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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: Recruiting Phase 1 study of Metastatic Soft Tissue Sarcoma and Advanced Soft Tissue Sarcoma, sponsored by Sarcoma Oncology Research Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Dose escalation study, determination of maximum tolerated dose (MTD) in previoiusly treated patients with soft tissue sarcoma followed by expansion to previously untreated patients with advanced STS
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 |
What NCT03138161 shows while recruiting
NCT03138161 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 119-participant average among 12 other Metastatic Soft Tissue Sarcoma trials with a reported enrollment target (110% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03138161's enrollment target sits among peer trials
250 3rd of 12 higher than 10 of 12 other Metastatic Soft Tissue Sarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Soft Tissue Sarcoma 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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