Phase 2 Study of Tiragolumab and Atezolizumab Before and After Surgery for Stage 3-4 Oral Cavity Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05681039

Provider View

This clinical trial is testing whether the combination of tiragolumab and atezolizumab, given before and after surgery and standard treatments, can help control oral cavity cancer that is PD-L1 CPS positive.

Patient Parameters

Program Overview

The study aims to find out if using tiragolumab and atezolizumab before and after surgery, along with standard treatments like radiation and chemotherapy, can better manage oral cavity squamous cell carcinoma (OCSCC) that is PD-L1 CPS positive. Researchers will look at how well the treatment works, its safety, and how it affects the cancer and patients' survival over time.

Description

This study is focused on patients with newly diagnosed, advanced oral cavity squamous cell carcinoma (OCSCC) that is PD-L1 CPS positive. The main goal is to see if two cycles of the drugs tiragolumab and atezolizumab, given before surgery, can significantly reduce the amount of cancer in the surgical specimen. Researchers will also assess the safety of these drugs and their overall effectiveness in shrinking tumors.

Secondary goals include evaluating the safety of the treatment, the overall response rate, and the percentage of cancer cells remaining after treatment. The study will also track how long patients live without the cancer getting worse and their overall survival.

Exploratory research will look at changes in the cancer environment and genetic profiles before and after treatment, as well as the activity of certain immune cells in the blood. Researchers will also assess the severity of symptoms and their link to treatment response.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a confirmed diagnosis of stage 3-4 oral cavity squamous cell carcinoma (OCSCC).
  • Cancer must be PD-L1 CPS positive.
  • Must have measurable disease.
  • Must be able to provide a tumor sample for research.
  • Must have good overall health and organ function.
  • Must agree to use effective contraception during and after the study if of childbearing potential.
  • Must not have active infections like HIV or hepatitis unless well-controlled.
  • Must not have had prior treatment for head and neck cancer that included radiation.
  • Must be able to comply with study requirements and provide informed consent.

Exclusion Criteria

  • Positive COVID-19 test within two weeks of starting the study.
  • Uncontrolled high calcium levels in the blood.
  • History of autoimmune diseases or immune deficiencies, with some exceptions.
  • Active tuberculosis or significant heart disease.
  • Recent major surgery or severe infection.
  • Prior organ transplant or treatment with certain investigational therapies.
  • Use of live vaccines recently or during the study.
  • Current treatment with certain antiviral or immunosuppressive medications.
  • Severe allergies to study drugs or components.
  • Pregnant or breastfeeding women, or those planning to become pregnant during the study.

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