LINNOVATE: Lurbinectedin, Ipilimumab and Nivolumab for Soft Tissue Sarcoma

Conditions

• Advanced Soft-tissue Sarcoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Jun 7, 2023

Status verified

Jul 2024

Primary completion

Jun 30, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

40 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Phase 1/2 study using lurbinectedin, ipilimumab and nivolumab for advanced soft tissue sarcoma
  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. I. Dose Escalation Phase 1 of Study: The study will employ the standard "cohort of three" design (Storer, 1989). II.Phase 2 of Study: Following completion of dose escalation, an additional 28-34 previously untreated participants will receive LURBINECTEDIN at the MTD and fixed doses of IPILIMUMAB and NIVOLUMAB to assess overall safety and potential efficacy in a larger number of participants.

Primary Outcome Measure

Maximum tolerated dose [ Time Frame: 6 months ]

Central Contacts

• Erlinda M Gordon, MD
  310-552-9999
  [email protected]
• Victoria Chua-Alcala, MD
  310-552-9999
  [email protected]

Locations (1)

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