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).
Part of paid clinical trials in Houston, Texas.
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT05681039
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- Oral Cavity Squamous Cell Carcinoma
- Squamous Cell Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Tiragolumab — DRUGGiven by IV (vein)
- Atezolizumab — DRUGGiven by IV (vein)
- Standard of Care — BEHAVIORALafter care from surgery
- Questionnaires — BEHAVIORALQuality of life
- Cisplatin — RADIATIONGiven by IV (vein)
- Carboplatin — RADIATIONGiven by IV (vein)
Study Details
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.
Key Dates
- Start date
- Jun 2, 2023
- Status verified
- Feb 2026
- Primary completion
- Nov 1, 2026
- Completion
- Nov 1, 2026
Study Design
- Enrollment
- 29 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Neoadjuvant and Adjuvant
Primary Outcome Measure
The major pathological response rate after neoadjuvant atezolizumab and tiragolumab. [ Time Frame: through study completion; an average of 1 year. ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | - |
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