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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-003845-36 | EudraCT Number |
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| Name | Class |
|---|---|
| Immutep S.A.S. | INDUSTRY |
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This is a phase II single-arm single-stage study evaluating efficacy and safety of pembrolizumab in combination with a soluble LAG-3 protein, eftilagimod alfa (Efti) and radiotherapy in neoadjuvant treatment of patients with soft tissue sarcomas. This study will determine the pathologic response rate (defined as percentage of tumor hyalinization/fibrosis) to the combination treatment.
Systemic therapy with pembrolizumab and eftilagimod alfa and radiotherapy are administered concurrently. Systemic treatment lasts for 9 weeks (study week 1-9). Radiation therapy lasts for 5 weeks (5 days per week) in weeks 2-6. Surgery takes place 5-6 weeks after completion of radiation therapy (week 11-12). Any adjuvant treatment (chemotherapy, immunotherapy, radiation therapy) after surgical treatment is not allowed. Patients will be then followed up regularly for a period of 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Other | Systemic therapy with pembrolizumab and eftilagimod alfa is given concurrently with radiotherapy. Surgery is scheduled 5-6 weeks after completion of radiotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab, Eftilagimod alfa | Drug | Eftilagimod alfa 20 mg s.c. every 2 weeks (5 doses), Pembrolizumab 200 mg i.v. every 3 weeks (3 cycles), Radiotherapy 50 Gy (25 x 2 Gy) |
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| Measure | Description | Time Frame |
|---|---|---|
| Pathologic response | The primary efficacy endpoint is a percent tumor hyalinization as a marker of response to treatment assessed at the time of surgical resection. | At the time of definitive surgical treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Adverse Events (AEs) | Safety analyses will include all patients who received at least one dose of study drug. Safety will be assessed through summaries of adverse events, changes in laboratory test results, changes in vital signs. Verbatim description of adverse events will be summarized and graded according to International Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. In addition, serious adverse events, severe adverse events (Grades 3, 4, and 5), and adverse events leading to study drug discontinuation or interruption will be summarized accordingly. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katarzyna Kozak | Maria Sklodowska-Curie National Research Institute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maria Sklodowska-Curie National Research Institute of Oncology | Warsaw | 00-738 | Poland |
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| All adverse events will be documented from the enrolment of the first patient until 100 days after the surgical treatment of the last patient (2 years). |
| Number of participants completing neoadjuvant therapy | Number of patients completing neoadjuvant treatment and having a curative surgery according to the protocol | 2 years |
| Disease-free survival (DFS) | Disease-free survival (DFS) is defined as the time from between the date of curative surgery and the date of disease recurrence defined as clinically diagnosed or biopsy-confirmed recurrent sarcoma at a site of the primary tumor, development of nodal metastasis, locoregional recurrence or distant metastases confirmed by imaging or clinical examination, or death without documented recurrence | From the date of curative surgery to the date of first recurrence or death (whatever the cause), whichever occurs first |
| Local recurrence-free survival (LRFS) | Local recurrence-free survival (LRFS) is defined as the time between the date of curative surgery and the date of local recurrence confirmed by imaging or clinical examination. Patients still alive and without signs of disease recurrence at the analysis cut-off date are censored at the last date known to be alive. | From the date of curative surgery to the date of first local recurrence or date of death (whatever the cause), whichever occurs first |
| Distant metastasis-free survival (DMFS) | Distant metastasis-free survival (DMFS) is defined as the time between the date of curative surgery to the date of diagnosis of distant metastases confirmed by imaging or clinical examination. Patients still alive and without signs of distant metastases at the analysis cut-off date are censored at the last date known to be alive. | From the date of curative surgery to the date of first distant metastasis or date of death (whatever the cause), whichever occurs first |
| Overall survival (OS) | Overall survival (OS) is defined as the time between the date of curative surgery and the date of death from any cause. For those without documentation of death, OS will be censored on the last date the participant was known to be alive. | From the date of curative surgery up to the date of death or the last date the participant was known to be alive |
| Response rate | Radiologic Response To Neoadjuvant Treatment using RECIST 1.1 | From the date of the first dose of treatment to the date of curative surgery |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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