Clinical trial NCT04183166: A Clinical Trial Evaluating TG4050 in Head and Neck Cancer
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.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Squamous Cell Carcinoma of Head and Neck
Lead sponsor: Transgene
Sponsor class: INDUSTRY
First posted: 2019-12-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Phase I: Safety and tolerability (Adverse Event reported per CTCAE v5)
timeFrame: Up to 2 Years.
measure: Phase I/II: Disease-Free Survival
timeFrame: Up to 2 years.
Secondary outcomes:
measure: Phase I: Disease-Free Survival
timeFrame: Up to 2 Years.
measure: Phase I: Tumor response rate
timeFrame: Up to 2 years.
measure: Phase I/II: Safety and tolerability (Adverse Event reported per CTCAE v5)
timeFrame: Up to 2 years.
measure: Phase I/II: Distant Metastases-Free Survival
timeFrame: Up to 2 years.
measure: Phase I/II: Loco-Regional Relapse-Free Survival
timeFrame: Up to 2 years.
measure: Phase I/II: Overall Response Rate in patients with recurrent disease
timeFrame: Up to 2 years.
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Bordeaux
country: France
facility: Hôpital Saint André - CHU de Bordeaux
city: Marseille
country: France
facility: Hôpital de la Timone
city: Paris
country: France
facility: Institut Curie
city: Toulouse
country: France
facility: IUCT Toulouse
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d Hebrón
city: Barcelona
country: Spain
facility: Institut Català d Oncologia - Hospital Duran i Reynals
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga - Hospital Civil
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
city: Liverpool
country: United Kingdom
facility: NHS Clatterbridge Cancer Center
city: Liverpool
country: United Kingdom
facility: Aintree University Hospital NHS Fondation Trust
Study officials:
References: