Squamous Cell Carcinoma of Head and NeckPhase 1/2NCT04183166
A Clinical Trial Evaluating TG4050 in Head and Neck Cancer
A Phase 1/2 study testing TG4050 in people with Squamous Cell Carcinoma of Head and Neck, run by Transgene at 14 sites in 4 countries.
Trial summary
This is a multicenter, open-label, two arms, randomized, phase I/II study evaluating the safety and tolerability as well as some activity parameters of TG4050 in patients with squamous cell carcinoma of the head and neck (SCCHN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- TG4050
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 14 sitesin 4 countries
- Study dates
- 12 Dec 2019to 30 Dec 2031
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Newly diagnosed stage III or IV, amenable to surgery (AJCC 8th edition) squamous-cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
- Female or male patients, aged at least 18 years
- Patients in Complete Response after treatment of their primary tumor.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Adequate hematological, hepatic and renal functions
Who cannot join
- 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.
- 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.
- Other active malignancy requiring concurrent systemic intervention.
- Patients with previous malignancies other than the target malignancy to be investigated in this trial
- Known history of positive testing for Human Immunodeficiency Virus (HIV) or known Acquired Immune Deficiency Syndrome (AIDS)
- Clinical or laboratory history or evidence of Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) indicating acute or chronic infection
Show all 9Show fewer
- 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)
- Treatment with another investigational agent since the beginning of the screening period
- Uncontrolled intercurrent illness
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
Spain6 sites
Hospital Universitari Vall d Hebrón
Barcelona, 08035
Institut Català d Oncologia - Hospital Duran i Reynals
Barcelona, 08908
Hospital Clínico San Carlos
Madrid, 28040
Hospital Universitario La Paz
Madrid, 28046
Hospital Regional Universitario de Málaga - Hospital Civil
Málaga, 29010
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, 15076
France5 sites
Hôpital Saint André - CHU de Bordeaux
Bordeaux, 33000
Hôpital de la Timone
Marseille, 13000
Institut Curie
Paris, 75005
IUCT Toulouse
Toulouse, 31100
Institut Gustave Roussy
Villejuif, 94805
United Kingdom2 sites
NHS Clatterbridge Cancer Center
Liverpool, L7 8YA
Aintree University Hospital NHS Fondation Trust
Liverpool, L9 7AL
United States1 site
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
About this study
Official title: A Randomized Phase I/II Trial in Patients With Newly Diagnosed, Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Evaluating a Mutanome-directed Immunotherapy.
This is a multicenter, open-label, two arms, randomized, phase I/II study evaluating the safety and tolerability as well as some activity parameters of TG4050 in patients with squamous cell carcinoma of the head and neck (SCCHN).
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Being tested
- TG4050
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TG4050Drug
Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm A : Early study treatment initiation | Experimental | TG4050 treatment initiation at completion of primary treatment Receives: Drug: TG4050 |
| Arm B: Study treatment initiation at recurrence | Experimental | TG4050 treatment initiation at the time of recurrence Receives: Drug: TG4050 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Safety and tolerability (Adverse Event reported per CTCAE v5)
Incidence of Adverse Event reported per CTCAE v5.
Measured: Up to 2 Years.
Phase I/II: Disease-Free Survival
Time from randomization to documented recurrence of disease.
Measured: Up to 2 years.
Secondary outcomes (6)
Phase I: Disease-Free Survival
Time from randomization to documented recurrence of disease.
Measured: Up to 2 Years.
Phase I: Tumor response rate
Percentage of patients whose best overall response is either a Complete Response or a Partial Response according to RECIST version 1.1 criteria.
Measured: Up to 2 years.
Phase I/II: Safety and tolerability (Adverse Event reported per CTCAE v5)
Incidence of Adverse Event reported per CTCAE v5.
Measured: Up to 2 years.
Phase I/II: Distant Metastases-Free Survival
Time from randomization to documented first occurrence of distant metastasis.
Measured: Up to 2 years.
Phase I/II: Loco-Regional Relapse-Free Survival
Time from randomization to documented loco-regional recurrence.
Measured: Up to 2 years.
Phase I/II: Overall Response Rate in patients with recurrent disease
Percentage of patients with a best overall response of complete response or partial response according to RECIST, version 1.1 criteria.
