Thinking of joining a study?

Register your interest

Become a volunteer?

NCT04183166 | RECRUITING | Squamous Cell Carcinoma of Head and Neck

A Clinical Trial Evaluating TG4050 in Head and Neck Cancer
Sponsor:

Transgene

Brief 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).

Condition or disease

Squamous Cell Carcinoma of Head and Neck

Intervention/treatment

TG4050

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 80 participants
Masking : NONE
Primary Purpose : TREATMENT
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.
Actual Study Start Date : 2019-12-12
Estimated Primary Completion Date : 2027-12-30
Estimated Study Completion Date : 2028-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
A Clinical Trial Evaluating TG4050 in Head and Neck Cancer

Location Details

NCT04183166

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

Mayo Clinic Jacksonville

Jacksonville, Florida, United States, 32224

RECRUITING

France,

Saint André Hospital - CHU de Bordeaux

Bordeaux, France, 33000

RECRUITING

France,

Timone Hospital

Marseille, France, 13000

RECRUITING

France,

Curie Institute

Paris, France, 75005

RECRUITING

France,

IUCT Toulouse

Toulouse, France, 31100

RECRUITING

France,

Gustave Roussy Institute

Villejuif, France, 94805

RECRUITING

Spain,

Vall d'Hebron University Hospital

Barcelona, Spain, 08035

NOT YET RECRUITING

Spain,

Catalan Institute of Oncology - Hospital Duran i Reynals

Barcelona, Spain, 08908

RECRUITING

Spain,

San Carlos Clinical Hospital

Madrid, Spain, 28040

RECRUITING

Spain,

La Paz University Hospital

Madrid, Spain, 28046

RECRUITING

Spain,

Regional University Hospital of Malaga - Civil Hospital

Málaga, Spain, 29010

NOT YET RECRUITING

Spain,

Santiago University Hospital Complex

Santiago de Compostela, Spain, 15076

RECRUITING

United Kingdom,

NHS Clatterbridge Cancer Center

Liverpool, United Kingdom, Tail

RECRUITING

United Kingdom,

Aintree University Hospital NHS Fondation Trust

Liverpool, United Kingdom, Thief