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A Study to Investigate Efficacy & Safety of Intratumoral INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3)

ConditionSarcoma,Soft Tissue
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorIntensity Therapeutics, Inc.

About this trial

To compare Overall Survival (OS) for INT230-6 vs United States (US) Standard of Care (SOC) in participants with unresectable or metastatic liposarcoma, undifferentiated pleomorphic sarcoma or leiomyosarcoma who have disease progression prior to study enrollment following no more than 2 standard therapies, which must have included an anthracycline-based regimen, unless contraindicated, and then a maximum of 1 additional regimen.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant is of any sex and must be ≥ 18 years old and provide written informed consent to participate in the study.

Histologically proven, unresectable, locally advanced, or metastatic Soft Tissue Sarcoma (STS) only of the following subtypes: liposarcoma (dedifferentiated, myxoid, round cell or pleomorphic), leiomyosarcoma, and undifferentiated pleomorphic sarcoma. Participant must have a pathology report indicating the diagnosis of their STS.

Participant must have received at least 1 line of therapy for a STS and must have progressed following anthracycline-based or alternative standard therapies, except if medically contraindicated or refused by participant. Participant cannot have received more than 2 prior regiments for unresectable, locally advanced or metastatic STS.

Participant must have measurable disease per RECIST 1.1 criteria.

Disqualifiers

Adult participants who lack capacity to consent without a legally authorized representative will be excluded from this study.

Prior primary or metastatic brain or meningeal tumors unless clinically and radiographically stable as well as off-steroid therapy for at least 2 months.

History of severe hypersensitivity reactions to US SOC agents and vinblastine or cisplatin or other products of the same class and their excipients.

Histologically proven, unresectable, locally advanced or metastatic STS subtypes other than those specified, for example excluded subtypes include liposarcoma (well differentiated), desmoid or dermatofibrosarcoma protuberans.

Trial design

Design model

Parallel

Treatments tested in this trial

  • INT230-6

    Drug

    INT230-6 is a fixed combination of cisplatin, vinblastine and SHAO.

  • Eribulin

    Drug

    Eribulin IV

  • Trabectedin

    Drug

    Trabectedin infusion

  • Pazopanib

    Drug

    Pazopanib pill

Treatment groups

333 Participants
are divided into 2 treatment groups
Group A: INT230-6 MonotherapyExperimental treatment 1 intervention
Group B: US Standard of CareActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

To compare OS for INT230-6 vs US Standard of Care (SOC) in participants with unresectable or metastatic liposarcoma, undifferentiated pleomorphic sarcoma or leiomyosarcoma who have disease progression prior to study enrollment following no more than 2 standard therapies, which must have included an anthracycline-based regimen, unless contraindicated, and then a maximum of 1 additional regimen.

Time frame
From date of randomization until the documented date of death from any cause for a period of up to 2 years, unless superiority is demonstrated sooner or 80% of deaths during the study period.

Secondary outcomes

1

Overall Survival (OS) For INT230-6 Compared to OS for Standard of Care (SOC) for Participants with leiomyosarcoma

To compare OS for INT230-6 vs US SOC in participants with leiomyosarcoma

Time frame
From date of randomization until the documented date of death from any cause for a period of up to 2 years, unless superiority is demonstrated sooner or 80% of deaths during the study period.
2

Overall Survival (OS) For INT230-6 Compared to OS for Standard of Care (SOC) for Participants with liposarcoma

To compare OS for INT230-6 vs US SOC in participants with liposarcoma

Time frame
From date of randomization until the documented date of death from any cause for a period of up to 2 years, unless superiority is demonstrated sooner or 80% of deaths during the study period.

Other outcomes

Sponsors and contacts

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

Intensity Therapeutics, Inc.

Lead sponsor

Premier Research

Collaborator

Source ClinicalTrials.gov
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