BridgeMD
Phase II study evaluating the efficacy and safety of preoperative immunotherapy (pembrolizumab with eftilagimod alfa) in combination with radiotherapy in patients with operable soft tissue sarcomas.
EU CTIS ID: 2024-515971-37-00
What this study is testing
Evaluation of the efficacy of pembrolizumab and eftilagimod alfa in combination with preoperative radiotherapy in patients with resectable soft tissue sarcomas by analyzing the pathological response in the postoperative material.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Willing and able to provide written informed consent for the trial.
- Be ≥ 18 years of age on day of signing informed consent.
- Performance status of 0 to 1 on the ECOG Performance Scale.
- Primary or locally recurrent deep-seated extremities, girdles and/or superficial trunk (thoracic or abdominal wall) soft tissue sarcoma
- Size of the primary tumor >5 cm at instrumental staging (CT, MRI), or locally recurrent of any size
- Measurable disease based on RECIST 1.1
You likely can't join if
- Ewing sarcoma, Alveolar and embryonal rhabdomyoarcoma
- Previous treatment with eftilagimod alpha, anty-PD-1 or ant-PD-L1.
- Prior radiotherapy to tumor-involved sites.
- Subjects with active, known or suspected autoimmune disease or inflammatory bowel disease, which, in the opinion of the investigator, might impair the subject's tolerance of trial treatment. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring replacement therapy, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
- A concomitant disease that, in the opinion of the investigator, poses an unacceptable risk to the patient if he or she participates in the study
See the full eligibility criteria
- Willing and able to provide written informed consent for the trial.
- Be ≥ 18 years of age on day of signing informed consent.
- Performance status of 0 to 1 on the ECOG Performance Scale.
- Primary or locally recurrent deep-seated extremities, girdles and/or superficial trunk (thoracic or abdominal wall) soft tissue sarcoma
- Size of the primary tumor >5 cm at instrumental staging (CT, MRI), or locally recurrent of any size
- Measurable disease based on RECIST 1.1
- Non-metastatic disease.
- No previous systemic treatment for sarcoma.
- Grade 2 or 3 tumors according FNCLCC.
- Ewing sarcoma, Alveolar and embryonal rhabdomyoarcoma
- Previous treatment with eftilagimod alpha, anty-PD-1 or ant-PD-L1.
- Prior radiotherapy to tumor-involved sites.
- Subjects with active, known or suspected autoimmune disease or inflammatory bowel disease, which, in the opinion of the investigator, might impair the subject's tolerance of trial treatment. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring replacement therapy, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
- A concomitant disease that, in the opinion of the investigator, poses an unacceptable risk to the patient if he or she participates in the study
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.