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PD-L1 Inhibitor
Combination Therapy for Head and Neck Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by Hoffmann-La Roche
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 from surgery to specified timepoints (1, 2, 3, and 5 years)
Awards & highlights
Study Summary
This trial is for people with HPV-negative, PD-L1-positive head and neck cancer who have not had systemic treatment yet.
Who is the study for?
This trial is for adults with Stage III-IVA squamous cell carcinoma of the head and neck (SCCHN) that's resectable, HPV-negative, and PD-L1-positive. They should not have had previous systemic treatments for SCCHN, must be in good health with proper organ function, no severe infections recently, and cannot be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests combinations of Atezolizumab (an immunotherapy drug), Tiragolumab (another immunotherapy), Carboplatin and Paclitaxel (chemotherapy drugs) on patients who haven't been treated before. It's a randomized trial to see which combination works best at treating this type of cancer.See study design
What are the potential side effects?
Possible side effects include immune-related reactions like inflammation in organs, infusion reactions from the drugs entering the body, blood disorders due to chemotherapy agents affecting bone marrow production, fatigue from treatment burden on the body’s resources, as well as increased risk of infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ randomization to specified timepoints (1, 2, 3, and 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization to specified timepoints (1, 2, 3, and 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathologic Complete Response (pCR), as Determined by Local Pathologic Review
Secondary outcome measures
Duration of Delayed Surgery Due to Treatment-Related Adverse Events
Event-Free Survival (EFS)
Landmark EFS
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Atezo + Tira + CPExperimental Treatment4 Interventions
Participants in the atezolizumab plus tiragolumab plus carboplatin plus paclitaxel arm arm will receive treatment for two cycles (6 weeks) until surgery or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.
Group II: Atezo + TiraActive Control2 Interventions
Participants in the atezolizumab plus tiragolumab arm will receive treatment for two cycles (6 weeks) until surgery or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved
Tiragolumab
Not yet FDA approved
Carboplatin
FDA approved
Paclitaxel
FDA approved
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,964 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,412 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is in the head or neck area and can be surgically removed.I haven't taken any immunosuppressive drugs in the last 2 weeks.My blood and organs are functioning well.My squamous cell carcinoma has spread to distant parts of my body.I am fully active or can carry out light work.I have active tuberculosis.I have or had an autoimmune disease or immune deficiency.I have not had a severe infection in the last 4 weeks.I haven't taken any antibiotics in the last 2 weeks.I do not have serious heart problems like recent heart attacks or unstable heart conditions.I am severely allergic to placlitaxel or platinum-based treatments.I am a candidate for a surgery aimed at completely removing my cancer.I have had lung conditions like pulmonary fibrosis or pneumonitis.I haven't taken any immune-boosting drugs in the last 4 weeks or longer.My throat cancer is not linked to HPV.I haven't had a live vaccine in the last 4 weeks and don't plan to during or within 5 months after the study.I am HIV negative or stable on HIV treatment with good immune function and no detectable virus.My throat cancer is HPV-positive.I have received treatments like immunotherapy, chemotherapy, or radiation for head and neck cancer.My cancer has a PD-L1 score of 1 or higher.I have had a previous transplant of stem cells or an organ.I have been screened for hepatitis B with specific antibody results.I haven't had cancer other than SCCHN in the last 5 years, or if I did, it was very unlikely to spread or be fatal.I don't have any health issues that would make it unsafe for me to take a new drug.I haven't had major surgery in the last 4 weeks and don't expect to need any during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Atezo + Tira + CP
- Group 2: Atezo + Tira
Awards:
This trial has 2 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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 many participants has this research project accommodated thus far?
"Affirmative. The data available on clinicaltrials.gov demonstrates that this research project, initially posted February 28th 2023 is presently recruiting participants. Approximately 180 patients must be recruited from a single medical centre."
Answered by AI
Are there still opportunities for recruitment into this research endeavor?
"Per the information on clinicaltrials.gov, this medical trial is actively recruiting participants. The study was initially published to the website on February 28th 2023 and was last modified on November 4th 2022."
Answered by AI
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