LINNOVATE: Lurbinectedin, Ipilimumab and Nivolumab for Soft Tissue Sarcoma

This study is testing a combination of three drugs: Lurbinectedin, Ipilimumab, and Nivolumab, for people with advanced soft tissue sarcoma. Researchers want to find the highest safe dose of Lurbinectedin when given with fixed doses of Ipilimumab and Nivolumab. To join, you must be at least 18 years old and have soft tissue sarcoma that has spread or cannot be removed by surgery. For the first part of the study, only people who have already received treatment will be included. The main goal is to find the maximum tolerated dose (MTD) of Lurbinectedin within 6 months. The current status of this study is unclear, and it plans to enroll 40 participants.

Study design
This is an open-label (meaning you and your doctors will know what treatment you are receiving), dose-seeking Phase 1/2 study. It will enroll 40 participants to find the safest dose of Lurbinectedin when combined with Ipilimumab and Nivolumab.
What's involved
You would receive Lurbinectedin, Ipilimumab, and Nivolumab intravenously (through a vein). Treatment may continue until your disease progresses, side effects become too severe, or for up to one year.
Compensation
Not stated in the trial record.
Follow-up
Participants in the dose escalation study may continue treatment for up to a maximum of one year. The maximum tolerated dose (MTD) is measured at 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05876715

LINNOVATE: Lurbinectedin, Ipilimumab and Nivolumab for Soft Tissue Sarcoma

Recruiting
PHASE1Ages 18–90InterventionalTreatment
ERLINDA M GORDON
~40 participants
Updated 2024-07-05 on ClinicalTrials.gov
What's tested:Lurbinectedin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose
Measured over 6 months
Advanced Soft-tissue Sarcoma
1 sites across 1 states
California1
  • Erlinda M Gordon, MD · PRINCIPAL_INVESTIGATOR · Sarcoma Oncology Research Center

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  • Maximum tolerated dose6 months

    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.