Trial intelligence / Profile preview

ATRA and Cemiplimab in Advanced Leiomyosarcoma

NCT06528769Phase 2

Key facts

Status: Recruiting
Start: Sep 2025
Primary completion: Dec 2027
Countries: 1
Modality: Immune Checkpoint Inhibitors, Antibody Conjugates, Small Molecules

Drugs: tretinoincemiplimab
Conditions: leiomyosarcoma (LMS)

Overview

Phase 2, open-label, single-arm trial of tretinoin and cemiplimab in leiomyosarcoma (LMS). Primary endpoint: Overall Response Rate up to 24 months. Started Sep 2025; status: recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Treatment (ATRA and Cemiplimab)
ATRA + Cemiplimab for 3 cycles, followed by Cemiplimab monotherapy.

Who it enrols

Adults with metastatic or locally advanced unresectable leiomyosarcoma who have progressed on standard-of-care chemotherapy, with measurable disease and adequate organ function.

Endpoints

Primary

Overall Response RateUp to 24 months

Secondary

Progression-free survivalUp to 24 months
Disease control rateUp to 24 months
Overall survivalUp to 24 months
Dose limiting toxicityUp to 2 years
Incidence of adverse eventsUp to 2 years

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