Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Vinblastine

Trabectedin

Antineoplastic Agents, Alkylating

Alkylating Agents

INT230-6 administered intratumorally. Participants will be dosed every 2 weeks (± 2 days) for up to a total of 5-cycles (e.g., Days 1, 15, 29, 43 and 57). Once the participant has completed the treatment phase, they will continue into a 22-month maintenance phase, where investigators may inject new lesions or previously injected lesions with up to 175 mL every 12 weeks (Q12W) ± 14 days. Dose volume in a session is dependent on the participants presenting tumor burden.

Participants in this arm may receive any of the following depending on Soft tissue sarcoma (STS) subtype and PI preference:

* Pazopanib: 800 mg PO every day until clinical deterioration
* Trabectedin: 1.5 mg/m2 body surface area as 24-hour IV infusion every 3 weeks until clinical deterioration
* Eribulin: Non- European Union (EU) sites: 1.4 mg/m2 eribulin mesylate body surface area IV on Days 1 and 8 every 3 weeks until clinical deterioration EU sites: 1.23 mg/m2 (free base) body surface area IV on Days 1 and 8 every 3 weeks until clinical deterioration

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

INT230-6

Eribulin

Pazopanib

Kimberly Guedes, RN, M.B.A

Lewis H Bender, MS, MA, MBA

Christian F. Meyer, MD, PhD, MS

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.

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

A Multicenter, Randomized, Phase 3 Study to Assess the Efficacy and Safety of INtratumorally Administered INT230-6 (SHAO, VINblastine, CIsplatin) Compared With US Standard of Care in Adults With Locally Recurrent, InoperaBLE, or Metastatic Soft Tissue Sarcomas (INVINCIBLE-3)

General Data Protection Regulation (GDPR) and HIPPA privacy laws will be followed for sharing of any data.

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.

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

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

Spots Global Cancer Trial Database for A Study to Investigate Efficacy & Safety of INT230-6 Compared to US Standard of Care in Adults With Soft Tissue Sarcomas (INVINCIBLE-3)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial