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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 : January 10, 2020
Sponsor:
Information provided by (Responsible Party):
Transgene

Tracking Information
First Submitted Date  ICMJE November 21, 2019
First Posted Date  ICMJE December 3, 2019
Last Update Posted Date January 10, 2020
Actual Study Start Date  ICMJE December 12, 2019
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2019)
Safety and tolerability (Adverse Event reported per CTCAE v5) [ Time Frame: Up to 2 Years. ]
Incidence of Adverse Event reported per CTCAE v5
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2019)
  • Event-Free Survival duration [ Time Frame: Up to 2 Years. ]
    Time from documented Complete Response after primary treatment to date of first recurrence
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial Evaluating TG4050 in Head and Neck Cancer
Official Title  ICMJE 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.
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Squamous Cell Carcinoma of Head and Neck
Intervention  ICMJE Drug: TG4050
Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks
Study Arms  ICMJE
  • Experimental: Arm A : Early study treatment initiation
    TG4050 treatment initiation at completion of primary treatment
    Intervention: Drug: TG4050
  • Experimental: Arm B: Study treatment initiation at recurrence
    TG4050 treatment initiation at the time of recurrence
    Intervention: Drug: TG4050
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 27, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2022
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Transgene EU, Clinical Operations Department + 33.3.88.27.91.00 clinical.trials@transgene.fr
Listed Location Countries  ICMJE France,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04183166
Other Study ID Numbers  ICMJE TG4050.02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Transgene
Study Sponsor  ICMJE Transgene
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Transgene
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP