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New personalized vaccine aims to keep head and neck cancer from returning

NCT ID NCT04183166

Disease control Sponsor: Transgene 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a new personalized immunotherapy called TG4050 for people with advanced head and neck cancer. The treatment is designed to train the immune system to recognize and attack each patient's unique tumor mutations. The goal is to see if it is safe and can help prevent the cancer from coming back after standard treatment. About 80 participants will be randomly assigned to receive TG4050 or no additional treatment.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

80 people

The number who actually took part.

Started

Dec 2019

Expected to finish

Dec 2031

An estimate. End dates often move.

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.

Inclusion Criteria: 1. Signed written informed consent 2. Newly diagnosed stage III or IV, amenable to surgery (AJCC 8th edition) squamous-cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx 3. Female or male patients, aged at least 18 years 4. Patients in Complete Response after treatment of their primary tumor. 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 6. Adequate hematological, hepatic and renal functions Exclusion Criteria: 1. Patients with carcinoma of the nasopharynx, squamous cell-carcinoma of unknown primary, squamous cell carcinoma that originates from the skin and salivary gland or paranasal sinus, non-squamous histologies. 2. Prior exposure to anti-cancer vaccines and any antibody targeting T-cell co-regulatory proteins such as anti-PD1, anti-PDL1 or anti-CTLA4 antibodies. 3. Other active malignancy requiring concurrent systemic intervention. 4. Patients with previous malignancies other than the target malignancy to be investigated in this trial 5. Known history of positive testing for Human Immunodeficiency Virus (HIV) or known Acquired Immune Deficiency Syndrome (AIDS) 6. Clinical or laboratory history or evidence of Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) indicating acute or chronic infection 7. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 10 mIU/mL) 8. Treatment with another investigational agent since the beginning of the screening period 9. Uncontrolled intercurrent illness

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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.

Squamous cell carcinoma of head and neck

Contacts and locations

Locations

  • Aintree University Hospital NHS Fondation Trust

    Liverpool, L9 7AL, United Kingdom

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, 15076, Spain

  • Hospital Clínico San Carlos

    Madrid, 28040, Spain

  • Hospital Regional Universitario de Málaga - Hospital Civil

    Málaga, 29010, Spain

  • Hospital Universitari Vall d Hebrón

    Barcelona, 08035, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hôpital Saint André - CHU de Bordeaux

    Bordeaux, 33000, France

  • Hôpital de la Timone

    Marseille, 13000, France

  • IUCT Toulouse

    Toulouse, 31100, France

  • Institut Català d Oncologia - Hospital Duran i Reynals

    Barcelona, 08908, Spain

  • Institut Curie

    Paris, 75005, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224, United States

  • NHS Clatterbridge Cancer Center

    Liverpool, L7 8YA, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.