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: Recruiting Phase 2 study of Sarcoma and Leiomyosarcoma, sponsored by Gabriel Tino.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Overall response rate (ORR) will be calculated based on modified RECIST version 1.1 and iRECIST with a 95% confidence interval (CI).
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 |
What NCT06528769 shows while recruiting
NCT06528769 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 921-participant average among 122 other Sarcoma trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Where NCT06528769's enrollment target sits among peer trials
16 106th of 122 higher than 15 of 122 other Sarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sarcoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02422641 · 16 participants · Phase 2
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
- NCT02851758 · 16 participants · NA
Transplantation of Autologously Derived Mitochondria Following Ischemia
- NCT03291028 · 16 participants
Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma
- NCT03425526 · 16 participants · Phase 1
Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI
- NCT06358040 · started 2026-10 · NA
Opioid Dispenser for Microdiscectomy/Laminectomy