RecruitingPhase 1Phase 2NCT05876715

LINNOVATE: Lurbinectedin, Ipilimumab and Nivolumab for Soft Tissue Sarcoma

LINNOVATE: A Phase 1/2 Study of Safety/Efficacy Using LURBINECTEDIN, Combined With IPILIMUMAB, and NIVOLUMAB for Advanced Soft Tissue Sarcomas


Sponsor

ERLINDA M GORDON

Enrollment

40 participants

Start Date

Jun 7, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of three drugs — lurbinectedin, ipilimumab (Yervoy), and nivolumab (Opdivo) — in patients with advanced soft tissue sarcoma (a cancer of the connective tissues like muscle, fat, or tendons). The Phase 1 part looks at safety in previously treated patients; Phase 2 looks at effectiveness in newly diagnosed patients. **You may be eligible if...** - You are 18 or older with confirmed advanced or metastatic soft tissue sarcoma - Phase 1: You have received prior treatment; Phase 2: You have not received prior treatment - You have at least one measurable tumor on scans - Your physical performance is good (ECOG 0–1) - Your liver, kidney, and blood counts are within acceptable ranges **You may NOT be eligible if...** - You have untreated brain metastases or cancer in the fluid around the brain - You have an active autoimmune disease - You have had prior immunotherapy with checkpoint inhibitors (anti-CTLA-4 or anti-PD-1) - You have inflammatory bowel disease, HIV, hepatitis B or C - You are pregnant or breastfeeding - You have significant heart disease - You have a history of heavy alcohol abuse Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLurbinectedin

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.


Locations(1)

Sarcoma Oncology Research Center

Santa Monica, California, United States

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NCT05876715


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