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Pembrolizumab, Eftilagimod alfa

Phase 2

Neoadjuvant | Small molecule | Oncology |Immutep Limited|Last Updated: Dec 8, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06128863Pembrolizumab in Combination With Eftilagimod Alpha and Radiotherapy in Neoadjuvant Treatment of Patients With Soft Tissue Sarcoma - EFTISARC-NEO TrialPHASE2 ACTIVE NOT_RECRUITING 40 — — Jul 17, 2023Apr 30, 2027Dec 8, 20251 Poland
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Study Endpoints
Primary Endpoints
Pathologic response
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.

Secondary Endpoints
Number of Participants Experiencing Adverse Events (AEs)
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
2 years
Disease-free survival (DFS)
From the date of curative surgery to the date of first recurrence or death (whatever the cause), whichever occurs first
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
single armOTHERSystemic therapy with pembrolizumab and eftilagimod alfa is given concurrently with radiotherapy. Surgery is scheduled 5-6 weeks after completion of radiotherapy.
Interventions
NameTypeDescription
Pembrolizumab, Eftilagimod alfaDRUGEftilagimod 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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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

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...

Countries:Poland
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06128863studyFirstPostDate: changed