Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06528769 · ClinicalTrials.gov registry record · Phase 2
Study of All-Trans Retinoic Acid (ATRA) and Cemiplimab in Patients With Advanced Leiomyosarcoma
A Phase 2 study of Sarcoma and Leiomyosarcoma, sponsored by Gabriel Tino.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT06528769 is a Phase 2 study of Sarcoma and Leiomyosarcoma that is actively recruiting participants, run by Gabriel Tino. The registered enrollment target is 16 participants, below the 921-participant average among 122 other Sarcoma trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06528769, a Phase 2 study of Sarcoma and Leiomyosarcoma, is actively recruiting participants, sponsored by Gabriel Tino.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
A phase 2 study assessing the efficacy of all-trans retinoic acid (ATRA) and Cemiplimab in patients with metastatic/locally advanced - unresectable leiomyosarcoma (LMS) who have progressed standard-of-care therapy. Patients will be enrolled in cohorts according to a Bayesian Optimal Phase II design (BOP2). Study treatment will consist of ATRA at a starting dose of 150 mg/m2/day for 3 days orally prior to each cycle of Cemiplimab 350 mg IV q3 weeks for three cycles and then Cemiplimab monotherapy until the progress of disease or unacceptable toxicities develops.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Cemiplimab
- DRUG all-trans retinoic acid
- PROCEDURE Magnetic resonance imaging
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2025-09-10 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06528769
The ClinicalTrials.gov registry entry for NCT06528769 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 921-participant average among 122 other Sarcoma trials with a reported enrollment target (98% lower). The listed sponsor is Gabriel Tino, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Sarcoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06528769 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT06528769 about?
NCT06528769 is a clinical study titled "Study of All-Trans Retinoic Acid (ATRA) and Cemiplimab in Patients With Advanced Leiomyosarcoma". A phase 2 study assessing the efficacy of all-trans retinoic acid (ATRA) and Cemiplimab in patients with metastatic/locally advanced - unresectable leiomyosarcoma (LMS) who have progressed standard-of-care therapy. Patients will be enrolled in cohorts according to a Bayesian Optimal Phase II design ...
What is the current status of trial NCT06528769?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2025-09-10. Estimated completion is 2027-12-31.
What conditions does trial NCT06528769 study?
This clinical trial studies the following conditions: Sarcoma, Leiomyosarcoma.
What interventions are being tested in trial NCT06528769?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Cemiplimab (DRUG), all-trans retinoic acid (DRUG), Magnetic resonance imaging (PROCEDURE).
Who is sponsoring clinical trial NCT06528769?
This trial is sponsored by Gabriel Tino, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06528769 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study of Cabozantinib as a Maintenance Agent to Prevent Progression or Recurrence in High-Risk Pediatric Solid Tumors
RECRUITING · Phase 2
-
A Study of AdAPT-001 in Subjects With Sarcoma and Refractory Solid Tumors
RECRUITING · Phase 2
-
Repurposing Riluzole for Cancer-Related Cognitive Impairment: A Pilot Trial
RECRUITING · Phase 2
-
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
RECRUITING · Phase 2
-
Fluorescent Intra-operative Tumor Margin Examination
RECRUITING · Phase 2
-
Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot Trial
RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.