Milano, Italy, 20121
        • Azienda Ospedaliera Fatebenefratelli e Oftalmico
      • Milano, Italy, 20141
        • Istituto Europeo di Oncologia Via Ripamonti
      • Modena, Italy, 41122
        • AOU Policlinico di Modena
      • Napoli, Italy, 80131
        • Fondazione Pascale, IRCCS Istituto Nazionale dei Tumori
      • Parma, Italy, 43126
        • AOU di Parma
      • Pavia, Italy, 27100
        • IRCCS Policlinico San Matteo
      • Pavia, Italy, 27100
        • IRCSS Fodazione Salvatore Maugeri
      • Pisa, Italy, 56126
        • SO S.Chiara, AOU Pisana
      • Prato, Italy, 59100
        • Nuovo Ospedale di Prato
      • Roma, Italy, 00128
        • PU Campus Bio-medico di Roma
      • Roma, Italy, 00189
        • AO S.Andrea, Università degli Studi di Roma La Sapienza
      • Viterbo, Italy, 01100
        • Ospedale Belcolle Viterbo
    • Cantania
      • Catania, Cantania, Italy, 95122
        • PO Garibaldi-Nesima, ARNAS Garibaldi
    • Forli
      • Meldola, Forli, Italy, 47014
        • Irccs Irst
    • Torino
      • Candiolo, Torino, Italy, 10060
        • Istituto di Candiolo, IRCCS
    • Toscana
      • Siena, Toscana, Italy, 53100
        • Azienda Ospedaliero Universitaria Senese Universita degli St
  • Korea, Republic of
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05505
        • Asan Medical Center
  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Maastricht University Medical Centre
    • Zuid-Holland
      • Haag, Zuid-Holland, Netherlands, 2545 CH
        • Haga Ziekenhuis, loc. Leyenburg
  • Poland
      • Lublin, Poland, 20-090
        • Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 04-125
        • Magodent Sp. Z o.o.
      • Wieliszew, Mazowieckie, Poland, 05-135
        • Mazowiecki Szpital Onkologiczny
  • Portugal
      • Lisboa, Portugal, 1649-035
        • H. Santa Maria - Centro Hospitalar Lisboa Norte
      • Porto, Portugal, 4200-072
        • Instituto Português Oncologia Francisco Gentil do Porto
    • Lisboa
      • Lisbon, Lisboa, Portugal, 1400-038
        • Centro Clínico Champalimaud/Fundação Champalimaud
  • Puerto Rico
      • San Juan, Puerto Rico, 927
        • Fundacion de Investigacion de Diego
  • Spain
      • Barcelona, Spain, 08023
        • Hospital Universitario Vall d'Hebron
      • Cáceres, Spain, 10003
        • H. San Pedro de Alcántara
      • Lleida, Spain, 25198
        • H.U. Arnau de Vilanova
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28040
        • Hospital Universitario Clinico San Carlos
      • Madrid, Spain, 28033
        • M.D. Anderson Cancer Center Madrid
      • Valencia, Spain, 46009
        • Fundacion Instituto Valenciano de Oncologia
      • Valencia, Spain, 46026
        • Hospital Universitari i Politècnic La Fe
      • Ávila, Spain, 5004
        • Hospital Ntra. Sra. de Sonsoles
    • Andalucía
      • Sevilla, Andalucía, Spain, 41013
        • H.U.V. del Rocio
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Institut català d'oncologia-hospital germans trias i pujol
      • Sabadell, Barcelona, Spain, 08208
        • Hospital Universitari Parc Tauli
    • Catalunya
      • Barcelona, Catalunya, Spain, 08003
        • Hospital del Mar
    • Comunidad
      • Valencia, Comunidad, Spain, 46010
        • H.C.U. Valencia
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Hospital de Navarra
    • Tarragona
      • Reus, Tarragona, Spain, 43204
        • H.U. Sant Joan de Reus
  • United Kingdom
      • Middlesbrough, United Kingdom, TS4 3BW
        • South Tees Hospitals NHS Foundation Trust
    • City Of London
      • London, City Of London, United Kingdom, SE1 9RT
        • Guys and St Thomas Hospital
    • East Riding Of Yorkshire
      • Hull, East Riding Of Yorkshire, United Kingdom, HU16 5JQ
        • Castle Hill Hospital (Hull)
    • Kent
      • Maidstone, Kent, United Kingdom, ME16 9QQ
        • Kent Oncology Centre, Maidstone Hospital
    • Lancashire
      • Fulwood, Lancashire, United Kingdom, PR2 9HT
        • Royal Preston Hospital
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Ironwood Cancer & Research Center
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center
      • Goodyear, Arizona, United States, 85338
        • Western Regional Medical Center, Inc.
    • California
      • Burbank, California, United States, 91505
        • East Valley Hematology And Oncology
      • Los Angeles, California, United States, 90095
        • UCLA Hematology Oncology Santa Monica
      • Sacramento, California, United States, 95817
        • UC Davis Comprehensive Cancer Center
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
      • San Francisco, California, United States, 94115
        • University of California, San Francisco Helen Diller Family Comprehensive Cancer Center
      • Vallejo, California, United States, 94589
        • Kaiser Permenente Medical Center
    • Colorado
      • Fort Collins, Colorado, United States, 80528
        • Poudre Valley Health Care, Inc.
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • MedStar Washington Hospital Center
    • Florida
      • Fort Myers, Florida, United States, 33916
        • Florida Cancer Specialists
      • Hollywood, Florida, United States, 33021
