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NCT03558139 · ClinicalTrials.gov registry record · Phase 1
Study of Magrolimab (Hu5F9-G4) in Combination With Avelumab in Solid Tumor Participants and Checkpoint-Inhibitor-Naive Ovarian Cancer Participants Who Progress Within 6 Months of Prior Platinum Chemotherapy
A Phase 1 study of Ovarian Cancer, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
- 6
- Study locations
NCT03558139: Completed Phase 1 study of Ovarian Cancer, sponsored by Gilead Sciences.
NCT03558139 is a Phase 1 study of Ovarian Cancer that has completed, run by Gilead Sciences. The registered enrollment target is 34 participants, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (95% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03558139, a Phase 1 study of Ovarian Cancer, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
- 6
- Study locations
Study Summary
The primary objectives of this study are to investigate the safety and tolerability of magrolimab in combination with avelumab in participants with advanced solid tumors and to confirm the safety and tolerability of this combination and evaluate the anti-tumor activity in participants with checkpoint inhibitor-naive ovarian cancer, fallopian tube cancer, and primary peritoneal carcinoma who have previously progressed within 1-6 months of receiving platinum chemotherapy.
Primary Outcome
A DLT was defined as a ≥ Grade 3 AE that was assessed as related to either magrolimab or avelumab that occurred during the 5-week DLT assessment period with protocol-defined allowed exceptions. Any treatment-emergent adverse event (TEAE) that was, in the opinion of the Clinical Trial Steering Committee, of potential clinical significance such that further dosing exposed participants to unacceptable risk, was considered a DLT.
Conditions Studied
Interventions
- DRUG Avelumab
- DRUG Magrolimab
Study Locations (6)
Texas
- University of Texas Southwestern Medical Center - Dallas
- South Texas Accelerated Research Therapeutics, LLC - San Antonio
Illinois
- University of Chicago - Chicago
Michigan
- START Midwest - Grand Rapids
Oklahoma
- Oklahoma University Health Sciences Center - Oklahoma City
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2018-05-23 |
| Est. Completion | 2020-12-03 |
| Phase | Phase 1 |
What the finished NCT03558139 record still lists
NCT03558139 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Ovarian Cancer appearing as the primary indexed condition, and to 2 interventions - of which Avelumab is the first listed.
NCT03558139 lists 6 locations in 5 states (Texas, Illinois, Michigan).
Frequently Asked Questions
What is clinical trial NCT03558139 about?
NCT03558139 is a clinical study titled "Study of Magrolimab (Hu5F9-G4) in Combination With Avelumab in Solid Tumor Participants and Checkpoint-Inhibitor-Naive Ovarian Cancer Participants Who Progress Within 6 Months of Prior Platinum Chemotherapy". The primary objectives of this study are to investigate the safety and tolerability of magrolimab in combination with avelumab in participants with advanced solid tumors and to confirm the safety and tolerability of this combination and evaluate the anti-tumor activity in participants with checkpoin...
What is the current status of trial NCT03558139?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2018-05-23. Estimated completion is 2020-12-03.
What conditions does trial NCT03558139 study?
This clinical trial studies the following conditions: Ovarian Cancer.
What interventions are being tested in trial NCT03558139?
The interventions under investigation include: Avelumab (DRUG), Magrolimab (DRUG).
Who is sponsoring clinical trial NCT03558139?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03558139 being conducted?
This trial has 6 study locations across Illinois, Michigan, Oklahoma, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03558139's enrollment target sits among peer trials
34 243rd of 322 higher than 78 of 322 other Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Cancer 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.
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