LINNOVATE: Lurbinectedin, Ipilimumab and Nivolumab for Soft Tissue Sarcoma

ConditionAdvanced Soft-tissue Sarcoma

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18-90

SponsorERLINDA M GORDON

About this trial

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 criteria

Qualifiers

Male or Female ≥ 18 years of age

Pathologically confirmed diagnosis of locally advanced unresectable or metastatic soft tissue sarcoma

For the Phase 1 Part of Study, only previously treated participants will be enrolled. For the Phase 2 Part of Study, previously untreated participants will be enrolled.

Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the principal investigator's IRB/Ethics Committee

Disqualifiers

Subjects with untreated CNS metastases. Subjects are eligible if CNS metastases have been adequately treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to treatment initiation. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of <10 mg daily prednisone (or equivalent) for at least 2 weeks prior to treatment initiation.

Subjects with carcinomatous meningitis

Anticancer treatment with radiation therapy, targeted therapy or other antitumor treatment within 2 weeks prior to study entry. Anticancer treatment with chemotherapy within 21 days prior to study entry.

Subjects who participated in an investigational drug or device study within 14 days prior to study entry

Trial design

Treatments tested in this trial

Lurbinectedin

Treatment groups

40 Participants

are divided into 1 treatment group

Sponsors and collaborators

ERLINDA M GORDON

Lead sponsor

Sarcoma Oncology Research Center, LLC

Sponsor institution

Source ClinicalTrials.gov