Description:
This is a multicenter, open-label, two arms, randomized, phase I 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).
Title
- Brief Title: A Clinical Trial Evaluating TG4050 in Head and Neck Cancer
- Official Title: A Randomized Phase I Trial in Patients With Newly Diagnosed, Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Evaluating a Mutanome-directed Immunotherapy.
Clinical Trial IDs
- ORG STUDY ID:
TG4050.02
- NCT ID:
NCT04183166
Conditions
- Squamous Cell Carcinoma of Head and Neck
Interventions
Drug | Synonyms | Arms |
---|
TG4050 | | Arm A : Early study treatment initiation |
Purpose
This is a multicenter, open-label, two arms, randomized, phase I 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).
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A : Early study treatment initiation | Experimental | TG4050 treatment initiation at completion of primary treatment | |
Arm B: Study treatment initiation at recurrence | Experimental | TG4050 treatment initiation at the time of recurrence | |
Eligibility Criteria
Inclusion Criteria:
1. Signed written informed consent
2. Newly diagnosed stage III or IVA 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 cancer immunotherapy including anti-cancer vaccines, 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 within 30 days prior to TG4050 treatment
initiation
9. Uncontrolled intercurrent illness
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Safety and tolerability (Adverse Event reported per CTCAE v5) |
Time Frame: | Up to 2 Years. |
Safety Issue: | |
Description: | Incidence of Adverse Event reported per CTCAE v5 |
Secondary Outcome Measures
Measure: | Event-Free Survival duration |
Time Frame: | Up to 2 Years. |
Safety Issue: | |
Description: | Time from documented Complete Response after primary treatment to date of first recurrence |
Measure: | Tumor response rate |
Time Frame: | Up to 2 years. |
Safety Issue: | |
Description: | Percentage of patients whose best overall response is either a Complete Response or a Partial Response according to RECIST version 1.1 criteria. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Transgene |
Last Updated
June 3, 2021