A Clinical Trial Evaluating TG4050 in Head and Neck Cancer

Squamous Cell Carcinoma of Head and Neck Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04183166
• Other study ID #: TG4050.02
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 12, 2019
• Est. completion date: December 30, 2028

Study information

• Verified date: April 2024
• Source: Transgene
• Contact: Transgene EU, Clinical Operations Department
• Phone: + 33.3.88.27.91.00
• Email: clinical.trials[@]transgene.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 30, 2028
• Est. primary completion date: December 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• TG4050
Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks

Locations

Country	Name	City	State
France	Hôpital Saint André - CHU de Bordeaux	Bordeaux
France	Hôpital de la Timone	Marseille
France	Institut Curie	Paris
France	IUCT Toulouse	Toulouse
France	Institut Gustave Roussy	Villejuif
United Kingdom	NHS Clatterbridge Cancer Center	Bebington
United Kingdom	Velindre Cancer Centre NHS Trust	Cardiff
United Kingdom	Aintree University Hospital NHS Fondation Trust	Liverpool
United Kingdom	University Hospital NHS Fondation Trust	Southampton
United States	Mayo Clinic Jacksonville	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Transgene

Countries where clinical trial is conducted

United States,  France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I: Safety and tolerability (Adverse Event reported per CTCAE v5)	Incidence of Adverse Event reported per CTCAE v5.	Up to 2 Years.
Primary	Phase I/II: Disease-Free Survival	Time from randomization to documented recurrence of disease.	Up to 2 years.
Secondary	Phase I: Disease-Free Survival	Time from randomization to documented recurrence of disease.	Up to 2 Years.
Secondary	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.	Up to 2 years.
Secondary	Phase I/II: Safety and tolerability (Adverse Event reported per CTCAE v5)	Incidence of Adverse Event reported per CTCAE v5.	Up to 2 years.
Secondary	Phase I/II: Distant Metastases-Free Survival	Time from randomization to documented first occurrence of distant metastasis.	Up to 2 years.
Secondary	Phase I/II: Loco-Regional Relapse-Free Survival	Time from randomization to documented loco-regional recurrence.	Up to 2 years.
Secondary	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.	Up to 2 years.