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Pembrolizumab in Combination With Eftilagimod Alpha and Radiotherapy in Neoadjuvant Treatment of Patients With Soft Tissue Sarcoma - EFTISARC-NEO Trial

Study acronym: EFTISARC-NEO
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Interventions: Pembrolizumab, Eftilagimod alpha (Drug) to Pembrolizumab, Eftilagimod alfa (Drug)
    • Eligibility criteria revised
    • Study description revised
    v4
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v3
  3. Eligibility criteria shortened, about 36 wordsv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06128863
Lead Sponsor Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators: Immutep S.A.S.
Conditions
(from sponsor)		 Neoadjuvant, Immunotherapy, Sarcoma,Soft Tissue, Radiation Therapy
Related terms Sarcoma
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov