Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528769
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
A Phase II Study of All-Trans Retinoic Acid ATRA and Cemiplimab in Patients With Advanced Leiomyosarcoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Study of All-Trans Retinoic Acid ATRA and Cemiplimab in Patients With Advanced Leiomyosarcoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 metastaticlocally 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 mgm2day 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 mgm2day 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 metastaticlocally advanced -unresectable LMS by assessing objective response ORR based on modified RECIST version 11 and 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 11 and iRECIST
II To determine the safety and tolerability of the combination of ATRA and Cemiplimab in patients with metastaticlocally 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
I To determine the efficacy of the combination of ATRA and Cemiplimab in patients with metastaticlocally advanced -unresectable LMS by assessing objective response ORR based on modified RECIST version 11 and 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 11 and iRECIST
II To determine the safety and tolerability of the combination of ATRA and Cemiplimab in patients with metastaticlocally 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None