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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
Study Summary
This trial tests if a combination of drugs before & after surgery and radiation can help control a type of head & neck cancer.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
2020
Completed Phase 2
~350
Atezolizumab
2017
Completed Phase 3
~5860
Standard of Care
2017
Completed Phase 4
~4420
Questionnaires
2013
Completed Phase 2
~3330
Cisplatin
2013
Completed Phase 3
~1940
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,447 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,114 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How reliable is Neoadjuvant and Adjuvant treatment for patient safety?
"Neoadjuvant and Adjuvant therapies have undergone sufficient safety testing to warrant a score of 2. While there is clinical data supporting their security, no equivalent efficacy studies exist at this time."
Answered by AI
Is enrollment for this research project still available?
"The records available on clinicaltrials.gov suggest that this particular medical trial is presently not accepting participants, as the last edit to it was done on December 27th 2022. However, 2600 other research projects are currently open for enrolment."
Answered by AI
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