Tislelizumab + Investigational Agents for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+79 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: BeiGene

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests whether tislelizumab, alone or with other new treatments, can help patients with head and neck cancer that has come back or spread. Tislelizumab helps the immune system find and kill cancer cells by blocking a pathway that usually stops this process.

Eligibility Criteria

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.

Inclusion Criteria

My cancer tests positive for PD-L1.

My cancer is in my throat, mouth, or voice box.

Have at least 1 measurable lesion as defined per RECIST v1.1

+5 more

Exclusion 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.

I've had severe allergic reactions to certain medications or serious side effects from immune therapy.

+2 more

Participant Groups

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.

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