Phase II Study of Tebentafusp for Patients with Advanced Clear Cell Sarcoma Who Are HLA-A*02:01 Positive

Sponsor: Sarcoma Alliance for Research through Collaboration

Sponsor score: 40

ClinicalTrials ID:NCT06942442

Provider View

This clinical trial is testing the drug tebentafusp in patients with advanced clear cell sarcoma that cannot be surgically removed or has spread to other parts of the body. The study focuses on patients who have a specific genetic marker, HLA-A*02:01.

Patient Parameters

Program Overview

This study is being conducted at multiple centers and involves patients with advanced clear cell sarcoma (CCS) that cannot be removed by surgery or has spread. Participants who test positive for the HLA-A*02:01 marker and meet other eligibility criteria will receive weekly doses of tebentafusp. The effectiveness of the treatment will be monitored through regular scans every six weeks for the first 48 weeks, and then every nine weeks. Patients will continue treatment until their disease progresses or they experience unacceptable side effects. Research biopsies and blood samples will be collected to help understand the treatment's effects.

Description

In this study, patients with advanced clear cell sarcoma who have the HLA-A02:01 marker will receive the drug tebentafusp once a week. The study will track the progress of the disease using CT or MRI scans at the start and then every six weeks for the first 48 weeks, followed by every nine weeks. Treatment will continue until the disease worsens or side effects become too severe. Participants will also have biopsies and blood samples taken to help researchers learn more about how the drug works. Patients who do not have the HLA-A02:01 marker will be placed in a different group and receive a treatment chosen by their doctor, with similar monitoring.

Eligibility Criteria

Exclusion Criteria

  • Severe allergic reactions to similar drugs.
  • Significant heart problems or uncontrolled heart disease.
  • Long QT syndrome or recent heart attack.
  • Untreated or symptomatic brain metastases.
  • Active infections needing antibiotics.
  • Uncontrolled HIV infection.
  • Active hepatitis B or C infection.
  • Other active cancers, except certain types that are not expected to spread.
  • Medical conditions that could interfere with the study.
  • Use of systemic steroids or immunosuppressive drugs.
  • History of adrenal insufficiency.
  • Significant lung disease or low oxygen levels.
  • History of bowel disease like colitis.
  • Recent major surgery or radiation therapy.
  • Recent use of certain growth factors.
  • Pregnant or breastfeeding women.
  • Women of childbearing potential not using effective contraception.
  • Men not using effective contraception.

Locations

FACILITYZIPCITYSTATE
Memorial Sloan Kettering Cancer Center10065New YorkNew York

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