Clinical trial NCT06113315: A Study of Immunotherapy Treatment in People With Sarcoma
Official title: An Observational Study of Sarcoma Patients Treated With Immune Checkpoint Blockade-based Therapy at Memorial Sloan Kettering Cancer Center
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Sarcoma
Keywords: Immunotherapy
Immune Blockade-Based Therapy
23-254
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with sarcoma treated with immune checkpoint blockade (ICB; anti-PD-1, PD-L1, and/or CTLA-4) based therapy at Memorial Sloan Kettering Cancer Center (MSK).

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: To collect real-world observational clinical, radiographic, and molecular features
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (All Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (All Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center Suffolk- Commack (All Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (All Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Evan Rosenbaum, MD
role: PRINCIPAL_INVESTIGATOR
References: