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Soluble LAG-3 Fusion Protein

Eftilagimod Alpha + Pembrolizumab for Head and Neck Cancer (TACTI-003 Trial)

Phase 2

Waitlist Available

Research Sponsored by Immutep S.A.S.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Availability of PD-L1 biomarker result by using the FDA approved Dako standardized diagnostic test (PD-L1 IHC 22C3 pharmDx).

Histologically- or cytologically-confirmed recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx that is considered incurable by local therapies and to be treated in the first line palliative setting and who are PD-X naïve.

Must not have

Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).

Disease is suitable for local therapy administered with curative intent.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug combination to see if it is more effective than just one of the drugs alone, for people with a certain type of cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include immune-related reactions such as inflammation in various organs, skin rash, fatigue, flu-like symptoms, hormonal gland problems, and infusion-related reactions from either drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I can carry out all my daily activities without help.

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I can provide a tissue sample for PD-L1 testing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My condition can be treated with the goal of curing it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: (CPS ≥1): pembrolizumab (KEYTRUDA®) + eftiExperimental Treatment2 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®) + eftiExperimental Treatment2 Interventions

Group III: (CPS ≥1): pembrolizumab (KEYTRUDA®)Active Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

eftilagimod alpha

2019

Completed Phase 2

~190

pembrolizumab (KEYTRUDA®)