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NCT04082364 · ClinicalTrials.gov registry record · Phase 2
Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer
A Phase 2 study, sponsored by MacroGenics.
- Completed
- Registry status
- Phase 2
- Development phase
- 82
- Enrollment target
NCT04082364 is a Phase 2 study that has completed, run by MacroGenics. The registered enrollment target is 82 participants.
The verdict
NCT04082364, a Phase 2 study, has completed, sponsored by MacroGenics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 82 participants
- Enrollment target
Study 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 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.
Interventions
- BIOLOGICAL Trastuzumab
- BIOLOGICAL Retifanlimab
- OTHER Chemotherapy
- BIOLOGICAL margetuximab
- BIOLOGICAL Tebotelimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2019-09-30 |
| Est. Completion | 2025-03-25 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04082364
The ClinicalTrials.gov registry entry for NCT04082364 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MacroGenics, which has 36 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Trastuzumab is the first listed.
NCT04082364 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04082364 about?
NCT04082364 is a clinical study titled "Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer". 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...
What is the current status of trial NCT04082364?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2019-09-30. Estimated completion is 2025-03-25.
What interventions are being tested in trial NCT04082364?
The interventions under investigation include: Trastuzumab (BIOLOGICAL), Retifanlimab (BIOLOGICAL), Chemotherapy (OTHER), margetuximab (BIOLOGICAL), Tebotelimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04082364?
This trial is sponsored by MacroGenics, which has 36 total clinical trials registered on ClinicalTrials.gov.
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