RecruitingPhase 2NCT05681039

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).


Sponsor

M.D. Anderson Cancer Center

Enrollment

29 participants

Start Date

Jun 2, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing two immunotherapy drugs — tiragolumab and atezolizumab — given before and after surgery in patients with newly diagnosed, surgically removable oral cavity cancer (mouth cancer) that tests positive for a marker called PD-L1. The goal is to see if immunotherapy can shrink the cancer before surgery and prevent it from coming back afterward. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with Stage 3 or 4 oral cavity squamous cell carcinoma that can be surgically removed - Your tumor tests positive for PD-L1 (a protein marker) - You are in good overall health (ECOG 0–1) - Your blood counts and organ function meet the required levels **You may NOT be eligible if...** - You have an active autoimmune disease (other than well-controlled thyroid conditions, type 1 diabetes, or mild skin conditions) - You have had a lung inflammation condition requiring steroids - You have had a prior head and neck cancer treatment including in-field radiation - You have had a severe COVID-19 infection recently - You are pregnant or breastfeeding - You have previously received immunotherapy drugs for cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT05681039


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