        • Memorial Cancer Institute at Memorial Regional Hospital
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Comprehensive Cancer Center
      • New Port Richey, Florida, United States, 34655
        • Florida Cancer Specialists
      • Orlando, Florida, United States, 32806
        • Orlndo Health Cancer Center
      • Port Saint Lucie, Florida, United States, 34952
        • Hem-Onc Associates
      • West Palm Beach, Florida, United States, 33401
        • Palm Beach Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Piedmont Cancer Institute, P.C.
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers, PC
      • Newnan, Georgia, United States, 30265
        • CTCA - Southeastern Regional Medical Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • Kaiser Permanente Hawaii Moanalua Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
      • Zion, Illinois, United States, 60099
        • CTCA - Midwestern Regional Medical Center
    • Indiana
      • Goshen, Indiana, United States, 46526
        • Indiana University Health Goshen Center for Cancer Care
    • Kentucky
      • Hazard, Kentucky, United States, 41701
        • ARH Cancer Clinic
      • Lexington, Kentucky, United States, 40504
        • St. Joseph's Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Touro Infirmary Hospital
    • Maine
      • Scarborough, Maine, United States, 04074
        • New England Cancer Specialists
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts-NEMC Cancer Center
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Forrest General Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Cancer Specialists
      • Saint Louis, Missouri, United States, 63141
        • Mercy Hospital Saint Louis
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock - Norris C
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • New Jersey Hematology Oncology Associates
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Livingston, New Jersey, United States, 07039
        • Saint Barnabas Medical Center - The Cancer Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • New Mexico Cancer Care Alliance (NMCCA)
    • New York
      • Jamaica, New York, United States, 11432
        • Queens Hospital Center
      • Lake Success, New York, United States, 11042
        • ProHEALTH Care Associates, LLP
      • New York, New York, United States, 10016
        • New York University Clinical Cancer Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Baptist Medical Center (WFUBMC)
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Mercy Physicians Of Oklahoma
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17109
        • Pinnacle Health Cancer Institute
      • Monongahela, Pennsylvania, United States, 15063
        • Monongahela Valley Hospital
      • Philadelphia, Pennsylvania, United States, 19124
        • CTCA - Eastern Regional Medical Center, Inc.
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Medical Group, PC
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, United States, 37203
        • The Sarah Cannon Research Institute
    • Texas
      • Austin, Texas, United States, 78758
        • Austin Cancer Center
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Fort Worth, Texas, United States, 76104
        • The Center for Cancer and Blood Disorders
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Cancer Center
      • Fairfax, Virginia, United States, 22031
        • Inova Schar Cancer Institute
      • Fort Belvoir, Virginia, United States, 22060
        • Fort Belvoir Community Hospital
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute/ Swedish Health Services
      • Seattle, Washington, United States, 98109
        • University of Washington/ Seattle Cancer Care Alliance
      • Spokane, Washington, United States, 99202
        • Cancer Care Northwest, PS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically-proven metastatic or locally-advanced relapsed/refractory HER2+ breast cancer based on the most recently available tumor biopsy collected from the patient. Tumors may be estrogen receptor (ER)/progesterone receptor (PgR) positive or negative.
  • Have received at least 2 prior lines of anti-HER2 directed therapy in the metastatic setting, or in case of having received (neo)adjuvant pertuzumab, at least 1 prior line of anti-HER2 directed therapy in the metastatic setting. In either case, patients must have received prior treatment with pertuzumab, in the (neo)adjuvant or metastatic setting. Prior radiotherapy, hormonal therapies, and other anti-HER2 therapies are allowed.
  • Prior treatment with at least one, and no more than three, lines of therapy overall in the metastatic setting. Patients must have progressed on or following, the most recent line of therapy.
  • Resolution of all chemotherapy or radiation-related toxicities to ≤ Grade 1
  • Life expectancy ≥ 12 weeks
  • Acceptable laboratory parameters
  • Women of childbearing potential must have negative pregnancy test performed within 14 days of randomization and on the first day of treatment. All subjects must agree to use an effective form of contraception for the duration of study treatment and for 7 months after the last dose of study drug.

