Tebentafusp in HLA-A*02:01 Positive Patients with advanced Clear Cell Sarcoma

A Phase II Trial of Tebentafusp in HLA-A*02:01 Positive Patients With Advanced Clear Cell Sarcoma

Agent: Tebentafusp vs. Physician’s choice
Phase II
Status Recruiting
Sponsor Sarcoma Alliance for Research through Collaboration (SARC)

 

For further information please also consult https://clinicaltrials.gov/study/NCT06942442

This is a multi-center, open label, phase II study of tebentafusp in patients with unresectable or metastatic clear cell sarcoma (CCS).

Patients who screen positive for HLA-A*02:01 and meet the eligibility requirements will be treated with weekly tebentafusp.

Radiographic assessment via CT or MR (where CT is not feasible or per the investigator's discretion) will occur at baseline and every subsequent 6 weeks through 48 weeks, and then every 9 weeks thereafter. Patients will be treated until progression of disease or unacceptable toxicity.

Patients who are HLA-A*02:01-negative and ineligible to receive tebentafusp will be prospectively enrolled onto a separate study arm and treated with physicians' choice of treatment. They will also be radiographically assessed at the same schedule as patients treated with tebentafusp, if feasible, and kept on this treatment arm until progression of disease or unacceptable toxicity on the physicians' choice regimen.

 

WHO is the trial for?
  • 18 Years and older
  • 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

Additional medical eligibility criteria apply and are reviewed by the study team.

WHAT is the key question that this trial is attempting to answer?

 Is treatment with Tebentafusp feasible and safe for patients with unresectable or metastatic clear cell sarcoma?

WHY patients might want to participate?

 This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in sarcomas and potentially help other patients with this disease.

The trial might or might not have benefit in your individual case.

WHEN will the trial be open?

 This study is open for recruitment.

WHERE is the trial available?

 The trial is being conducted in the US and United Kingdom.

For further information check here.

Contact:
Name: SARC Office
Phone Number: (734) 930-7600
Email: SARC045@sarctrials.org

STUDY DESIGN: What does the study look like?

 Open label design.

Drug: Tebentafusp

  • Patients who screen positive for HLA-A*02:01 and meet the eligibility requirements will be treated with weekly tebentafusp

Drug: Physician's Choice

  • Patients who are HLA-A*02:01-negative and ineligible to receive tebentafusp will be prospectively enrolled onto a separate study arm and treated with physicians' choice of treatment. They will also be radiographically assessed at the same schedule as patients treated with tebentafusp, if feasible, and kept on this treatment arm until progression of disease or unacceptable toxicity on the physicians' choice regimen.

HOW do I get more information?

 Patient organisations supporting sarcoma patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organisations serving sarcoma patients.

If there are no such organisation in your country, please email us for more information: info@sarcoma-patients.org

 

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken