Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer
Public ClinicalTrials.gov record NCT04082364. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04082364
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 82 participants
Conditions and interventions
Interventions
- margetuximab Biological
- Retifanlimab Biological
- Tebotelimab Biological
- Trastuzumab Biological
- Chemotherapy Other
Biological · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2019 (Actual)
- Primary completion
- Jan 15, 2024 (Actual)
- Completion
- Mar 25, 2025 (Actual)
- Last update posted
- Jun 8, 2025
2019 – 2025
United States locations
- U.S. sites
- 28
- U.S. states
- 20
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic - Scottsdale | Scottsdale | Arizona | 85259 | — |
| City of Hope Comprehensive Cancer Center - Duarte | Duarte | California | 91010 | — |
| Norris Comprehensive Cancer Center (USC) | Los Angeles | California | 90033 | — |
| Salinas Memorial | Salinas | California | 93901 | — |
| UCLA School of Medicine | Santa Monica | California | 90404 | — |
| Yale University | New Haven | Connecticut | 06511 | — |
| Florida Cancer Specialists South | Fort Myers | Florida | 33901 | — |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | — |
| Ocala Oncology Center PL DBA Florida Cancer Affiliates - Ocala | Ocala | Florida | 34474 | — |
| Florida Cancer Specialists North | St. Petersburg | Florida | 33705 | — |
| Kaiser Permanente | Honolulu | Hawaii | 96814 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Edward H. Kaplan MD & Associates | Skokie | Illinois | 60076 | — |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Cancer & Hematology Centers of Western Michigan - Lemmen-Holton Cancer Pavilion | Grand Rapids | Michigan | 49503 | — |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Nebraska Heme Onc | Lincoln | Nebraska | 68506 | — |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | — |
| The University of New Mexico Comprehensive Cancer Center | Albuquerque | New Mexico | 87131 | — |
| Stephenson Cancer Center at OUHSC | Oklahoma City | Oklahoma | 73104 | — |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | — |
| Oncology Consultants | Houston | Texas | 77030 | — |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | — |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | — |
| Swedish Cancer Institute | Seattle | Washington | 98104 | — |
| University of Wisconsin | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 45 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04082364, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 8, 2025 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04082364 live on ClinicalTrials.gov.