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Tislelizumab + Investigational Agents for Head and Neck Cancer
Phase 2
Recruiting
Research Sponsored by BeiGene
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 up to approximately 3 years and 6 months
Awards & highlights
Study Summary
This trial tests two drugs to treat head and neck cancer, to see if they are safe and effective.
Who is the study for?
This trial is for adults with head and neck squamous cell carcinoma that hasn't spread too far or been treated systemically in the recurrent/metastatic setting. They must have a certain level of PD-L1 protein expression, at least one tumor measurable by RECIST v1.1 standards, good physical functioning, and proper organ function. Participants can't join if they've had certain other cancers recently, severe lung issues, previous treatments with specific immunotherapies, or serious allergic reactions to similar drugs.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of tislelizumab alone or combined with experimental drugs (BGB-A425 or LBL-007) in treating first-line recurrent or metastatic head and neck cancer. It aims to see how well these combinations work compared to current standard treatments.See study design
What are the potential side effects?
Possible side effects include immune-related conditions affecting lungs like pneumonitis, infusion reactions related to drug administration, fatigue from treatment burden on the body's energy levels, potential blood abnormalities due to bone marrow suppression by chemotherapy agents.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 3 years and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 3 years and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Clinical Benefit Rate (CBR)
Disease Control Rate (DCR)
Duration of Response (DOR)
+4 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Tislelizumab + LBL-007Experimental Treatment2 Interventions
Tislelizumab 200 mg administered once every 3 weeks with LBL-007
Group II: Tislelizumab + BGB-A425 + LBL-007Experimental Treatment3 Interventions
Tislelizumab 200 mg administered once every 3 weeks with BGB-A425 and LBL-007
Group III: Tislelizumab + BGB-A425Experimental Treatment2 Interventions
Tislelizumab 200 mg administered once every 3 weeks with BGB-A425
Group IV: TislelizumabActive Control1 Intervention
Tislelizumab 200 milligrams (mg) administered once every 3 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tislelizumab
2018
Completed Phase 3
~4260
Find a Location
Who is running the clinical trial?
BeiGeneLead Sponsor
175 Previous Clinical Trials
28,665 Total Patients Enrolled
Study DirectorStudy DirectorBeiGene
1,211 Previous Clinical Trials
489,112 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is a recurring or spreading type, originating from the nasopharynx, skin, salivary gland, or is a mucosal melanoma.I have previously been treated with drugs that target the immune system.My cancer tests positive for PD-L1.I've had severe allergic reactions to certain medications or serious side effects from immune therapy.My cancer is in my throat, mouth, or voice box.My recent blood tests show my organs are functioning well.My head or neck cancer cannot be cured with surgery or radiation.I have never had serious lung conditions like interstitial lung disease or uncontrolled pulmonary fibrosis.I haven't had systemic therapy for recurrent/metastatic disease, but may have had it for advanced local disease.I haven't had any cancer other than the one being studied in the last 2 years, except for minor or treated cancers.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Tislelizumab + LBL-007
- Group 2: Tislelizumab + BGB-A425 + LBL-007
- Group 3: Tislelizumab + BGB-A425
- Group 4: Tislelizumab
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.
Is it possible for participants to still join this experiment?
"The trial is still recruiting participants, as evidenced by clinicaltrials.gov's records; it was initially posted on July 21st 2023 and its details were subsequently edited on August 10th 2023."
Answered by AI
What is the scope of this trial's implementation across medical centers?
"Currently, there are 9 sites enrolling for this trial. They can be found in Gold Coast, Greenslopes and Adelaide as well as 6 other cities - individuals should seek out the closest location to reduce travel needs if they decide to participate."
Answered by AI
Has the combination of Tislelizumab and LBL-007 been validated by the US Food & Drug Administration?
"Taking into consideration the data available from a Phase 2 trial, our team at Power assigned Tislelizumab + LBL-007 a safety rating of two; given that there is some evidence to support its safety but none for efficacy."
Answered by AI
How extensive is the patient cohort involved in this medical experiment?
"To participate in this clinical trial, 160 patients must meet the specified eligibility requirements. These enrollees can be recruited from two main medical facilities: Gold Coast Private Hospital and Greenslopes Private Hospital. Both of these locations are located in Australia."
Answered by AI
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