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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
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.
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.
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
~1400
Atezolizumab
2017
Completed Phase 3
~5850
Standard of Care
2017
Completed Phase 4
~4420
Questionnaires
2013
Completed Phase 2
~3330
Cisplatin
2013
Completed Phase 3
~2360
Carboplatin
2014
Completed Phase 3
~6120
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.
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Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,672 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,550 Previous Clinical Trials
568,335 Total Patients Enrolled
Maura GillisonPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
48 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had cancer within the last 5 years.My blood and organs are functioning well.I haven't had major surgery in the last 4 weeks.I have not taken any strong antibiotics in the last 2 weeks.I have high calcium levels in my blood that are causing symptoms.I have or had an autoimmune disease or immune deficiency.I have a history of lung scarring or inflammation not caused by infections.My oral cancer is confirmed and is at an advanced stage.My cancer has a PD-L1 score of 1 or higher.I have active tuberculosis.I have not received a live vaccine in the last 4 weeks.My surgeon says my oral cancer can be removed with surgery.I tested positive for a recent Epstein-Barr virus infection.I am allergic to some chemotherapy drugs.I am at least 18 years old.I am fully active or can carry out light work.I have previously been treated with CD137 agonists or immune checkpoint inhibitors.I agree to either not have sex or use birth control, and not to donate sperm.I have not had serious heart problems in the last 3 months.I have not had a severe infection in the last 4 weeks.I don't have any health issues that prevent me from taking new medications.I am currently taking medication that suppresses my immune system.I had early-stage oral cancer surgery without head/neck radiation and it's come back.I am willing to follow the trial's rules on birth control and pregnancy testing.I have had radiation therapy for my head or neck cancer.I am currently on medication for hepatitis B.I am currently receiving treatment that boosts my immune system.
Research Study Groups:
This trial has the following groups:- Group 1: Neoadjuvant and Adjuvant
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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