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A Clinical Trial Evaluating TG4050 in Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04183166
Recruitment Status : Recruiting
First Posted : December 3, 2019
Last Update Posted : April 22, 2024
Sponsor:
Information provided by (Responsible Party):
Transgene

Study Description
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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 Intervention/treatment Phase
Squamous Cell Carcinoma of Head and Neck Drug: TG4050 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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 : December 12, 2019
Estimated Primary Completion Date : December 30, 2027
Estimated Study Completion Date : December 30, 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Phase I: Safety and tolerability (Adverse Event reported per CTCAE v5) [ Time Frame: Up to 2 Years. ]
    Incidence of Adverse Event reported per CTCAE v5.

  2. Phase I/II: Disease-Free Survival [ Time Frame: Up to 2 years. ]
    Time from randomization to documented recurrence of disease.


Secondary Outcome Measures :
  1. Phase I: Disease-Free Survival [ Time Frame: Up to 2 Years. ]
    Time from randomization to documented recurrence of disease.

  2. Phase I: Tumor response rate [ Time Frame: 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.

  3. Phase I/II: Safety and tolerability (Adverse Event reported per CTCAE v5) [ Time Frame: Up to 2 years. ]
    Incidence of Adverse Event reported per CTCAE v5.

  4. Phase I/II: Distant Metastases-Free Survival [ Time Frame: Up to 2 years. ]
    Time from randomization to documented first occurrence of distant metastasis.

  5. Phase I/II: Loco-Regional Relapse-Free Survival [ Time Frame: Up to 2 years. ]
    Time from randomization to documented loco-regional recurrence.

  6. Phase I/II: Overall Response Rate in patients with recurrent disease [ Time Frame: Up to 2 years. ]
    Percentage of patients with a best overall response of complete response or partial response according to RECIST, version 1.1 criteria.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04183166


Contacts
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Contact: Transgene EU, Clinical Operations Department + 33.3.88.27.91.00 clinical.trials@transgene.fr

Locations
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United States, Florida
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Principal Investigator: Dr Zhao         
France
Hôpital Saint André - CHU de Bordeaux Not yet recruiting
Bordeaux, France, 33000
Principal Investigator: Dr Daste         
Hôpital de la Timone Not yet recruiting
Marseille, France, 13000
Principal Investigator: Pr Salas         
Institut Curie Recruiting
Paris, France, 75005
Principal Investigator: Pr Le Tourneau         
IUCT Toulouse Recruiting
Toulouse, France, 31100
Principal Investigator: Pr Delord         
Institut Gustave Roussy Not yet recruiting
Villejuif, France, 94805
Principal Investigator: Dr Even         
United Kingdom
NHS Clatterbridge Cancer Center Recruiting
Bebington, United Kingdom, CH63 4JY
Principal Investigator: Pr Ottensmeier         
Velindre Cancer Centre NHS Trust Not yet recruiting
Cardiff, United Kingdom, CF14 2TL
Principal Investigator: Dr Evans         
Aintree University Hospital NHS Fondation Trust Recruiting
Liverpool, United Kingdom, L9 7AL
Principal Investigator: Pr Jones         
University Hospital NHS Fondation Trust Recruiting
Southampton, United Kingdom, SO16 6YD
Principal Investigator: Dr Karydis         
Sponsors and Collaborators
Transgene
More Information
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Responsible Party: Transgene
ClinicalTrials.gov Identifier: NCT04183166    
Other Study ID Numbers: TG4050.02
First Posted: December 3, 2019    Key Record Dates
Last Update Posted: April 22, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site