A Study Involving Collection of Samples and Data From Sarcoma Patients Receiving Immunotherapy
An Observational Study of Sarcoma Patients Treated With Immunotherapy at Memorial Sloan Kettering Cancer Center
1 other identifier
observational
250
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2023
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2023
CompletedStudy Start
First participant enrolled
October 27, 2023
CompletedFirst Posted
Study publicly available on registry
November 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
August 4, 2026
August 1, 2026
4.9 years
October 27, 2023
August 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
prospectively collect and store blood
of sarcoma patients treated with ICB or ACT
up to 5 years
Study Arms (2)
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).
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).
Eligibility Criteria
All sarcoma patients who will undergo or are undergoing ICB-based or ACT-based treatment at MSK will be approached for participation in this observational study.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center Suffolk- Commack (All Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
East White Plains, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553, United States
Related Links
Biospecimen
Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandra D'Angelo, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2023
First Posted
November 2, 2023
Study Start
October 27, 2023
Primary Completion (Estimated)
October 1, 2028
Study Completion (Estimated)
October 1, 2028
Last Updated
August 4, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.