OncoMatch/Clinical Trials/NCT05681039
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).
Is NCT05681039 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Tiragolumab and Atezolizumab for squamous cell carcinoma.
Treatment: Tiragolumab · Atezolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: PD-L1 (CD274) cps ≥ 1 (cps ≥ 1)
Disease stage
Required: Stage III, IV, T1-T4N1-3, T3-T4N0 (AJCC 8th edition)
Excluded: Stage T1N0, T2N0
clinical AJCC 8th edition Stage 3-4 (T1-T4N1-3, T3-T4N0)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiotherapy
Exception: no prior history of radiotherapy to the head and neck for patients with previously resected stage T1N0 or T2N0 OCSCC
no prior history of radiotherapy to the head and neck are eligible at local +/- regional recurrence if they otherwise meet stage criteria
Cannot have received: in-field radiotherapy for head and neck cancer
Prior treatment for head and neck cancer that includes in field radiotherapy
Cannot have received: CD137 agonist
Prior treatment with CD137 agonists
Cannot have received: immune checkpoint blockade therapy (anti-CTLA-4, anti-PD-1, anti-PD-L1)
Prior treatment with ... immune checkpoint blockade therapies, including antiCTLA-4, anti PD-1, and anti PD-L1 therapeutic antibodies
Cannot have received: investigational therapy
Treatment with investigational therapy within 42 days prior to initiation of study treatment
Cannot have received: systemic immunostimulatory agent (interferon, interleukin 2)
Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L (1500/μL) without G-CSF; lymphocyte count ≥ 0.5 x 10^9/L (500/μL); platelet count ≥ 100 x 10^9/L (100,000/μL) without transfusion; hemoglobin ≥ 90 g/L (9 g/dL), may be transfused
Kidney function
Creatinine clearance ≥ 50 mL/min (Cockcroft-Gault)
Liver function
AST, ALT, and alkaline phosphatase (ALP) ≤ 2.5 x ULN; serum bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for Gilbert disease)
Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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