What side effects are associated with this type of intervention?

Treatments for Head and Neck Squamous Cell Carcinoma (HNSCC), particularly immune checkpoint inhibitors like Tislelizumab, pembrolizumab, and nivolumab, are associated with immune-related adverse events such as skin toxicities (rash, pruritus), gastrointestinal issues (diarrhea, colitis), endocrine disorders (hypothyroidism, adrenal insufficiency), and pneumonitis. Chemotherapy agents like cisplatin and paclitaxel commonly cause nausea, vomiting, neutropenia, and neuropathy. Cetuximab, another targeted therapy, can result in severe skin reactions, hypomagnesemia, and infusion-related reactions.

What prior FDA approvals exist?

Pembrolizumab, an anti-PD-1 monoclonal antibody, has been FDA-approved for the treatment of recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). It has shown efficacy in improving overall survival and progression-free survival in various clinical trials, such as the KEYNOTE-048 study. Another similar drug, nivolumab, also an anti-PD-1 monoclonal antibody, has received FDA approval for HNSCC treatment. These therapies work by targeting the PD-1 pathway, enhancing the immune system's ability to fight cancer cells.

What other types of research exist?

Promising alternatives to Tislelizumab for HNSCC patients include Pembrolizumab and Nivolumab, both of which are anti-PD-1 agents that have demonstrated survival benefits in recurrent/metastatic HNSCC. Additionally, Atezolizumab and Durvalumab, which are anti-PD-L1 agents, have shown similar benefits in early-phase studies. Combination therapies involving these agents with conventional or novel compounds are also being explored to improve outcomes.

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Other

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years and 6 months for reporting.

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 more

Trial 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

Do I qualify?Apply below to find out

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 Head and Neck Squamous Cell Carcinoma (HNSCC) include immune checkpoint inhibitors, such as anti-PD-1 monoclonal antibodies like Tislelizumab, pembrolizumab, and nivolumab. These drugs work by blocking the programmed death-1 (PD-1) receptor on T-cells, preventing cancer cells from evading the immune system. This allows the immune system to recognize and attack the cancer cells more effectively. Additionally, cetuximab, an anti-EGFR monoclonal antibody, targets the epidermal growth factor receptor, inhibiting cancer cell growth and proliferation. These treatments are crucial for HNSCC patients as they offer targeted approaches that can improve survival rates and provide options for those who may not respond to traditional therapies.

Targeted Therapy in Head and Neck Cancer: An Update on Current Clinical Developments in Epidermal Growth Factor Receptor-Targeted Therapy and Immunotherapies.Molecularly targeted therapies in head and neck cancers.Reliability of platelet-derived endothelial cell growth factor as a prognostic factor for oral and oropharyngeal carcinomas.

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor

177 Previous Clinical Trials

28,872 Total Patients Enrolled

Study DirectorStudy DirectorBeiGene

1,228 Previous Clinical Trials

500,884 Total Patients Enrolled

Media Library

Investigational Agent (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05909904 — Phase 2

Head and Neck Squamous Cell Carcinoma Research Study Groups: Tislelizumab + LBL-007, Tislelizumab + BGB-A425 + LBL-007, Tislelizumab + BGB-A425, Tislelizumab

Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: Investigational Agent Highlights & Side Effects. Trial Name: NCT05909904 — Phase 2

Investigational Agent (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05909904 — Phase 2

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