Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-28 @ 8:20 PM
Study NCT ID:
NCT05017103
Status:
TERMINATED
Last Update Posted:
2024-12-11
First Post:
2021-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sintilimab for the Treatment of Locally Advanced, Metastatic, Recurrent, or Unresectable Undifferentiated Pleomorphic Sarcoma, SiARa Cancer Study
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Phase II Clinical Trial Evaluating the Efficacy and Safety of Sintilimab for Advanced Rare Cancers (SiARa Cancer Study) - Undifferentiated Pleomorphic Sarcoma (SiARa-UPS)
Status:
TERMINATED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The drug sponsor stopped supporting study.
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial investigates the effects of sintilimab in treating patients with undifferentiated pleomorphic sarcoma that has spread to nearby tissue or lymph nodes (locally advanced), spread to other places in the body (metastatic), come back (recurrent), or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as sintilimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Detailed Description:
PRIMARY OBJECTIVE:
I. To evaluate the efficacy of sintilimab in subjects with undifferentiated pleomorphic sarcoma (UPS) (overall response rate \[ORR\] at 12 weeks \[12W\] by Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1).
SECONDARY OBJECTIVE:
I. To evaluate the ORR (RECIST 1.1) and disease control rate (DCR), PFS, overall survival (OS), safety and duration of response (DOR) of sintilimab in subjects with UPS.
EXPLORATORY OBJECTIVES:
I. To evaluate the correlation between biomarkers in tumor tissue and efficacy, including but not restricted to PD-L1 expression level, tertiary lymphoid structures (TLS) transcriptome sequencing, single-cell sequencing, and multicolor immunohistochemistry (IHC) analyses.
II. To evaluate the correlation between biomarkers in peripheral blood and efficacy, including but not restricted to soluble PD-L1, circulating tumor deoxyribonucleic acid (DNA) (ctDNA), identification/quantification of immunologic changes, and cytokine analyses.
OUTLINE:
Patients receive sintilimab intravenously (IV) over 30-60 minutes on day 1. Cycles repeat every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 60 days for 3 years.
I. To evaluate the efficacy of sintilimab in subjects with undifferentiated pleomorphic sarcoma (UPS) (overall response rate \[ORR\] at 12 weeks \[12W\] by Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1).
SECONDARY OBJECTIVE:
I. To evaluate the ORR (RECIST 1.1) and disease control rate (DCR), PFS, overall survival (OS), safety and duration of response (DOR) of sintilimab in subjects with UPS.
EXPLORATORY OBJECTIVES:
I. To evaluate the correlation between biomarkers in tumor tissue and efficacy, including but not restricted to PD-L1 expression level, tertiary lymphoid structures (TLS) transcriptome sequencing, single-cell sequencing, and multicolor immunohistochemistry (IHC) analyses.
II. To evaluate the correlation between biomarkers in peripheral blood and efficacy, including but not restricted to soluble PD-L1, circulating tumor deoxyribonucleic acid (DNA) (ctDNA), identification/quantification of immunologic changes, and cytokine analyses.
OUTLINE:
Patients receive sintilimab intravenously (IV) over 30-60 minutes on day 1. Cycles repeat every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 60 days for 3 years.
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?:
None
Is an FDA AA801 Violation?: