What side effects are associated with this type of intervention?

Common treatments for Squamous Cell Carcinoma (SCC) using immune checkpoint inhibitors like Atezolizumab (Anti-PD-L1 Antibody) and Tiragolumab (Anti-TIGIT Antibody) can lead to several side effects. These include immune-related adverse events such as rash, pruritus, diarrhea, and hypothyroidism. More severe reactions can include pneumonitis, hepatitis, colitis, and endocrinopathies. Additionally, combining these treatments with other therapies may increase the risk of liver toxicity and other grade 3/4 adverse events. Patients should be closely monitored for these side effects to manage them promptly.

What prior FDA approvals exist?

For the treatment of Squamous Cell Carcinoma, the FDA has approved several immune checkpoint inhibitors. Pembrolizumab (Keytruda), an anti-PD-1 antibody, has been approved for use in various squamous cell carcinomas, including head and neck squamous cell carcinoma (HNSCC) and esophageal squamous cell carcinoma (ESCC). Atezolizumab (Tecentriq), an anti-PD-L1 antibody, has also been approved for use in non-small cell lung cancer (NSCLC) with squamous histology. These approvals are based on clinical trials demonstrating improved overall survival and progression-free survival in patients treated with these agents compared to traditional chemotherapy.

What other types of research exist?

Promising alternatives to Tiragolumab and Atezolizumab for SCC patients include: 1) Pembrolizumab (anti-PD-1 antibody), which has shown efficacy in SCC of the esophagus with high PD-L1 expression. 2) Nivolumab (anti-PD-1 antibody), which has demonstrated improved overall survival in previously treated advanced esophageal SCC. 3) Elraglusib (GSK-3 beta inhibitor), which reduces expression of immune checkpoint molecules PD-1, TIGIT, and LAG-3, potentially enhancing the efficacy of existing immunotherapies.

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Monoclonal Antibodies

Tiragolumab + Atezolizumab for Oral Cancer

Phase 2

Recruiting

Led By Maura Gillison

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two drugs, tiragolumab and atezolizumab, in patients with advanced oral cancer. These drugs are given before and after standard treatments to help the immune system fight the cancer more effectively.

Who is the study for?

Adults with newly diagnosed, PD-L1 CPS positive, resectable Stage 3-4 Oral Cavity Squamous Cell Carcinoma (OCSCC) who are in good physical condition (ECOG 0-1), have measurable disease per RECIST v1.1, and can comply with the study protocol. Excluded are those with prior significant treatments or conditions that could interfere with the trial, such as autoimmune diseases, recent infections including COVID-19, or allergies to trial medications.

What is being tested?

The effectiveness of Tiragolumab plus Atezolizumab before and after surgery and chemoradiation is being tested against OCSCC. The goal is to see if these drugs can better control cancer when added to standard treatment which may include radiation therapy alongside chemotherapy agents like Cisplatin or Carboplatin.

What are the potential side effects?

Potential side effects include immune-related reactions affecting different organs, infusion-related responses similar to allergic reactions, tiredness, gastrointestinal issues like nausea or diarrhea, blood cell count changes increasing infection risk. Individual experiences may vary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The major pathological response rate after neoadjuvant atezolizumab and tiragolumab.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Neoadjuvant and AdjuvantExperimental Treatment6 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tiragolumab

2019

Completed Phase 3

~2330

Atezolizumab

2016

Completed Phase 3

~5860

Standard of Care

2017

Completed Phase 4

~4420

Questionnaires

2013

Completed Phase 2

~4280

Cisplatin

2013

Completed Phase 3

~3120

Carboplatin

2014

Completed Phase 3

~6120

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Squamous Cell Carcinoma (SCC) include immune checkpoint inhibitors like Tiragolumab and Atezolizumab. Tiragolumab targets TIGIT, a protein that suppresses immune responses, thereby enhancing the activity of T-cells against cancer cells. Atezolizumab targets PD-L1, a protein that helps cancer cells evade the immune system. By inhibiting PD-L1, Atezolizumab restores the immune system's ability to recognize and destroy cancer cells. These mechanisms are significant for SCC patients as they offer a way to boost the body's natural defenses against cancer, potentially leading to improved survival rates and better overall outcomes.

Programmed cell death 1 protein and programmed death-ligand 1 inhibitors in the treatment of nonmelanoma skin cancer: A systematic review.