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New combo therapy shows promise for tough head and neck cancers

NCT ID NCT04811027

Disease control Sponsor: Immutep S.A.S. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested whether adding eftilagimod alpha to the immunotherapy pembrolizumab works better than pembrolizumab alone for people with advanced head and neck cancer that cannot be removed by surgery. The study included 171 participants whose tumors had certain markers. Researchers measured how many patients' tumors shrank or disappeared, and how long they lived.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

171 people

The number who actually took part.

Started

Aug 2021

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. Eastern Cooperative Oncology Group (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 or locoregionally 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 locally or locoregionally advanced HNSCC, or requires chemotherapy based therapeutic regimen due to e.g., rapidly progressing disease or need of aggressive sympton control. 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.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HNSCC

Contacts and locations

Locations

  • AZ Nikolaas

    Sint-Niklaas, 9100, Belgium

  • AZ Sint-Jan Brugge

    Bruges, 8000, Belgium

  • Antwerp University Hospital

    Edegem, 2650, Belgium

  • Arensia Exploratory Medicine Llc

    Kapitanivka, AL, 08112, Ukraine

  • Centre Hospitalier Universitaire (CHU) de Liege

    Liège, 4000, Belgium

  • Herlev Hospital

    Herlev, 2700, Denmark

  • Hospital 12 Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Lucus Augusti

    Lugo, 27003, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital de la Santa Creu i de Sant Pau

    Barcelona, 08041, Spain

  • Institut Català d'Oncologia - Hospital Universitari de Girona

    Girona, 17007, Spain

  • Institute of Cancer Science - Beatson West of Scotland Cancer Centre

    Glasgow, 1053, United Kingdom

  • Macquarie University Hospital

    Macquarie Park, New South Wales, 2109, Australia

  • Nationales Centrum für Tumorerkrankungen Heidelberg

    Heidelberg, 69120, Germany

  • Nottingham University Hospitals, NHS Trust

    Nottingham, NG5 1PB, United Kingdom

  • Oncology Consultants

    Houston, Texas, 77030, United States

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • START Madrid (Hospital Universitario Fundación Jiménez Díaz)

    Madrid, 28040, Spain

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • The Oncology Institute "Prof Dr Ion Chiricuta" I.O.C.N.

    Cluj-Napoca, 400015, Romania

  • University College London Hospitals NHS Foundation - The Harley Street Clinic

    London, NW1 2PG, United Kingdom

  • University Hospital Essen

    Essen, 45147, Germany

  • University of Alabama at Birmingham (UAB) - O'Neal Cancer Center

    Birmingham, Alabama, 35249, United States

  • Universitätsklinikum Bonn

    Bonn, North Rhine-Westphalia, 53127, Germany

  • Universitätsklinikum Ulm

    Ulm, 89075, Germany

  • Vall d'Hebron Institute of Oncology (VHIO)

    Barcelona, 08035, Spain

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

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