Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-01-22 @ 1:49 PM
Study NCT ID:
NCT06528769
Status:
RECRUITING
Last Update Posted:
2025-09-30
First Post:
2024-07-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of All-Trans Retinoic Acid (ATRA) and Cemiplimab in Patients With Advanced Leiomyosarcoma
Sponsor:
Gabriel Tinoco
Organization:
Study Overview
Official Title:
A Phase II Study of All-Trans Retinoic Acid (ATRA) and Cemiplimab in Patients With Advanced Leiomyosarcoma
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
PRIMARY OBJECTIVES
I. To determine the efficacy of the combination of ATRA and Cemiplimab in patients with metastatic/locally advanced -unresectable LMS by assessing objective response (ORR), Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and immune mediated Response Evaluation Criteria for Solid Tumors (iRECIST).
SECONDARY OBJECTIVES
I. To study the efficacy of the combination of ATRA and Cemiplimab in patients with advanced LMS, including progression-free survival (PFS), disease control rate (DCR), and overall survival (OS) based on modified RECIST version 1.1 and iRECIST.
II. To determine the safety and tolerability of the combination of ATRA and Cemiplimab in patients with metastatic/locally advanced -unresectable LMS based upon the Common Terminology Criteria for Adverse Events (CTCAE) version 5 criteria.
EXPLORATORY OBJECTIVES
I. To study the effect of ATRA on the levels of myeloid-derived suppressor cells (MDSCs) in the peripheral blood of study patients
OUTLINE:
Patients receive ATRA orally (PO) on days -2 to 0 followed by cemiplimab intravenously (IV) on day 1 of each cycle. ATRA treatment is given for 3 cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo urine sample collection during screening, and computed tomography (CT) scan/magnetic resonance imaging (MRI) and blood sample collection throughout the study.
After completion of study treatment, patients are followed up every 12-16 weeks.
.
I. To determine the efficacy of the combination of ATRA and Cemiplimab in patients with metastatic/locally advanced -unresectable LMS by assessing objective response (ORR), Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and immune mediated Response Evaluation Criteria for Solid Tumors (iRECIST).
SECONDARY OBJECTIVES
I. To study the efficacy of the combination of ATRA and Cemiplimab in patients with advanced LMS, including progression-free survival (PFS), disease control rate (DCR), and overall survival (OS) based on modified RECIST version 1.1 and iRECIST.
II. To determine the safety and tolerability of the combination of ATRA and Cemiplimab in patients with metastatic/locally advanced -unresectable LMS based upon the Common Terminology Criteria for Adverse Events (CTCAE) version 5 criteria.
EXPLORATORY OBJECTIVES
I. To study the effect of ATRA on the levels of myeloid-derived suppressor cells (MDSCs) in the peripheral blood of study patients
OUTLINE:
Patients receive ATRA orally (PO) on days -2 to 0 followed by cemiplimab intravenously (IV) on day 1 of each cycle. ATRA treatment is given for 3 cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo urine sample collection during screening, and computed tomography (CT) scan/magnetic resonance imaging (MRI) and blood sample collection throughout the study.
After completion of study treatment, patients are followed up every 12-16 weeks.
.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2024-10630 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |