A Study of Immunotherapy Treatment in People With Sarcoma

Sarcoma Clinical Trial

Official title:

An Observational Study of Sarcoma Patients Treated With Immune Checkpoint Blockade-based Therapy at Memorial Sloan Kettering Cancer Center

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06113315
• Other study ID #: 23-254
• Status: Enrolling by invitation
• Start date: October 27, 2023
• Est. completion date: October 2028

Study information

• Verified date: October 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to collect information from participants' medical records to improve our knowledge about immunotherapy use and how effective it is as a treatment for people with sarcoma. Immunotherapy drugs boost the immune system's ability to fight cancer by blocking proteins that act as a "brake" on the immune system. Blocking these proteins is like releasing the brakes, so that the immune system can target cancer cells and destroy them. This action is sometimes described as "immune checkpoint blockade.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: October 2028
• Est. primary completion date: October 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Participants must have a histologic diagnosis of sarcoma confirmed by an MSK pathologist.
• Any prospectively identified patient being treated or to be treated with an immune checkpoint inhibitor, such as anti-PD-1, anti-PD-L1, anti-CTLA-4, or anti-LAG3 inhibitor, either as monotherapy or in combination with additional systemic therapy o Novel immune checkpoints inhibitors that are developed after submission of this protocol will also be included) Please Note: there is no age requirement. Patients of all ages are eligible to enroll

Exclusion Criteria:

• Patient unwilling to consent to collection of historical and longitudinal clinicopathologic data in the patient medical record from baseline (the period prior to ICB initiation), during, and after ICB treatment

Related Conditions & MeSH terms

• Sarcoma

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Cancer Center Suffolk- Commack (All Protocol Activities)	Commack	New York
United States	Memorial Sloan Kettering Westchester (All Protocol Activities)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (All Protocol Activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (All Protocol Activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau (All Protocol Activities)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To collect real-world observational clinical, radiographic, and molecular features	of sarcoma patients treated with ICB, as documented in medical records, to improve knowledge about immunotherapy use and efficacy in sarcoma. Descriptive statistics will be used to summarize the overall study population and their clinicopathologic characteristics using median, interquartile range and range, frequency and/or percentages.	up to 5 years

External Links

•   Memorial Sloan Kettering Cancer Center