Study on Toripalimab with Standard Treatment for HPV Positive Throat Cancer

Sponsor: University of Chicago

Sponsor score: 0

ClinicalTrials ID:NCT07290621

This clinical trial is testing how well the drug toripalimab works when combined with chemotherapy and followed by surgery or adjusted radiation therapy in patients with advanced HPV16-positive throat cancer.

Patient Parameters

Program Overview

This study aims to find out if combining the drug toripalimab with chemotherapy, followed by surgery or tailored radiation therapy, can effectively treat patients with advanced HPV16-positive throat cancer. The trial is focused on patients whose cancer is located in the oropharynx and is at an advanced stage.

Eligibility Criteria

Inclusion Criteria

  • Must have confirmed HPV16-positive throat cancer.
  • Cancer must be located in the oropharynx, but other rare HPV-positive sites may also qualify.
  • Must be 18 years or older.
  • Cancer must be at a specific advanced stage, with certain tumor sizes or lymph node involvement.
  • Must have measurable cancer that can be tracked by scans.
  • No previous radiation or chemotherapy for head and neck cancer.
  • No major surgery for head and neck cancer within 8 weeks before joining the study.
  • Must be in good overall health with a performance status of 0 or 1.
  • Must be eligible to receive the chemotherapy drug cisplatin.
  • Must sign an informed consent form and understand the study.
  • Women must not be pregnant or breastfeeding and must use effective birth control.
  • Men must use effective birth control if sexually active with women who can become pregnant.

Exclusion Criteria

  • Cancer has spread to distant parts of the body.
  • Cancer is not HPV16 subtype.
  • Primary cancer site cannot be identified.
  • Have serious medical conditions that affect treatment tolerance or survival.
  • Have low-risk N1 disease (small single lymph node).
  • Have active autoimmune or inflammatory disorders needing immunosuppressive therapy, except for certain stable conditions.
  • Have used immunosuppressive medications recently, except for specific low-dose treatments.
  • Have had severe allergic reactions to similar treatments.
  • Are using herbal remedies that affect the immune system or organ function.
  • Have had major surgery other than minor biopsies or tumor-reducing procedures.
  • Are receiving other experimental treatments.
  • Have had recent systemic cancer treatment.
  • Have another progressing or actively treated cancer, except for certain skin cancers or in situ cervical cancer.
  • Have active lung inflammation not caused by infection.
  • Have active Hepatitis B or C, unless eradicated.
  • Have received a live vaccine recently.

Locations

FACILITYZIPCITYSTATE
The University of Chicago Medicine Comprehensive Cancer Center60637ChicagoIllinois

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