A Study Involving Collection of Samples and Data From Sarcoma Patients Receiving Immunotherapy

NCT ID: NCT06113315

Last Updated: 2025-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-27

Study Completion Date

2028-10-31

Brief Summary

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The researchers are doing this study to improve their knowledge about immunotherapy use and how effective it is as a treatment for people with sarcoma by collecting information from participants' medical records who have been treated with immune checkpoint blockade or T-cell receptor-based therapy.

Detailed Description

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Conditions

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Sarcoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment-naïve patients who have not received any ICB and/or ACT treatment at time of consent

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) or adoptive cell therapy (ACT; tumor infiltrating lymphocytes and/or engineered T cell receptor therapy) at Memorial Sloan Kettering Cancer Center (MSK).

No interventions assigned to this group

Treatment-experienced patients who have already received ICB and/or ACT treatment at time of consent

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) or adoptive cell therapy (ACT; tumor infiltrating lymphocytes and/or engineered T cell receptor therapy) at Memorial Sloan Kettering Cancer Center (MSK).

No interventions assigned to this group

Eligibility Criteria

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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 OR any prospectively identified patient being treated or to be treated with ACT-based treatment including but not limited to lifileucil, Afamitresgene autoleucel, and letetresgene autoleuce 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 or ACT initiation), during, and after ICB or ACT treatment
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandra D'Angelo, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Basking Ridge, New Jersey, United States

Site Status

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States

Site Status

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States

Site Status

Memorial Sloan Kettering Cancer Center Suffolk- Commack (All Protocol Activities)

Commack, New York, United States

Site Status

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

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23-254

Identifier Type: -

Identifier Source: org_study_id

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