TACTI-003 (Two ACTive Immunotherapeutics): A multicenter, open label, randomized, Phase II trial to investigate a soluble LAG-3 fusion protein, eftilagimod alpha (efti; IMP321) in combination with pembrolizumab (PD-1 antagonist) for first line treatment of subjects with unresectable recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-510762-16-00

Acronym

TACTI-003

Enrollment

127

Registered

2024-08-12

Start date

2021-11-30

Completion date

2025-11-05

Last updated

2025-07-07

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

Conditions

Metastatic head and neck squamous cell carcinoma (HNSCC)

Brief summary

Objective response rate (ORR) according to RECIST1.1

Detailed description

Overall survival (OS), Objective response rate (ORR) according to iRECIST, Time to and duration of responses according to iRECIST and RECIST 1.1, Disease control rate according to iRECIST and RECIST 1.1, Progression free survival (PFS) according to iRECIST and RECIST 1.1, Occurrence of anti-efti-specific antibodies, Safety profile in terms of frequency, severity and duration of Adverse events (AEs) and serious adverse events (SAEs) and events of clinical interest (ECI) and abnormalities in vital signs, physical examination, 12- lead ECG and safety laboratory assessments, Quality of Life using EORTC QLQ-H&N43 and EORTC QLQ-30

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGIMP321

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective response rate (ORR) according to RECIST1.1	—

Secondary

Measure	Time frame
Overall survival (OS), Objective response rate (ORR) according to iRECIST, Time to and duration of responses according to iRECIST and RECIST 1.1, Disease control rate according to iRECIST and RECIST 1.1, Progression free survival (PFS) according to iRECIST and RECIST 1.1, Occurrence of anti-efti-specific antibodies, Safety profile in terms of frequency, severity and duration of Adverse events (AEs) and serious adverse events (SAEs) and events of clinical interest (ECI) and abnormalities in vital signs, physical examination, 12- lead ECG and safety laboratory assessments, Quality of Life using EORTC QLQ-H&N43 and EORTC QLQ-30	—

Measure

Time frame

—

Countries

Belgium, Denmark, Germany, Romania, Spain

Outcome results

None listed

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