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NCT03126591 · ClinicalTrials.gov registry record · Phase 1
A Study of Olaratumab (LY3012207) Plus Pembrolizumab in Participants With Advanced or Metastatic Soft Tissue Sarcoma
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
NCT03126591: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT03126591 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 41 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03126591, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety of olaratumab plus pembrolizumab in participants with previously treated advanced or metastatic soft tissue sarcoma.
Primary Outcome
A DLT was defined as an adverse event (AE) during Cycle 1 that is possibly related to the study drug and fulfills any 1 of the following criteria using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0: * Grade ≥3 nonhematologic toxicity, with exceptions * Grade 4 anemia * Grade 4 neutropenia or leukopenia of \>5 days duration * Febrile neutropenia * Grade 3 thrombocytopenia with clinically significant bleeding or Grade 4 thrombocytopenia * Any other
Interventions
- DRUG Pembrolizumab (KEYTRUDA®)
- DRUG Olaratumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2017-07-03 |
| Est. Completion | 2023-02-21 |
| Phase | Phase 1 |
What the finished NCT03126591 record still lists
NCT03126591 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% lower).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab (KEYTRUDA®) is the first listed.
NCT03126591 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03126591 about?
NCT03126591 is a clinical study titled "A Study of Olaratumab (LY3012207) Plus Pembrolizumab in Participants With Advanced or Metastatic Soft Tissue Sarcoma". The purpose of this study is to evaluate the safety of olaratumab plus pembrolizumab in participants with previously treated advanced or metastatic soft tissue sarcoma.
What is the current status of trial NCT03126591?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2017-07-03. Estimated completion is 2023-02-21.
What interventions are being tested in trial NCT03126591?
The interventions under investigation include: Pembrolizumab (KEYTRUDA®) (DRUG), Olaratumab (DRUG).
Who is sponsoring clinical trial NCT03126591?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03126591's enrollment target sits among peer trials
41 1125th of 2000 higher than 871 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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