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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
MacroGenics
Study ID
NCT04082364
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Gastric Cancer
  • Gastroesophageal Junction Cancer
  • HER2-positive Gastric Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • margetuximab — BIOLOGICAL
    margetuximab: Fc-modified anti-HER2 monoclonal antibody: 15 mg/kg IV, Day1 of each 3-week cycle
  • Retifanlimab — BIOLOGICAL
    Retifanlimab: anti-PD-1 checkpoint inhibitor 375 mg IV, Day 1 of each 3-week cycle.
  • Tebotelimab — BIOLOGICAL
    Tebotelimab: anti PD-1, anti-LAG3 bispecific DART (R) molecule 600 mg IV, Day 1 of each 3-week cycle.
  • Trastuzumab — BIOLOGICAL
    Anti-HER2 monoclonal antibody 8 mg/kg loading dose and then 6 mg/kg administered IV on Day 1 of each 3-week cycle
  • Chemotherapy — OTHER
    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.

Study Details

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 participants) will evaluate safety and efficacy of margetuximab plus retifanlimab. Part B Part 1 has 4 arms (50 patients/arm). Participants will be randomized to margetuximab plus retifanlimab plus chemotherapy, margetuximab plus tebotelimab, plus chemotherapy, margetuximab plus chemotherapy, or trastuzumab plus chemotherapy.

Key Dates

Start date
Sep 30, 2019
Status verified
May 2025
Primary completion
Jan 15, 2024
Completion
Mar 25, 2025

Study Design

Enrollment
82 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Chemotherapy-free arm
    margetuximab plus retifanlimab
  • Experimental: Margetuximab, retifanlimab, and chemotherapy arm
    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)
  • Experimental: Margetuximab, tebotelimab and chemotherapy arm
    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)
  • Experimental: Margetuximab and chemotherapy arm
    margetuximab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6)
  • Active Comparator: Trastuzumab and chemotherapy arm
    Trastuzumab plus investigator choice of chemotherapy options. Chemotherapy options: capecitabine and oxaliplatin (XELOX) or modified 5-FU, leucovorin, and oxaliplatin regimen 6 (mFOLFOX-6)

Primary Outcome Measure

Number of Participants With Adverse Events of Margetuximab Plus Retifanlimab in Cohort A, as Assessed by CTCAE v5.0 [ Time Frame: Throughout the study, an average of 11 months. ]

Locations (28)

FacilityCityStateZIPSite coordinators
Mayo Clinic - ScottsdaleScottsdaleArizona85259-
City of Hope Comprehensive Cancer Center - DuarteDuarteCalifornia91010-
Norris Comprehensive Cancer Center (USC)Los AngelesCalifornia90033-
Salinas MemorialSalinasCalifornia93901-
UCLA School of MedicineSanta MonicaCalifornia90404-
Yale UniversityNew HavenConnecticut06511-
Florida Cancer Specialists SouthFort MyersFlorida33901-
Mayo Clinic - JacksonvilleJacksonvilleFlorida32224-
Ocala Oncology Center PL DBA Florida Cancer Affiliates - OcalaOcalaFlorida34474-
Florida Cancer Specialists NorthSt. PetersburgFlorida33705-
Kaiser PermanenteHonoluluHawaii96814-
University of ChicagoChicagoIllinois60637-
Edward H. Kaplan MD & AssociatesSkokieIllinois60076-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-
Henry Ford Health SystemDetroitMichigan48202-
Cancer & Hematology Centers of Western Michigan - Lemmen-Holton Cancer PavilionGrand RapidsMichigan49503-
Mayo Clinic - RochesterRochesterMinnesota55905-
Washington University School of MedicineSt LouisMissouri63110-
Nebraska Heme OncLincolnNebraska68506-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
The University of New Mexico Comprehensive Cancer CenterAlbuquerqueNew Mexico87131-
Stephenson Cancer Center at OUHSCOklahoma CityOklahoma73104-
Sarah Cannon Research InstituteNashvilleTennessee37203-
Oncology ConsultantsHoustonTexas77030-
Utah Cancer SpecialistsSalt Lake CityUtah84106-
Virginia Cancer SpecialistsFairfaxVirginia22031-
Swedish Cancer InstituteSeattleWashington98104-
University of WisconsinMadisonWisconsin53792-

Find similar trials in Scottsdale, AZ

By condition
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Mayo Clinic - Scottsdale· Scottsdale, AZCity of Hope Comprehensive Cancer Center - Duarte· Duarte, CANorris Comprehensive Cancer Center (USC)· Los Angeles, CASalinas Memorial· Salinas, CAUCLA School of Medicine· Santa Monica, CAYale University· New Haven, CT

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