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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: Completed Phase 2 study, sponsored by MacroGenics.
NCT04082364 is a Phase 2 study that has completed, run by MacroGenics. The registered enrollment target is 82 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Evaluation of adverse events and serious adverse events (Cohort A)
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 |
What the finished NCT04082364 record still lists
NCT04082364 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 5 interventions - of which Trastuzumab is the first listed.
NCT04082364 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04082364's enrollment target sits among peer trials
82 830th of 2000 higher than 1,167 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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