Actively Recruiting
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).
Led by M.D. Anderson Cancer Center · Updated on 2026-05-05
29
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age 18 years or older at time of consent
- Able to comply with study procedures as judged by investigator
- Newly diagnosed oral cavity squamous cell carcinoma, clinical stage 3-4 (T1-T4N1-3, T3-T4N0)
- Patients with prior resected stage T1N0 or T2N0 OCSCC and no prior head and neck radiotherapy eligible if recurrence meets criteria
- Surgically resectable tumor as determined by surgeon
- Measurable disease by RECIST v1.1
- Tumor PD-L1 CPS score of 1 or higher
- Availability of tumor specimen for biomarker research
- ECOG performance status 0-1
- Adequate blood counts and organ function within 14 days before treatment
- Negative HIV, hepatitis B and C tests with exceptions for stable treated cases
- For women of childbearing potential: agreement to use effective contraception or abstinence during treatment and specified follow-up periods
- For men: agreement to use contraception or abstinence during treatment and specified follow-up periods
You will not qualify if you...
- Positive SARS-CoV-2 test within 2 weeks before enrollment
- Uncontrolled or symptomatic high calcium levels
- Active or history of autoimmune or immune deficiency diseases with specific exceptions
- History of certain lung diseases or active pneumonitis
- Active tuberculosis
- Significant cardiovascular disease within 3 months before treatment
- Major surgery within 4 weeks before treatment or planned during study
- History of malignancy within 5 years except low-risk cancers
- Severe infection including recent SARS-CoV-2 or ongoing infections
- Recent therapeutic antibiotics within 2 weeks before treatment
- Prior allogeneic stem cell or organ transplant
- Any condition increasing risk from investigational drugs or affecting study results
- Recent live vaccine use or planned during study
- Current antiviral treatment for hepatitis B
- Positive Epstein-Barr virus IgM or PCR test
- Prior head and neck cancer treatment including radiotherapy
- Recent investigational therapy within 42 days before treatment
- Prior treatment with certain immune therapies
- Recent systemic immunostimulatory or immunosuppressive treatments with exceptions
- History of severe allergic reactions to antibodies
- Known allergy to study drugs or chemotherapy components
- Pregnant or breastfeeding women or intent to become pregnant during and after treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
L
Luana Guimaraes De Sousa, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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