Tebentafusp for Advanced Clear Cell Sarcoma
This study is testing a drug called tebentafusp for people with advanced clear cell sarcoma (a rare cancer of soft tissues) that cannot be removed by surgery or has spread. To join this part of the study, your cancer cells must have a specific marker called HLA-A*02:01. The study aims to see how well tebentafusp shrinks the cancer. There will be about 47 participants in total. If your cancer cells do not have the HLA-A*02:01 marker, you might be able to join a separate part of the study where you would receive a treatment chosen by your doctor. The current recruitment status for this study is unclear.
- Study design
- This is a Phase II, multi-center, open-label study. It will involve about 47 participants.
- What's involved
- If you receive tebentafusp, you will get weekly treatments. You will have CT or MRI scans at the start, every 6 weeks for 48 weeks, and then every 9 weeks. You will also have research biopsies and blood samples taken at specific times.
- Compensation
- Not stated in the trial record.
- Follow-up
- Disease response will be measured at approximately 5.5 months. Treatment continues until the disease gets worse or side effects are too severe.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06942442
A Phase II Trial of Tebentafusp in HLA-A*02:01 Positive Patients With Advanced Clear Cell Sarcoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentSarcoma Alliance for Research through CollaborationInvestigator-initiated
~47 participants
Updated 2025-12-26 on ClinicalTrials.gov
What's tested:Physician's ChoiceTebentafusp
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Measure Disease Response
Measured over Approximately 5.5 months
Conditions
NCT06942442
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Memorial Sloan Kettering Cancer Center
New York, New Yorkstudy coordinator listed
Recruiting
University of Southern California - Norris Cancer Center
Los Angeles, Californiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
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Eligibility criteria
Inclusion
Age 18 years
Histologically confirmed diagnosis of HMB-45+ clear cell sarcoma which is unresectable and/or metastatic
HLA-A\*02:01 positive
ECOG Performance Status of £ 2 at screening
At least one site of measurable disease on CT/MRI scan as defined by RECIST v 1.1 criteria. Baseline imaging must be performed within 28 days of Cycle 1 Day 1 of study.
Adequate organ function within 28 days of Day 1 of study defined as:
Absolute Neutrophil Count (ANC) ≥ 1.5
Platelets ≥ 75
ALT and AST ≤ 2.5 x institutional upper limit of normal (ULN) or ≤ 5.0 x institutional ULN if considered due to tumor
Alkaline phosphatase ≤ 2.5 x institutional ULN unless considered due to tumor
Serum bilirubin ≤ 1.5 x institutional ULN. NOTE: Patients with elevated bilirubin secondary to Gilbert's disease are eligible to participate in the study
Serum creatinine ≤ 1.5 x institutional ULN or 24-hour creatinine clearance ≥ 50 ml/min (calculated creatinine clearance using Cockroft formula is acceptable)
Written, voluntary informed consent
Patients must demonstrate progression of disease by RECIST 1.1 within 6 months of study enrollment. Newly diagnosed patients with unresectable or metastatic disease and only one baseline scan are eligible to screen and enroll.
All other relevant medical conditions must be well-managed and stable, in the opinion of the investigator, for at least 28 days prior to first administration of study drug
Exclusion
History of sever hypersensitivity reaction (e.g. anaphylaxis) to other biologic drugs or monoclonal antibodies
Clinically significant cardiac disease or impaired cardiac function, including any of the following:
Clinically significant and/or uncontrolled heart disease such as congestive heart failure (New York Heart Association grade ≥ 2), uncontrolled hypertension, or clinically significant arrhythmia currently requiring medical treatment
QTcF \> 470 msec on screening electrocardiogram (ECG) or congenital long QT syndrome. NOTE: If the initial automated QTcF interval is \> 470 msec at screening, for the purpose of determining eligibility, the mean QTcF, based on at least 3 ECGs obtained over a brief time interval (ie, within 30 minutes), should be manually determined by a medically qualified person.
Acute myocardial infarction or unstable angina pectoris \< 6 months prior to Screening
Presence of symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases that require doses of corticosteroids within the prior 3 weeks to study Day 1. Patients with brain metastases are eligible if lesions have been treated with localized therapy and there is no evidence of progression for at least 4 weeks by MRI prior to the first dose of study drug
Active infection requiring systemic antibiotic therapy. Patients requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to the first dose of study drug
Known history of uncontrolled human immunodeficiency virus (HIV) infection (defined as CD4 count \< 200 and/or a detectable viral load). Testing for HIV status is not necessary unless clinically indicated
Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection per institutional protocol. Testing for HBV or HCV status is not necessary unless clinically indicated or the patient has a history of HBV or HCV infection
Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers; any malignancy considered to be indolent and that has never required therapy; and completely resected carcinoma in situ of any type
Any medical condition that would, in the investigator's or Sponsor's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results
Patients receiving systemic steroid therapy or any other immunosuppressive medication at any dose level, as these may interfere with the mechanism of action of study treatment. Local steroid therapies (e.g., otic, ophthalmic, intra-articular or inhaled medications) are acceptable
History of adrenal insufficiency
Participants with clinically significant pulmonary disease or impaired lung function, including any of the following:
An oxygen saturation of \< 92% on room air, measured by pulse oximeter
History of interstitial lung disease
History of pneumonitis that required corticosteroid treatment or current pneumonitis
Ongoing requirement for intermittent or continuous oxygen supplementation
History of colitis or inflammatory bowel disease
Major surgery within 2 weeks of the first dose of study drug (minimally invasive procedures such as bronchoscopy, tumor biopsy, insertion of a central venous access device, and insertion of a feeding tube are not considered major surgery and are not exclusionary)
Radiotherapy within 2 weeks of the first dose of study drug, with the exception of palliative radiotherapy to a limited field, such as for the treatment of bone pain or a focally painful tumor mass
Use of hematopoietic colony-stimulating growth factors (eg, G-CSF, GM- CSF, M-CSF) ≤ 2 weeks prior to start of study drug. An erythroid-stimulating agent is allowed as long as it was initiated at least 2 weeks prior to the first dose of study treatment and the patient is not red blood cell transfusion dependent
Women who are pregnant or nursing/breastfeeding. Where pregnancy is defined as the state of a female after conception and until the termination of gestation.
Women of childbearing potential who are sexually active with a non- sterilized male partner, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception during study treatment (defined in Section 7.2.3), and must agree to continue using such precautions for 6 months after the final dose of investigational product: cessation of birth control after this point should be discussed with a responsible physician.
Male patients must be surgically sterile or use double barrier contraception methods from enrollment through treatment and for 6 months following administration of the last dose of study drug
What this trial measures
- Measure Disease ResponseApproximately 5.5 months
To estimate the population of HLA-A\*02:01-positive patients with metastatic or unresectable clear cell sarcoma and treated with tebentafusp who are progression free at 24 weeks. PFS (progression-free survival) will be determined using iRECIST.