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NCT05876715 · ClinicalTrials.gov registry record · Phase 1
LINNOVATE: Lurbinectedin, Ipilimumab and Nivolumab for Soft Tissue Sarcoma
A Phase 1 study of Advanced Soft Tissue Sarcoma, sponsored by Erlinda M Gordon.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05876715: Recruiting Phase 1 study of Advanced Soft Tissue Sarcoma, sponsored by Erlinda M Gordon.
NCT05876715 is a Phase 1 study of Advanced Soft Tissue Sarcoma that is actively recruiting participants, run by Erlinda M Gordon. The registered enrollment target is 40 participants, below the 85-participant average among 6 other Advanced Soft Tissue Sarcoma trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05876715, a Phase 1 study of Advanced Soft Tissue Sarcoma, is actively recruiting participants, sponsored by Erlinda M Gordon.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open label, dose-seeking phase 1/2 study using escalating doses of LURBINECTEDIN administered intravenously with fixed doses of IPILIMUMAB and NIVOLUMAB administered intravenously.
Primary Outcome
The maximum tolerated dose (MTD) is defined as the highest safely tolerated dose of lurbinectedin, where not more than one participant experienced a dose limiting toxicity (DLT), with the next higher dose level having at least two participants who experienced DLT.
Conditions Studied
Interventions
- DRUG Lurbinectedin
Study Locations (1)
California
- Sarcoma Oncology Research Center - Santa Monica
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-06-07 |
| Est. Completion | 2026-09-30 |
| Phase | Phase 1 |
What NCT05876715 shows while recruiting
NCT05876715 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 85-participant average among 6 other Advanced Soft Tissue Sarcoma trials with a reported enrollment target (53% lower).
The record links to 1 condition, with Advanced Soft Tissue Sarcoma appearing as the primary indexed condition, and to 1 intervention - of which Lurbinectedin is the first listed.
NCT05876715 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05876715 about?
NCT05876715 is a clinical study titled "LINNOVATE: Lurbinectedin, Ipilimumab and Nivolumab for Soft Tissue Sarcoma". This is an open label, dose-seeking phase 1/2 study using escalating doses of LURBINECTEDIN administered intravenously with fixed doses of IPILIMUMAB and NIVOLUMAB administered intravenously.
What is the current status of trial NCT05876715?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2023-06-07. Estimated completion is 2026-09-30.
What conditions does trial NCT05876715 study?
This clinical trial studies the following conditions: Advanced Soft Tissue Sarcoma.
What interventions are being tested in trial NCT05876715?
The interventions under investigation include: Lurbinectedin (DRUG).
Who is sponsoring clinical trial NCT05876715?
This trial is sponsored by Erlinda M Gordon, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05876715 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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