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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)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515971-37-00
Acronym
EFTISARC-NEO/NIO0004
Enrollment
40
Registered
2024-10-30
Start date
2023-07-17
Completion date
Unknown
Last updated
2025-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resectable soft tissue sarcomas

Brief summary

The pathological response, defined as percentage of fibrosis and hyalinization found in the surgical specimen after completion of preoperative treatment.

Detailed description

Treatment safety profile, Number of patients completing neoadjuvant treatment and having a curative surgery according to the protocol., Disease-free survival time (DFS), Local recurrence-free survival (LRFS), Distant metastasis-free survival (DMFS), Overall survival (OS), Overall response rate (ORR) by RECIST 1.1 criteria, Exploratory endpoints include the search for biomarkers and correlations between their occurrence and response to treatment

Interventions

DRUGIMP321
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Sponsors

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy, Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The pathological response, defined as percentage of fibrosis and hyalinization found in the surgical specimen after completion of preoperative treatment.—

Secondary

MeasureTime frame
Treatment safety profile, Number of patients completing neoadjuvant treatment and having a curative surgery according to the protocol., Disease-free survival time (DFS), Local recurrence-free survival (LRFS), Distant metastasis-free survival (DMFS), Overall survival (OS), Overall response rate (ORR) by RECIST 1.1 criteria, Exploratory endpoints include the search for biomarkers and correlations between their occurrence and response to treatment—

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026