NeoadjuvantPhase 2EFTISARC-NEONCT06128863
Pembrolizumab in Combination With Eftilagimod Alpha and Radiotherapy in Neoadjuvant Treatment of Patients With Soft Tissue Sarcoma - EFTISARC-NEO Trial
A Phase 2 study testing Pembrolizumab, Eftilagimod alfa in people with Neoadjuvant and Immunotherapy, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoadjuvant, Immunotherapy, Sarcoma,Soft Tissue
- What is being tested?
- Pembrolizumab, Eftilagimod alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 17 Jul 2023to 30 Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary or locally recurrent deep-seated extremities, girdles and/or superficial trunk (thoracic or abdominal wall) soft tissue sarcoma
- Grade 2 or 3 tumors according to Fédération Nationale des Centres de Lutte contre le Cancer (FNCLCC);
- 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;
Who cannot join
- Ewing sarcoma, Alveolar and embryonal rhabdomyosarcoma
- Previous treatment with eftilagimod alfa, anti-PD-1 or anti-PD-L1;
- Prior radiotherapy to tumor-involved sites;
Trial locations and contacts
1 site in 1 country.
Poland1 site
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, 00-738
About this study
Official title: Phase II, Single-arm Clinical Trial Evaluating Efficacy and Safety of Pembrolizumab in Combination With a Soluble LAG-3 Protein, Eftilagimod Alpha, and Radiotherapy in Neoadjuvant Treatment of Patients With Soft Tissue Sarcomas (EFTISARC-NEO)
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.
Read the detailed description
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.
- Conditions
- Neoadjuvant, Immunotherapy, Sarcoma,Soft Tissue, Radiation Therapy
- Being tested
- Pembrolizumab, Eftilagimod alfa
- Keywords
- soft tissue sarcoma, immunotherapy
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pembrolizumab, Eftilagimod alfaDrug
Also called Keytruda, Eftilagimod alfa, Efti
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Pembrolizumab, Eftilagimod alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of definitive surgical treatment
Secondary outcomes (7)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: From the date of the first dose of treatment to the date of curative surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start17 Jul 2023
- Primary completion30 Apr 2025
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoadjuvantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Immutep S.A.S.
- Responsible party
- Sponsor
- Investigators
- Katarzyna Kozak, Principal investigator, Maria Sklodowska-Curie National Research Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128863
- Sponsor's protocol ID
- EFTISARC-NEO/NIO-0004
- Other IDs
- 2022-003845-36
- Acronym
- EFTISARC-NEO
- Status last verified
- Feb 2025
- First submitted
- 28 Oct 2023
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Single-arm Clinical Trial Evaluating Efficacy and Safety of Pembrolizumab in Combination With a Soluble LAG-3 Protein, Eftilagimod Alpha, and Radiotherapy in Neoadjuvant Treatment of Patients With Soft Tissue Sarcomas (EFTISARC-NEO)
- ClinicalTrials.gov ID
- NCT06128863
- Acronym / sponsor ID
- EFTISARC-NEO / EFTISARC-NEO/NIO-0004
- Conditions
- Neoadjuvant, Immunotherapy, Sarcoma,Soft Tissue, Radiation Therapy
- Keywords
- soft tissue sarcoma, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Collaborators
- Immutep S.A.S.
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Other | Drug: Pembrolizumab, Eftilagimod alfaSystemic therapy with pembrolizumab and eftilagimod alfa is given concurrently with radiotherapy. Surgery is scheduled 5-6 weeks after completion of radiotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary or locally recurrent deep-seated extremities, girdles and/or superficial trunk (thoracic or abdominal wall) soft tissue sarcoma
- Grade 2 or 3 tumors according to Fédération Nationale des Centres de Lutte contre le Cancer (FNCLCC);
- 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;
Key exclusion criteria (3 listed)
- Ewing sarcoma, Alveolar and embryonal rhabdomyosarcoma
- Previous treatment with eftilagimod alfa, anti-PD-1 or anti-PD-L1;
- Prior radiotherapy to tumor-involved sites;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pembrolizumab, Eftilagimod alfaAlso: Keytruda, Eftilagimod alfa, EftiEftilagimod 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) | Drug | single arm |
Primary outcome
Pathologic response
Time frame: At the time of definitive surgical treatment
The primary efficacy endpoint is a percent tumor hyalinization as a marker of response to treatment assessed at the time of surgical resection.
7 secondary outcomes
Number of Participants Experiencing Adverse Events (AEs)
Time frame: 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
Time frame: 2 years
Disease-free survival (DFS)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: From the date of the first dose of treatment to the date of curative surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katarzyna Kozak principal investigator
Maria Sklodowska-Curie National Research Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab, Eftilagimod alfa in people with Neoadjuvant and Immunotherapy, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic response (time frame: At the time of definitive surgical treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.