Pembrolizumab in Combination With Eftilagimod Alpha and Radiotherapy in Neoadjuvant Treatment of Patients With Soft Tissue Sarcoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-17

Study Completion Date

2027-04-30

Brief Summary

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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.

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Detailed Description

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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

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Neoadjuvant Immunotherapy Sarcoma,Soft Tissue Radiation Therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single arm

Systemic therapy with pembrolizumab and eftilagimod alfa is given concurrently with radiotherapy.

Surgery is scheduled 5-6 weeks after completion of radiotherapy.

Group Type OTHER

Pembrolizumab, Eftilagimod alfa

Intervention Type 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)

Interventions

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Pembrolizumab, Eftilagimod alfa

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)

Intervention Type DRUG

Other Intervention Names

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Keytruda Eftilagimod alfa Efti

Eligibility Criteria

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Inclusion Criteria

* 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;

Exclusion Criteria

* Ewing sarcoma, Alveolar and embryonal rhabdomyosarcoma
* Previous treatment with eftilagimod alfa, anti-PD-1 or anti-PD-L1;
* Prior radiotherapy to tumor-involved sites;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No