SarcomaNCT06113315
A Study Involving Collection of Samples and Data From Sarcoma Patients Receiving Immunotherapy
An observational study of Sarcoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcoma
- How many people
- 250 participants
- Where
- 7 sitesUnited States
- Study dates
- 27 Oct 2023to Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Cancer Center Suffolk- Commack (All Protocol Activities)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (All Protocol Activities)
East White Plains, New York, 10604
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553
About this study
Official title: An Observational Study of Sarcoma Patients Treated With Immunotherapy at Memorial Sloan Kettering Cancer Center
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.
- Conditions
- Sarcoma
- Keywords
- Immunotherapy, 23-254
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
prospectively collect and store blood
of sarcoma patients treated with ICB or ACT
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start27 Oct 2023
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra D'Angelo, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113315
- Sponsor's protocol ID
- 23-254
- Status last verified
- Aug 2026
- First submitted
- 27 Oct 2023
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Sarcoma Patients Treated With Immunotherapy at Memorial Sloan Kettering Cancer Center
- ClinicalTrials.gov ID
- NCT06113315
- Acronym / sponsor ID
- 23-254
- Conditions
- Sarcoma
- Keywords
- Immunotherapy, 23-254
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prospectively collect and store blood
Time frame: up to 5 years
of sarcoma patients treated with ICB or ACT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sandra D'Angelo, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prospectively collect and store blood (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.