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NCT03138161 · ClinicalTrials.gov registry record · Phase 1
SAINT:Trabectedin, Ipilimumab and Nivolumab for Previously Treated Advanced Soft Tissue Sarcoma
A Phase 1 study of Metastatic Soft Tissue Sarcoma and Advanced Soft Tissue Sarcoma, sponsored by Sarcoma Oncology Research Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 250
- Enrollment target
- 1
- Study location
NCT03138161 is a Phase 1 study of Metastatic Soft Tissue Sarcoma and Advanced Soft Tissue Sarcoma that is actively recruiting participants, run by Sarcoma Oncology Research Center. The registered enrollment target is 250 participants, above the 119-participant average among 12 other Metastatic Soft Tissue Sarcoma trials with a reported enrollment target (110% higher). The trial reports 1 study location across 1 state.
The verdict
NCT03138161, a Phase 1 study of Metastatic Soft Tissue Sarcoma and Advanced Soft Tissue Sarcoma, is actively recruiting participants, sponsored by Sarcoma Oncology Research Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 250 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open label, dose-seeking phase 1/2 study using escalating doses of TRABECTEDIN given intravenously with defined doses of IPILIMUMAB and NIVOLUMAB based on preliminary results of the Checkmate 012 trial for NSCLC (Hellman et al., 2016). For the Phase 1 Part of Study, only previously treated patients will be enrolled. For the Phase 2 Part of Study, previously treated patients will be enrolled.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG Trabectedin
Study Locations (1)
California
- Sarcoma Oncology Research Center - Santa Monica
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2017-04-13 |
| Est. Completion | 2031-07-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03138161
The ClinicalTrials.gov registry entry for NCT03138161 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 119-participant average among 12 other Metastatic Soft Tissue Sarcoma trials with a reported enrollment target (110% higher). The listed sponsor is Sarcoma Oncology Research Center, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Metastatic Soft Tissue Sarcoma appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT03138161 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03138161 about?
NCT03138161 is a clinical study titled "SAINT:Trabectedin, Ipilimumab and Nivolumab for Previously Treated Advanced Soft Tissue Sarcoma". This is an open label, dose-seeking phase 1/2 study using escalating doses of TRABECTEDIN given intravenously with defined doses of IPILIMUMAB and NIVOLUMAB based on preliminary results of the Checkmate 012 trial for NSCLC (Hellman et al., 2016). For the Phase 1 Part of Study, only previously treate...
What is the current status of trial NCT03138161?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 250 participants. The study started on 2017-04-13. Estimated completion is 2031-07-31.
What conditions does trial NCT03138161 study?
This clinical trial studies the following conditions: Metastatic Soft Tissue Sarcoma, Advanced Soft Tissue Sarcoma.
What interventions are being tested in trial NCT03138161?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), Trabectedin (DRUG).
Who is sponsoring clinical trial NCT03138161?
This trial is sponsored by Sarcoma Oncology Research Center, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03138161 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.