Infusion sub-study prior therapy requirements: Same as above, except:

  • Must have received 4 or more prior lines or therapy in the metastatic setting
  • Must have received prior trastuzumab, pertuzumab, and T-DM1

Exclusion Criteria:

  • Known, untreated brain metastasis. Patients with signs or symptoms of brain metastasis must have a CT or MRI performed within 4 weeks prior to randomization to specifically exclude the presence of radiographically-detected brain metastases
  • History of uncontrolled seizures within 6 months of randomization
  • History of prior allogeneic bone marrow, stem-cell, or solid organ transplantation
  • History of clinically significant cardiovascular disease
  • Clinically-significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation
  • Any condition that would be a contraindication to receiving trastuzumab as described in the approved local label or a condition that would prevent treatment with the physician's choice of chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Margetuximab plus chemotherapy
Margetuximab 15 mg/kg every 21 days
Biological: Margetuximab
15 mg/kg via IV (intravenous) infusion on day 1 of each 21 day cycle,
Other Names:
  • MGAH22
  • Margenza®
Drug: Physician's choice of chemotherapy.
Capecitabine (Xeloda®):1000 mg/m2 BID for 14 days in a 21-day cycle, or Eribulin (Halaven®): 1.4 mg/m2 on days 1 and 8 of a 21-day cycle, or Gemcitabine (Gemzar®): 1000 mg/m2 on days 1 and 8 of a 21-day cycle, or Vinorelbine (Navelbine®): 25-30 mg/m2 on days 1 and 8 of a 21-day cycle
Active Comparator: Trastuzumab plus chemotherapy
Trastuzumab 8 mg/kg loading dose, then 6 mg/kg every 21 days
Drug: Physician's choice of chemotherapy.
Capecitabine (Xeloda®):1000 mg/m2 BID for 14 days in a 21-day cycle, or Eribulin (Halaven®): 1.4 mg/m2 on days 1 and 8 of a 21-day cycle, or Gemcitabine (Gemzar®): 1000 mg/m2 on days 1 and 8 of a 21-day cycle, or Vinorelbine (Navelbine®): 25-30 mg/m2 on days 1 and 8 of a 21-day cycle
Biological: Trastuzumab
8 mg/kg via IV (intravenous) infusion for the first dose and 6 mg/kg for all subsequent doses via IV infusion on day 1 of each 21 day cycle
Other Names:
  • Herceptin®
Experimental: Margetuximab Infusion Sub-study
Margetuximab 15 mg/kg every 21 days (with or without chemotherapy), studying a shorter duration of infusion beginning in Cycle 2.
Biological: Margetuximab
15 mg/kg via IV (intravenous) infusion on day 1 of each 21 day cycle,
Other Names:
  • MGAH22
  • Margenza®
Drug: Physician's choice of chemotherapy.
Capecitabine (Xeloda®):1000 mg/m2 BID for 14 days in a 21-day cycle, or Eribulin (Halaven®): 1.4 mg/m2 on days 1 and 8 of a 21-day cycle, or Gemcitabine (Gemzar®): 1000 mg/m2 on days 1 and 8 of a 21-day cycle, or Vinorelbine (Navelbine®): 25-30 mg/m2 on days 1 and 8 of a 21-day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS) as Determined by Independent Radiological Review.
Time Frame: Tumor assessments are conducted every 6 weeks for the first 24 weeks and then every 24 weeks until progression of cancer, average 5 months.
PFS is measured from the time of randomization until first documented disease progression or death from any cause, whichever is first.
Tumor assessments are conducted every 6 weeks for the first 24 weeks and then every 24 weeks until progression of cancer, average 5 months.
Overall Survival (OS) Defined as the Number of Days From Randomization to the Date of Death (From Any Cause).
Time Frame: Throughout the study, average 21 months
Overall survival is the time from randomization until death from any cause
Throughout the study, average 21 months
Number of Patients With Grade 3 or Higher Infusion Related Reactions
Time Frame: 22 days
Incidence of Grade 3 or higher infusion-related reactions for patients receiving 60-minute or 30-minute infusions of margetuximab in Cycle 2 of treatment
22 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To Evaluate Progression-free Survival (PFS), as Assessed by Study Investigators.
Time Frame: Tumor assessments are conducted every 6 weeks for the first 24 weeks and then every 24 weeks until progression of cancer, up to 6.5 years.
Tumor assessments are conducted every 6 weeks for the first 24 weeks and then every 24 weeks until progression of cancer, up to 6.5 years.
To Evaluate the Objective Response Rate (ORR) as Determined by Independent Radiological Review.
Time Frame: Tumor assessments are conducted every 6 weeks for the first 24 weeks and then every 24 weeks until progression of cancer, up to 6.5 years.
Objective response rate includes all patients with either a complete response (CR) or a partial response (PR) to study treatment
Tumor assessments are conducted every 6 weeks for the first 24 weeks and then every 24 weeks until progression of cancer, up to 6.5 years.
Infusion Rate Sub-study All Safety
Time Frame: Throughout the study, average duration 6 months
Incidence of all grades of infusion-related reactions
Throughout the study, average duration 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MacroGenics

Investigators

  • Study Director: Stephen L Eck, M.D., Ph.D., MacroGenics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2015

Primary Completion (Actual)

August 11, 2021

Study Completion (Actual)

June 14, 2022

Study Registration Dates

First Submitted

July 6, 2015

First Submitted That Met QC Criteria

July 8, 2015

First Posted (Estimate)

July 9, 2015

Study Record Updates

Last Update Posted (Actual)

November 23, 2022

Last Update Submitted That Met QC Criteria

October 28, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-MGAH22-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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