Study on TG4050 for Head and Neck Cancer

Sponsor: Transgene

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04183166

Provider View

This clinical trial is testing the safety and effects of a new treatment called TG4050 in patients with head and neck cancer. The study involves patients with specific types of squamous cell carcinoma who have completed initial treatment and are in complete response.

Patient Parameters

Program Overview

This study is being conducted to evaluate a new treatment called TG4050 for patients with squamous cell carcinoma of the head and neck. The trial aims to assess how safe and tolerable the treatment is, as well as its effects on the cancer. It is open to adults who have been newly diagnosed with stage III or IV cancer in areas such as the oral cavity, oropharynx, hypopharynx, or larynx, and who have responded completely to their initial treatment.

Eligibility Criteria

Inclusion Criteria

  • Must provide signed consent to participate.
  • Have a new diagnosis of stage III or IV squamous cell carcinoma in specific areas of the head and neck, such as the mouth or throat, that can be treated with surgery.
  • Be 18 years or older.
  • Have no remaining signs of cancer after initial treatment.
  • Be in good overall health, with a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have adequate blood, liver, and kidney function as determined by medical tests.

Exclusion Criteria

  • Have cancer in the nasopharynx, skin, salivary glands, or paranasal sinuses, or have a type of cancer other than squamous cell carcinoma.
  • Have previously received cancer vaccines or treatments targeting specific immune proteins like PD1, PDL1, or CTLA4.
  • Have another active cancer that requires treatment.
  • Have had other cancers besides the one being studied in this trial.
  • Have a known history of HIV or AIDS.
  • Have a history or current infection with Hepatitis C or B.
  • Be pregnant or breastfeeding.
  • Have taken another experimental treatment recently.
  • Have any uncontrolled illnesses.

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