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NCT02475213 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab or MGA012 in Refractory Cancer
A Phase 1 study, sponsored by MacroGenics.
- Completed
- Registry status
- Phase 1
- Development phase
- 146
- Enrollment target
NCT02475213: Completed Phase 1 study, sponsored by MacroGenics.
NCT02475213 is a Phase 1 study that has completed, run by MacroGenics. The registered enrollment target is 146 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (143% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02475213, a Phase 1 study, has completed, sponsored by MacroGenics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 146 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety of enoblituzumab (MGA271) in combination with Keytruda (pembrolizumab) when given to patients with B7-H3-expressing melanoma, squamous cell carcinoma of the head and neck (SCCHN), non small cell lung cancer (NSCLC), Urothelial Cancer and other B7-H3 expressing cancers. The study will also evaluate what is the highest dose of enoblituzumab that can be given safely when given with pembrolizumab. Assessments will also be done to see how the drug acts in the body (pharmacokinetics (PK), pharmacodynamics) and to evaluate potential anti-tumor activity of MGA271 in combination with pembrolizumab. Safety and efficacy of enoblituzumab in combination with MGA012 (anti-PD-1 monoclonal antibody; also known as INCMGA00012) will also be evaluated.
Primary Outcome
Dose-limiting toxicities are severe side effects related to study treatment that may cause dose interruptions, dose reductions, or withdrawal of treatment.
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL Enoblituzumab Schedule 1
- BIOLOGICAL Enoblituzumab Schedule 2
- BIOLOGICAL retifanlimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2015-07 |
| Est. Completion | 2021-08-18 |
| Phase | Phase 1 |
What the finished NCT02475213 record still lists
NCT02475213 is an interventional study that assigns participants to a tested intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (143% higher).
The record links to 0 conditions, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT02475213 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02475213 about?
NCT02475213 is a clinical study titled "Safety Study of Enoblituzumab (MGA271) in Combination With Pembrolizumab or MGA012 in Refractory Cancer". The purpose of this study is to evaluate the safety of enoblituzumab (MGA271) in combination with Keytruda (pembrolizumab) when given to patients with B7-H3-expressing melanoma, squamous cell carcinoma of the head and neck (SCCHN), non small cell lung cancer (NSCLC), Urothelial Cancer and other B7-H...
What is the current status of trial NCT02475213?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 146 participants. The study started on 2015-07. Estimated completion is 2021-08-18.
What interventions are being tested in trial NCT02475213?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Enoblituzumab Schedule 1 (BIOLOGICAL), Enoblituzumab Schedule 2 (BIOLOGICAL), retifanlimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02475213?
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 NCT02475213's enrollment target sits among peer trials
146 391st of 2000 higher than 1,610 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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