A Clinical Trial Evaluating TG4050 in Head and Neck Cancer

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).

Study Overview

• Status: Recruiting
• Conditions: Squamous Cell Carcinoma of Head and Neck
• Intervention / Treatment: Drug: TG4050

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Transgene EU, Clinical Operations Department; Phone Number: + 33.3.88.27.91.00; Email: clinical.trials@transgene.fr

Study Locations

• France
  • Bordeaux, France, 33000
    • Not yet recruiting
    • Hopital Saint Andre - CHU de Bordeaux
    • Principal Investigator: Dr Daste
  • Marseille, France, 13000
    • Not yet recruiting
    • Hopital De La Timone
    • Principal Investigator: Pr Salas
  • Paris, France, 75005
    • Recruiting
    • Institut Curie
    • Principal Investigator: Pr Le Tourneau
  • Toulouse, France, 31100
    • Recruiting
    • IUCT Toulouse
    • Principal Investigator: Pr Delord
  • Villejuif, France, 94805
    • Not yet recruiting
    • Institut Gustave Roussy
    • Principal Investigator: Dr Even
• United Kingdom
  • Bebington, United Kingdom, CH63 4JY
    • Recruiting
    • NHS Clatterbridge Cancer Center
    • Principal Investigator: Pr Ottensmeier
  • Cardiff, United Kingdom, CF14 2TL
    • Not yet recruiting
    • Velindre Cancer Centre NHS Trust
    • Principal Investigator: Dr Evans
  • Liverpool, United Kingdom, L9 7AL
    • Recruiting
    • Aintree University Hospital NHS Fondation Trust
    • Principal Investigator: Pr Jones
  • Southampton, United Kingdom, SO16 6YD
    • Recruiting
    • University Hospital NHS Fondation Trust
    • Principal Investigator: Dr Karydis
• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic Jacksonville
      • Principal Investigator: Dr Zhao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A : Early study treatment initiation; TG4050 treatment initiation at completion of primary treatment	Drug: TG4050; Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks
Experimental: Arm B: Study treatment initiation at recurrence; TG4050 treatment initiation at the time of recurrence	Drug: TG4050; Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase I: Safety and tolerability (Adverse Event reported per CTCAE v5)	Incidence of Adverse Event reported per CTCAE v5.	Up to 2 Years.
Phase I/II: Disease-Free Survival	Time from randomization to documented recurrence of disease.	Up to 2 years.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Transgene

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2019
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: November 27, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: TG4050.02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No