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

Conditions

• Sarcoma,Soft Tissue

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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.

Key Dates

First listed

Feb 16, 2024

Start date

Jun 28, 2024

Status verified

Aug 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

333 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: INT230-6 Monotherapy
  INT230-6 administered intratumorally. Participants will be dosed every 2 weeks (± 2 days) for up to a total of 5 treatment sessions (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 of INT230-6 every 12 weeks (Q12W) ± 14 days. Dose volume in a session is dependent on the participants presenting tumor burden.
• Active Comparator: US Standard of Care
  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 or disease progression * Trabectedin: 1.5 mg/m2 body surface area as 24-hour IV infusion every 3 weeks until clinical deterioration or disease progression * 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 or disease progression EU sites: 1.23 mg/m2 (free base) body surface area IV on Days 1 and 8 every 3 weeks until clinical deterioration or disease progression

Primary Outcome Measure

Overall Survival (OS) [ 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. ]

Central Contacts

• Kimberly Guedes, RN, M.B.A
  (203) 293-4224
  [email protected]
• Lewis H Bender, MS, MA, MBA
  (203) 221-7377
  [email protected]

Locations (10)

Find similar trials in Los Angeles, CA

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