ACTIVE_NOT_RECRUITING

A Clinical Trial Evaluating TG4050 in Head and Neck Cancer

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Conditions

Squamous Cell Carcinoma of Head and Neck

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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.

Quick Facts

Study Start:2019-12-12
Study Completion:2028-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04183166

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Signed written informed consent
  2. 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. 3. Female or male patients, aged at least 18 years
  4. 4. Patients in Complete Response after treatment of their primary tumor.
  5. 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  6. 6. Adequate hematological, hepatic and renal functions
  1. 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. 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. 3. Other active malignancy requiring concurrent systemic intervention.
  4. 4. Patients with previous malignancies other than the target malignancy to be investigated in this trial
  5. 5. Known history of positive testing for Human Immunodeficiency Virus (HIV) or known Acquired Immune Deficiency Syndrome (AIDS)
  6. 6. Clinical or laboratory history or evidence of Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) indicating acute or chronic infection
  7. 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. 8. Treatment with another investigational agent since the beginning of the screening period
  9. 9. Uncontrolled intercurrent illness

Contacts and Locations

Study Locations (Sites)

Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
United States

Collaborators and Investigators

Sponsor: Transgene

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-12
Study Completion Date2028-12-30

Study Record Updates

Study Start Date2019-12-12
Study Completion Date2028-12-30

Terms related to this study

Additional Relevant MeSH Terms

  • Squamous Cell Carcinoma of Head and Neck