Overview

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

Status:
Recruiting
Trial end date:
2025-03-01
Target enrollment:
0
Participant gender:
All
Summary
Evaluate the safety and efficacy of eftilagimod alpha in combination with pembrolizumab against pembrolizumab alone in 1st line metastatic or recurrent HNSCC with PD-L1 positive (CPS ≥1) tumors, and determine the efficacy and safety of efti plus pembrolizumab in patients with PD-L1 negative tumors.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Immutep S.A.
Immutep S.A.S.
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Pembrolizumab
Criteria
Main Inclusion Criteria:

1. 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.

2. Availability of tissue for PD-L1 biomarker analysis from a core or excisional biopsy.

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

4. Availability of tissue for testing of human papillomavirus (HPV) status for
oropharyngeal cancer (p16 expression testing).

5. ECOG performance status 0-1.

Main Exclusion Criteria:

1. Disease is suitable for local therapy administered with curative intent.

2. Previously treated with ≥ 1 systemic regimen for recurrent and/or metastatic disease
(with the exception of systemic therapy completed >6 months prior if given as part of
multimodal treatment for locally advanced disease).

3. Histologically or cytologically confirmed head and neck cancer of any other primary
anatomic location in the head and neck not specified in the inclusion criteria
including subjects with HNSCC of unknown primary, squamous cell carcinoma originating
from skin, or non-squamous histologies (e.g. nasopharynx, salivary gland or mucosal
melanoma).

4. Has progressive disease (PD) within 6 months of completion of curatively intended
systemic treatment for locoregionally advanced HNSCC.

5. 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).

6. Has received prior chemotherapy, anti-cancer monoclonal antibody, major surgery,
another systemic cancer therapy or has participated in a trial of an investigational
agent or has used an investigational device within 4 weeks prior to cycle 1 day 1.

7. Known active central nervous system metastasis and/or carcinomatous meningitis.
Subjects with previously treated brain metastases may participate provided they are
radiologically stable: i.e. without evidence of progression documented by repeat
imaging performed after therapy completed for CNS metastasis and with at least 4 weeks
difference, clinically stable and without requirement for steroid treatment for at
least 14 days prior to cycle 1 day 1.

8. Receives continuous systemic treatment with either corticosteroids (>10 mg daily
prednisone equivalents) or other immunosuppressive medications within 7 days prior to
cycle 1 day 1. Inhaled or topical steroids and physiological replacement doses of up
to 10 mg daily prednisone equivalents are permitted in the absence of active
auto-immune disease.