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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tiragolumab — DRUG
    Given by IV (vein)
  • Atezolizumab — DRUG
    Given by IV (vein)
  • Standard of Care — BEHAVIORAL
    after care from surgery
  • Questionnaires — BEHAVIORAL
    Quality of life
  • Cisplatin — RADIATION
    Given by IV (vein)
  • Carboplatin — RADIATION
    Given 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)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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