Back to results

A Clinical Trial Evaluating TG4050 in Head and Neck Cancer

Primary Purpose

Squamous Cell Carcinoma of Head and Neck

Status

Recruiting

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

TG4050

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Mayo Clinic JacksonvilleRecruiting
Institut CurieRecruiting
IUCT ToulouseRecruiting
NHS Clatterbridge Cancer CenterRecruiting
Aintree University Hospital NHS Fondation TrustRecruiting
University Hospital NHS Fondation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm A : Early study treatment initiation

Arm B: Study treatment initiation at recurrence

Arm Description

TG4050 treatment initiation at completion of primary treatment

TG4050 treatment initiation at the time of recurrence

Outcomes

Primary Outcome Measures

Safety and tolerability (Adverse Event reported per CTCAE v5)

Incidence of Adverse Event reported per CTCAE v5

Secondary Outcome Measures

Event-Free Survival duration

Time from documented Complete Response after primary treatment to date of first recurrence

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.

Full Information

NCT ID

NCT04183166

First Posted

November 21, 2019

Last Updated

November 5, 2021

Sponsor

Transgene

1. Study Identification

Unique Protocol Identification Number

NCT04183166

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.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

December 12, 2019 (Actual)

Primary Completion Date

November 30, 2023 (Anticipated)

Study Completion Date

November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Transgene

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Squamous Cell Carcinoma of Head and Neck

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A : Early study treatment initiation

Arm Type

Experimental

Arm Description

TG4050 treatment initiation at completion of primary treatment

Arm Title

Arm B: Study treatment initiation at recurrence

Arm Type

Experimental

Arm Description

TG4050 treatment initiation at the time of recurrence

Intervention Type

Drug

Intervention Name(s)

TG4050

Intervention Description

Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks

Primary Outcome Measure Information:

Title

Safety and tolerability (Adverse Event reported per CTCAE v5)

Description

Incidence of Adverse Event reported per CTCAE v5

Time Frame

Up to 2 Years.

Secondary Outcome Measure Information:

Title

Event-Free Survival duration

Description

Time from documented Complete Response after primary treatment to date of first recurrence

Time Frame

Up to 2 Years.

Title

Tumor response rate

Description

Percentage of patients whose best overall response is either a Complete Response or a Partial Response according to RECIST version 1.1 criteria.

Time Frame

Up to 2 years.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Transgene EU, Clinical Operations Department

Phone

+ 33.3.88.27.91.00

clinical.trials@transgene.fr

Facility Information:

Facility Name

Mayo Clinic Jacksonville

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dr Zhao

Facility Name

Institut Curie

City

Paris

ZIP/Postal Code

75005

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pr Le Tourneau

Facility Name

IUCT Toulouse

City

Toulouse

ZIP/Postal Code

31100

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pr Delord

Facility Name

NHS Clatterbridge Cancer Center

City

Bebington

ZIP/Postal Code

CH63 4JY

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dr Sacco

First Name & Middle Initial & Last Name & Degree

Pr Ottensmeier

Facility Name

Aintree University Hospital NHS Fondation Trust

City

Liverpool

ZIP/Postal Code

L9 7AL

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pr Jones

Facility Name

University Hospital NHS Fondation Trust

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dr Karydis

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Clinical Trial Evaluating TG4050 in Head and Neck Cancer

We'll reach out to this number within 24 hrs