A Clinical Trial Evaluating TG4050 in Head and Neck Cancer

Sponsor

Transgene (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04183166

Collaborator

(none)

Enrollment

Locations

Arms

59.6

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Squamous Cell Carcinoma of Head and Neck	Drug: TG4050	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Dec 12, 2019

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Nov 30, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Safety and tolerability (Adverse Event reported per CTCAE v5) [Up to 2 Years.]
Incidence of Adverse Event reported per CTCAE v5

Secondary Outcome Measures

Event-Free Survival duration [Up to 2 Years.]
Time from documented Complete Response after primary treatment to date of first recurrence
Tumor response rate [Up to 2 years.]
Percentage of patients whose best overall response is either a Complete Response or a Partial Response according to RECIST version 1.1 criteria.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Signed written informed consent
Newly diagnosed stage III or IVA squamous-cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
Female or male patients, aged at least 18 years
Patients in Complete Response after treatment of their primary tumor.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Adequate hematological, hepatic and renal functions

Exclusion Criteria:

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.
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.
Other active malignancy requiring concurrent systemic intervention.
Patients with previous malignancies other than the target malignancy to be investigated in this trial
Known history of positive testing for Human Immunodeficiency Virus (HIV) or known Acquired Immune Deficiency Syndrome (AIDS)
Clinical or laboratory history or evidence of Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) indicating acute or chronic infection
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)
Treatment with another investigational agent within 30 days prior to TG4050 treatment initiation
Uncontrolled intercurrent illness

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Jacksonville	Jacksonville	Florida	United States	32224
2	Institut Curie	Paris		France	75005
3	IUCT Toulouse	Toulouse		France	31100
4	NHS Clatterbridge Cancer Center	Bebington		United Kingdom	CH63 4JY
5	Aintree University Hospital NHS Fondation Trust	Liverpool		United Kingdom	L9 7AL
6	University Hospital NHS Fondation Trust	Southampton		United Kingdom	SO16 6YD

Sponsors and Collaborators

Transgene

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Transgene

ClinicalTrials.gov Identifier:

NCT04183166

Other Study ID Numbers:

TG4050.02

First Posted:

Dec 3, 2019

Last Update Posted:

Nov 8, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Study Results

No Results Posted as of Nov 8, 2021