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A Study of Immunotherapy Treatment in People With Sarcoma

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06113315
Collaborator
(none)
250
Enrollment
7
Locations
59.2
Anticipated Duration (Months)
35.7
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    An Observational Study of Sarcoma Patients Treated With Immune Checkpoint Blockade-based Therapy at Memorial Sloan Kettering Cancer Center
    Actual Study Start Date :
    Oct 27, 2023
    Anticipated Primary Completion Date :
    Oct 1, 2028
    Anticipated Study Completion Date :
    Oct 1, 2028

    Arms and Interventions

    Arm Intervention/Treatment
    patients with sarcoma

    This is an observational prospective cohort study of 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)

    Outcome Measures

    Primary Outcome Measures

    1. To collect real-world observational clinical, radiographic, and molecular features [up to 5 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Memorial Sloan Kettering Cancer Center (All Protocol Activities) Basking Ridge New Jersey United States 07920
    2 Memorial Sloan Kettering Monmouth (All Protocol Activities) Middletown New Jersey United States 07748
    3 Memorial Sloan Kettering Bergen (All Protocol Activities) Montvale New Jersey United States 07645
    4 Memorial Sloan Kettering Cancer Center Suffolk- Commack (All Protocol Activities) Commack New York United States 11725
    5 Memorial Sloan Kettering Westchester (All Protocol Activities) Harrison New York United States 10604
    6 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    7 Memorial Sloan Kettering Nassau (All Protocol Activities) Uniondale New York United States 11553

    Sponsors and Collaborators

    • Memorial Sloan Kettering Cancer Center

    Investigators

    • Principal Investigator: Evan Rosenbaum, MD, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Memorial Sloan Kettering Cancer Center
    ClinicalTrials.gov Identifier:
    NCT06113315
    Other Study ID Numbers:
    • 23-254
    First Posted:
    Nov 2, 2023
    Last Update Posted:
    Nov 2, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Memorial Sloan Kettering Cancer Center
    Immunotherapy
    Immune Blockade-Based Therapy
    23-254
    Additional relevant MeSH terms:
    Sarcoma

    Study Results

    No Results Posted as of Nov 2, 2023