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Combination Study With Eftilagimod Alpha (a Soluble LAG-3 Fusion Protein) and Pembrolizumab in Patients With Recurrent or Metastatic HNSCC

NCT04811027 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2025-12-11

No results posted yet for this study

Summary

Evaluate the safety and efficacy of eftilagimod alpha in combination with pembrolizumab against pembrolizumab alone in 1st line metastatic or recurrent HNSCC with programmed death-ligand 1 (PD-L1) positive (combined positive score \[CPS\] ≥1) tumors, and determine the efficacy and safety of efti plus pembrolizumab in patients with PD-L1 negative tumors.

Conditions

  • HNSCC

Interventions

DRUG

eftilagimod alpha

APC activator, MHC II agonist, LAG-3 fusion protein

DRUG

pembrolizumab (KEYTRUDA®)

anti-PD-1 antibody

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-27
Primary Completion
2024-03-11
Completion
2025-11-05
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Denmark
  • Germany
  • Romania
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04811027 on ClinicalTrials.gov