Phase 2 Trial of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab in Patients With Newly Diagnosed PD-L1 CPS Positive Resectable Stage 3-4 Oral Cavity Squamous Cell Carcinoma (OCSCC).

NCT05681039 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2022-0446NCI-2022-10637
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

To learn if treatment with tiragolumab and atezolizumab before and after standard of care surgery and chemoradiation (radiation therapy with or without cisplatin/carboplatin) can help to control OCSCC that is PD-L1 CPS positive.

Conditions

Squamous Cell Carcinoma; Oral Cavity Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• The major pathological response rate after neoadjuvant atezolizumab and tiragolumab.

  To determine the major pathological response rate, defined as \<10% viable tumor in the resection specimen, after two cycles of neoadjuvant atezolizumab and tiragolumab in patients with newly diagnosed, local-regionally advanced OCSCC that is PD-L1 CPS ≥1. Response at the primary site and in nodal disease will be evaluated

  through study completion; an average of 1 year.

Study Arms (1)

Neoadjuvant and Adjuvant

EXPERIMENTAL

Drug: Tiragolumab; Drug: Atezolizumab; Behavioral: Standard of Care; Behavioral: Questionnaires; Radiation: Cisplatin; Radiation: Carboplatin

Interventions

Tiragolumab DRUG

Given by IV (vein)

Neoadjuvant and Adjuvant

Atezolizumab DRUG

Given by IV (vein)

Also known as: MPDL3280A, TECENTRIQ

Neoadjuvant and Adjuvant

Standard of Care BEHAVIORAL

after care from surgery

Neoadjuvant and Adjuvant

Questionnaires BEHAVIORAL

Quality of life

Neoadjuvant and Adjuvant

Cisplatin RADIATION

Given by IV (vein)

Neoadjuvant and Adjuvant

Carboplatin RADIATION

Given by IV (vein)

Neoadjuvant and Adjuvant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form
• Age 18 years at time of signing Informed Consent Form
• Ability to comply with the study protocol, in the investigator's judgment
• Histologically or cytologically confirmed, newly diagnosed, OCSCC that is clinical AJCC 8th edition Stage 3-4 (T1-T4N1-3, T3-T4N0)
• Patients with a history of previously resected stage T1N0 or T2N0 OCSCC and no prior history of radiotherapy to the head and neck are eligible at local +/- regional recurrence if they otherwise meet stage criteria.
• Surgically resectable OCSCC as determined by the patients' treating head and neck surgeon. Patients with a clinical diagnosis of oral cavity cancer, awaiting a biopsy are eligible to consent for pre-screening.
• Measurable disease per RECIST v1.1
• PD-L1 CPS≥ 1 (determined by immunohistochemistry with the 22C3 antibody) as documented through testing of a representative tumor tissue specimen
• Availability of a representative tumor specimen for exploratory biomarker research (see Appendix 12 for information on tumor specimens) A formalin-fixed paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or at least 15 slides containing unstained, freshly cut, serial sections must be available for baseline biomarker analysis along with an associated pathology report prior to study enrollment. If archival tumor tissue is unavailable or is determined to be unsuitable for, tumor tissue must be obtained from a biopsy performed at screening.
• ECOG Performance Status of 0-1
• Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
• ANC 1.5 109/L (1500/L) without granulocyte colony-stimulating factor support
• Lymphocyte count 0.5 109/L (500/L)
• Platelet count 100 109/L (100,000/L) without transfusion
• Hemoglobin 90 g/L (9 g/dL) Patients may be transfused to meet this criterion.

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from study entry:
• Positive test for SARS-CoV-2 within two weeks of enrollment.
• Uncontrolled or symptomatic hypercalcemia (ionized calcium 1.5 mmol/L, calcium 12 mg/dL or corrected serum calcium ULN)
• Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis (see Appendix 6 for a more comprehensive list of autoimmune diseases and immune deficiencies), with the following exceptions:
• Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
• Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
• Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
• Rash must cover 10% of body surface area
• Disease is well controlled at baseline and requires only low-potency topical corticosteroids
• No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
• Active tuberculosis
• Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
• Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
• History of malignancy within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \> 90%), such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck

Interventions

Tiragolumab; atezolizumab; Standard of Care; Surveys and Questionnaires; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• Luana Guimaraes De Sousa, MD PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luana Guimaraes De Sousa, MD PhD

CONTACT

832-728-7849; LGSousa@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: January 11, 2023
• Study Start: June 2, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-02

Locations

US (1)