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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 is a Phase 1 study that has completed, run by MacroGenics. The registered enrollment target is 146 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02475213
The ClinicalTrials.gov registry entry for NCT02475213 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 146 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 4 interventions - of which Pembrolizumab is the first listed.
NCT02475213 reports 0 study locations.
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.
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