Measured: Up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start12 Dec 2019
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Transgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183166
- Sponsor's protocol ID
- TG4050.02
- Status last verified
- Jan 2026
- First submitted
- 21 Nov 2019
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ottensmeier C, Delord JP, Lalanne A, Jamet C, Le Gac AL, Bidet Huang K, Grellier B, Deforges J, Brandely M, Quemeneur E, Bastien B, Tavernaro A, Lacoste G, Schoettel V, Spring-Giusti C, Silvestre N, Marchand JB, Robin S, Dochy E, Ceppi M, Riva A, Yamagata N, Brattas P, Onoguchi K, Yamashita Y, Fontenelle H, Eggert Martinez M, Baker O, Jones T, Schache A, Piaggio E, Bendjama K, Lantz O, Le Tourneau C. A viral-based individualized neoantigen vaccine as adjuvant treatment in resected head and neck squamous cell carcinoma: a randomized Phase I trial. Nat Commun. 2026 Aug 17;17(1):9863. doi: 10.1038/s41467-026-76667-1.
PubMed 42744798
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase I/II Trial in Patients With Newly Diagnosed, Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Evaluating a Mutanome-directed Immunotherapy.
- ClinicalTrials.gov ID
- NCT04183166
- Acronym / sponsor ID
- TG4050.02
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- TransgeneIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2031 (estimated)
- First posted
- 3 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, open-label, two arms, randomized, phase I/II study evaluating the safety and tolerability as well as some activity parameters of TG4050 in patients with squamous cell carcinoma of the head and neck (SCCHN).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A : Early study treatment initiation | Experimental | Drug: TG4050TG4050 treatment initiation at completion of primary treatment |
| Arm B: Study treatment initiation at recurrence | Experimental | Drug: TG4050TG4050 treatment initiation at the time of recurrence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed written informed consent
- Newly diagnosed stage III or IV, amenable to surgery (AJCC 8th edition) squamous-cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
- Female or male patients, aged at least 18 years
- Patients in Complete Response after treatment of their primary tumor.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Key exclusion criteria (9 listed)
- 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.
- 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.
- Other active malignancy requiring concurrent systemic intervention.
- Patients with previous malignancies other than the target malignancy to be investigated in this trial
- Known history of positive testing for Human Immunodeficiency Virus (HIV) or known Acquired Immune Deficiency Syndrome (AIDS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TG4050Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks | Drug | Arm A : Early study treatment initiation, Arm B: Study treatment initiation at recurrence |
Primary outcome
Phase I: Safety and tolerability (Adverse Event reported per CTCAE v5)
Time frame: Up to 2 Years.
Incidence of Adverse Event reported per CTCAE v5.
Phase I/II: Disease-Free Survival
Time frame: Up to 2 years.
Time from randomization to documented recurrence of disease.
6 secondary outcomes
Phase I: Disease-Free Survival
Time frame: Up to 2 Years.
Phase I: Tumor response rate
Time frame: Up to 2 years.
Phase I/II: Safety and tolerability (Adverse Event reported per CTCAE v5)
Time frame: Up to 2 years.
Phase I/II: Distant Metastases-Free Survival
Time frame: Up to 2 years.
Phase I/II: Loco-Regional Relapse-Free Survival
Time frame: Up to 2 years.
Phase I/II: Overall Response Rate in patients with recurrent disease
Time frame: Up to 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Derived from this study: PubMed 42744798Ottensmeier C, Delord JP, Lalanne A, Jamet C, Le Gac AL, Bidet Huang K, Grellier B, Deforges J, Brandely M, Quemeneur E, Bastien B, Tavernaro A, Lacoste G, Schoettel V, Spring-Giusti C, Silvestre N, Marchand JB, Robin S, Dochy E, Ceppi M, Riva A, Yamagata N, Brattas P, Onoguchi K, Yamashita Y, Fontenelle H, Eggert Martinez M, Baker O, Jones T, Schache A, Piaggio E, Bendjama K, Lantz O, Le Tourneau C. A viral-based individualized neoantigen vaccine as adjuvant treatment in resected head and neck squamous cell carcinoma: a randomized Phase I trial. Nat Commun. 2026 Aug 17;17(1):9863. doi: 10.1038/s41467-026-76667-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TG4050 in people with Squamous Cell Carcinoma of Head and Neck, run by Transgene at 14 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain, France, United Kingdom, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Safety and tolerability (Adverse Event reported per CTCAE v5) (time frame: Up to 2 Years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04183166, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.