NCT03625323

Combination Study With Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) and Pembrolizumab in Patients With Previously Untreated Unresectable or Metastatic NSCLC, or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic HNSCC

TACTI-002 (Two ACTive Immunotherapeutics): A Multicenter, Open Label, Phase II Study in Patients With Previously Untreated Unresectable or Metastatic Non-small Cell Lung Cancer (NSCLC), or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic Squamous Head and Neck Cancer (HNSCC) Receiving the Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) in Combination With Pembrolizumab (PD-1 Antagonist)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 187 (actual)
• Sponsor: Immutep S.A.S. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the safety and efficacy of the combination of eftilagimod alpha with pembrolizumab in non-small cell lung carcinoma and head and neck carcinoma patients.

Detailed description

Up to 187 patients will be recruited in the TACTI-002 (Two ACTive Immunotherapies) Phase II study which will take place across approximately 22 study centres in the U.S., Europe and Australia. It will evaluate the safety and efficacy of the combination of eftilagimod alpha with pembrolizumab in patients with advanced or metastatic non-small cell lung carcinoma or head and neck carcinoma. It will be a Simon's two-stage, non-comparative, open-label, single-arm, multicentre clinical study. Patients participating in the trial will be given the combination treatment for 12 months using a 30 mg s.c. eftilagimod alpha dosing every 2 or 3 weeks.

Conditions

• NSCLC
• HNSCC

Interventions

Type	Name	Description
DRUG	eftilagimod alpha	APC activator, MHC II agonist, LAG-3 fusion protein
DRUG	pembrolizumab (KEYTRUDA®)	anti-PD-1 antibody

Timeline

• Start date: 2019-02-18
• Primary completion: 2022-06-02
• Completion: 2024-11-25
• First posted: 2018-08-10
• Last updated: 2024-12-18
• Results posted: 2024-12-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study