Sarcoma Clinical Trials

The Sarcoma Foundation of America Clinical Trial Matching Service

The Sarcoma Foundation of America Clinical Trial Matching Service offers patients, caregivers and health care professionals up-to-date information about sarcoma cancer clinical trials throughout the United States and Canada. The service is provided in collaboration with EmergingMed and will help you quickly search for clinical trial options that match your specific diagnosis and treatment history.

This free and confidential service is designed to allow you to begin the search process online. However, we recommend that visitors begin the process by calling our toll-free number: 800-536-8718 or go to SFA Clinical Trial Matching Service.

Clinical Trials Resource Center

Welcome to the Sarcoma Foundation of America’s Clinical Trials Resource Center presented in partnership with CenterWatch.com, the leading publisher of information on clinical research for patients and their advocates. Please click on the links below to learn more about clinical research and new medical therapies.


Actively Recruiting Clinical Trials*

*For a comprehensive list, please go to the Patient Resources section at the bottom of the page.

Brightline-1: A Study to Compare BI 907828 With Doxorubicin in People with a Type of Cancer Called Dedifferentiated Liposarcoma 

This study is open to people with a type of cancer called dedifferentiated liposarcoma. People with advanced liposarcoma aged 18 or older who are not receiving any other cancer treatment can participate. 

The purpose of this study is to compare a medicine called BI 907828 with doxorubicin in people with liposarcoma. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. Doxorubicin is a medicine already used to treat cancer including liposarcoma. 

During the study, participants get either BI 907828 or doxorubicin. Every 3 weeks, participants take BI 907828 as tablets or doxorubicin as an infusion into a vein. Participants can switch to BI 907828 treatment if they did not benefit from doxorubicin treatment. 

Participants can continue treatment in the study as long as they benefit from it and can tolerate it. 

Doctors regularly check the size of the tumor and check whether it has spread to other parts of the body. The doctors also regularly check participants’ health and take note of any unwanted effects 

ClinicalTrials.gov:  https://clinicaltrials.gov/ct2/show/NCT05218499
Sponsor website:  https://brightline-1.researchstudytrial.com/


A Phase 1, Multicenter, Open-Label, Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Clinical Activity of Intravenously Administered FHD-609 in Subjects with Advanced Synovial Sarcoma.

This study is an ascending multiple dose clinical trial with expansion arms. It is primarily intended to evaluate the safety and tolerability of FHD-609 when administered intravenously to subjects with advanced synovial sarcoma. The Dose Escalation Phase will allow for the determination of the recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) in subjects with advanced synovial sarcoma. This study will also evaluate the PK/PD profiles of multiple dose administration of FHD-609.

The Dose Expansion Phase will allow a more robust evaluation of the safety profile of FHD-609, including toxicities that may occur less frequently, and an assessment of anti-tumor activity. The data from this study in subjects with advanced synovial sarcoma, including safety, tolerability, PK/PD findings, and anti-tumor activity, will form the basis for potential subsequent clinical development of FHD-609.

The main purpose of this study is to evaluate the safety and tolerability of FHD-609. To be eligible to participate in this study, patients must be at least 16 years of age with advanced synovial sarcoma. [Note: 16 if minimum body weight test is met, otherwise 18.]

ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT04965753?term=fhd-609&draw=2&rank=1
Sponsor website: https://foghorntx.com/


YH001 Plus Envafolimab With or Without Doxorubicin in Patients With Advanced or Metastatic Sarcoma

This is a multicenter, open label, Phase 1/2 study of YH001 initially given in combination with envafolimab, and then given in combination with envafolimab plus doxorubicin in patients with advanced or metastatic sarcoma, followed by Phase 2 cohorts of patients with select histologies of advanced or metastatic sarcoma.

ClinicalTrials.gov:  https://clinicaltrials.gov/ct2/show/NCT05448820?term=envafolimab&draw=3
Sponsor website:   www.traconpharma.com


ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma (ENVASARC)

This is a multicenter open-label, randomized, non-comparative, parallel cohort pivotal study of treatment with envafolimab (cohort A and C) or envafolimab combined with ipilimumab (cohort B and D) in patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS)/myxofibrosarcoma (MFS) who have progressed on one or two lines of chemotherapy.

ClinicalTrials.gov:  https://clinicaltrials.gov/ct2/show/NCT04480502?term=envafolimab&draw=4
Sponsor website: www.traconpharma.com


An open-label, single-arm, multicohort, Phase 2 study to assess the efficacy and safety of tabelecleucel in subjects with Epstein-Barr virus-associated diseases

This is a multi-cohort, Phase 2, single arm, open label study of tabelecleucel (allogenic EBV-specific T-cell immunotherapy) in patients with EBV+ sarcoma, to include leiomyosarcoma (one of six cohorts). Patients can be newly diagnosed or failed a first-line therapy for EBV+ sarcoma. Newly diagnosed patients should be ineligible to receive standard first-line therapy. Primary objective is to evaluate the clinical benefit of tabelecleucel.

ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT04554914
Sponsor website: www.atarabio.com


SM-88 as Maintenance Therapy for Advanced Ewing’s Sarcoma Patients and as Salvage Therapy for Sarcoma Patients (HopES)

This clinical trial evaluates the efficacy and safety of an oral investigational drug (SM-88) in two groups of patients: 1) as maintenance therapy following standard primary or palliative treatments for Ewing’s sarcoma patients with high risk of relapse or disease progression; and 2) as salvage therapy for patients with clinically advanced sarcomas.

The primary objective is to evaluate the efficacy of SM-88, a combination metabolic cancer treatment, measured as positive efficacy events or progression free survival at least 1.5 times longer than the last prior line of treatment.

