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).
M.D. Anderson Cancer Center
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.
Description
Primary Objectives: 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. Secondary Objectives: To evaluate the safety of two cycles of atezolizumab and tiragolumab in patients with newly diagnosed, local-regionally advanced OCSCC, as measured by the incidence, nature and severity of adverse events with severity measured by…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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' treat…
Interventions
- DrugTiragolumab
Given by IV (vein)
- DrugAtezolizumab
Given by IV (vein)
- BehavioralStandard of Care
after care from surgery
- BehavioralQuestionnaires
Quality of life
- RadiationCisplatin
Given by IV (vein)
- RadiationCarboplatin
Given by IV (vein)
Location
- M D Anderson Cancer CenterHouston, Texas