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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Lurbinectedin

    Drug

    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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Phase 1/2 study using lurbinectedin, ipilimumab and nivolumab for advanced soft tissue sarcomaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum tolerated dose

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.

Time frame
6 months

Secondary outcomes

1

Objective response rate

The number of patients achieving a complete response and partial response divided by the number of patients who completed at least one treatment cycle and had a follow up computerized tomography (CT) scan

Time frame
24 months
2

Progression free survival at 6 months

The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.

Time frame
12 months
3

Overall survival

The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. I

Time frame
36 months
4

Correlation of response with circulating tumor DNA

Correlation of response with circulating tumor DNA

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ERLINDA M GORDON

Lead sponsor

Sarcoma Oncology Research Center, LLC

Sponsor institution

Source ClinicalTrials.gov
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