Eftilagimod Alpha + Pembrolizumab for Head and Neck Cancer

(TACTI-003 Trial)

Recruiting at 28 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Immutep S.A.S.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for adults with recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) that can't be cured by surgery or other local treatments. They must have a certain level of PD-L1 protein in their tumors, good physical health (ECOG 0-1), and no prior systemic cancer treatment for the recurrent/metastatic disease. People with brain metastases stable after treatment may join.

Inclusion Criteria

My cancer has been tested for PD-L1 using an FDA-approved method.

My head or neck cancer has returned or spread and cannot be cured with treatment.

I can carry out all my daily activities without help.

Exclusion Criteria

I have previously been treated with specific immune system targeting drugs.

I have stable brain metastases and haven't needed steroids for 14 days.

I have had at least one treatment for my cancer after it came back or spread, but not within the last 6 months if it was part of a combined treatment approach for advanced but not spread cancer.

Treatment Details

Interventions

• Eftilagimod alpha (Soluble LAG-3 Fusion Protein)
• Pembrolizumab (Monoclonal Antibodies)

Trial Overview The study tests Eftilagimod alpha combined with Pembrolizumab versus Pembrolizumab alone in treating HNSCC. It aims to see if adding Eftilagimod improves outcomes for patients whose tumors express different levels of the PD-L1 protein.

Participant Groups

Group I: (CPS ≥1): pembrolizumab (KEYTRUDA®) + efti Experimental Treatment 2 Interventions

eftilagimod alpha: 30 mg every 2 weeks for the first 4 cycles;thereafter every 3 weeks for up to 18 cycles (1 cycle = 6 weeks). pembrolizumab (KEYTRUDA®): 400 mg every 6 weeks for up to 18 cycles (1 cycle = 6 weeks).

Group II: (CPS <1): pembrolizumab (KEYTRUDA®) + efti Experimental Treatment 2 Interventions

eftilagimod alpha: 30 mg every 2 weeks for the first 4 cycles;thereafter every 3 weeks for up to 18 cycles (1 cycle = 6 weeks). pembrolizumab (KEYTRUDA®): 400 mg every 6 weeks for up to 18 cycles (1 cycle = 6 weeks).

Group III: (CPS ≥1): pembrolizumab (KEYTRUDA®) Active Control 1 Intervention

pembrolizumab (KEYTRUDA®): 400 mg every 6 weeks for up to 18 cycles (1 cycle = 6 weeks).

Who Is Running the Clinical Trial?

Immutep S.A.S.

Lead Sponsor

Trials

15

Recruited

2,600+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University