ClinicalTrials.gov: https://www.clinicaltrials.gov/ct2/show/NCT03778996
Sponsor Website: https://tymesm88hopessarcomatrial.com/


Phase 1 Trial of the LSD1 Inhibitor Seclidemstat (SP-2577) with and without Topotecan and Cyclophosphamide in Patients with Relapsed or Refractory Ewing Sarcoma and Select Sarcomas

This is an open label, phase I trial to evaluate the safety of an orally administered targeted agent, seclidemstat (LSD1 inhibitor) in combination with cyclophosphamide and topotecan, in patients with relapsed or refractory Ewing sarcoma who have received at least one line of prior treatment for Ewing sarcoma. The trial also enrolls both myxoid liposarcoma and Ewing-related sarcomas which share a similar translocation gene as Ewing sarcoma, who have received at least two prior lines of treatment for their sarcoma. The myxoid liposarcoma and translocated sarcoma patients will be enrolled to single-agent seclidemstat. This trial has completed the dose escalation phase of the trial and is now in dose expansion. The primary objective is safety and tolerability of seclidemstat, alone, and in combination with standard chemotherapy.

ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT03600649?term=salarius&draw=2&rank=2
Sponsor Website: http://salariuspharma.com/


Genetically Engineered PBMC and PBSC Expressing NY-ESO-1 TCR After a Myeloablative Conditioning Regimen to Treat Patients With Advanced Cancer (NYESO SCT)

This phase I clinical trial evaluates the safety and feasibility of administering NY-ESO-1 TCR (T cell receptor) engineered peripheral blood mononuclear cells (PBMC) and peripheral blood stem cells (PBSC) after a myeloablative conditioning regimen to treat patients with cancer that has spread to other parts of the body. The conditioning chemotherapy makes room in the patient’s bone marrow for new blood cells (PBMC) and blood-forming cells (stem cells) to grow. Giving NY-ESO-1 TCR PBMC and stem cells after the conditioning chemotherapy is intended to replace the immune system with new immune cells that have been redirected to attack and kill the cancer cells and thereby improve immune system function against cancer.

ClinicalTrials.gov:  https://clinicaltrials.gov/ct2/show/NCT03240861?term=NCT03240861&rank=1


Study of LOXO-101 in Subjects With NTRK Fusion Positive Solid Tumors

This phase 2 study will enroll patients of all tumor types, including sarcomas, who have a specific abnormality in the tumor called a fusion of one of the cancer cell’s NTRK genes (NTRK -1, -2, or -3) which may cause the sarcoma to grow.  The study drug, LOXO-101, is a capsule and acts by blocking the effects of the NTRK fusions in these cancers.   This study will measure how well and for how long LOXO-101 works.   Patients with a sarcoma who would not be able to receive any other options for treatment can participate in this trial.  If you are not sure if your cancer has one of these NTRK fusions, talk to your doctor about available options to have your tumor tissue tested.

ClinicalTrials.gov:  https://clinicaltrials.gov/ct2/show/NCT02576431?term=NCT02576431&draw=2&rank=1


Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK1/2/3, ROS1, or ALK Gene Rearrangements (Fusions) (STARTRK-2)

The Studies of Tumor Alterations Responsive to Targeting Receptor Kinases-2 (STARTRK-2) is a global, Phase 2 multi-site basket study designed to evaluate the clinical effectiveness and safety of entrectinib  (RXDX-101) as a targeted cancer therapy (ClinicalTrials.gov identifier NCT02568267). In Phase 1 trials, this once-daily, oral medication has demonstrated an overall response rate of 72% among patients with NTRK1, NTRK2, NTRK3, ROS1 or ALK gene rearrangements who were treated at or above the recommended Phase 2 dose level.  STARTRK-2 is currently enrolling patients with these gene rearrangements, which are present in some sarcomas.

For patients of any sarcoma subtype with unknown NTRK1, NTRK2, NTRK3, ROS1 or ALK gene rearrangement status, Ignyta’s CAP-accredited central diagnostic lab will perform testing on archival tumor tissue at no cost to patients.

If you’re unsure whether your sarcoma has one of these rearrangements, we encourage you to talk to your doctor and ask to get your tissue checked.    #STARTRK #NTRK1 #NTRK2 #NTRK3 #ROS1 #ALK #Ignyta #entrectinib

ClinicalTrials.gov:  https://www.clinicaltrials.gov/ct2/show/NCT02568267?term=NCT02568267&rank=1


Patient Resources

About Clinical Research
Background information about the clinical trials process and what to expect when you volunteer to participate in a clinical trial. Here, you’ll find answers to frequently asked questions about clinical trials and also suggestions for where to find more information.

CenterWatch Clinical Trials Listing Service
Database of industry sponsored clinical trial listings for Sarcoma.

Listing of Studies at ClinicalTrials.gov
Link to ClinicalTrials.gov, a comprehensive listing of federally and privately supported clinical trials. The U.S. National Institutes of Health (NIH), through its National Library of Medicine (NLM), has developed this site in collaboration with the Food and Drug Administration (FDA).

Profiles of Research Centers
Detailed descriptions of centers that conduct clinical research in the field of Oncology. Profiles include an overview of each center, descriptions of clinical research investigators and staff, and links to currently enrolling clinical research studies.

New FDA Drug Approvals
Database of new medical treatments approved by the FDA since 1995. Detailed summary descriptions for each drug are provided including drug name; manufacturer; mechanism of action; clinical trial results, and side effect profile.

CenterWatch Bookstore
Descriptions of all of CenterWatch’s publications for patients and for clinical research professionals.

Clinical Trials search site
The NCI has developed this premier site.  Just type in osteosarcoma, soft tissue sarcoma, etc., or refine the search to your personal interests.