Monday, March 30, 2026
Phase 3 trial tests pembrolizumab with or without lenvatinib for advanced head and neck cancer
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Phase 3 trial tests pembrolizumab with or without lenvatinib for advanced head and neck cancer

Plain Language Summary
What this means for you:
Results from a large head and neck cancer trial are not yet available; more information is needed.

Researchers conducted a Phase 3 clinical trial to test a new combination of drugs for people with advanced head and neck cancer that has returned or spread. The study involved 511 patients whose cancer had a specific marker called PD-L1. They compared the standard immunotherapy drug pembrolizumab to pembrolizumab plus an additional drug called lenvatinib.

The trial measured whether tumors shrank, how long patients lived without their cancer getting worse, and overall survival. However, the detailed results for these main goals have not been released to the public yet. We do not know if the combination worked better or if it caused more side effects.

Because the results are not available, it is impossible to draw any conclusions about the treatment's benefits or risks. The study was funded by the company that makes the drugs. For now, patients should know this research is ongoing, and the standard of care has not changed based on this unreported data.

What this means for you:
Results from a large head and neck cancer trial are not yet available; more information is needed.
Read the Full Clinical Summary →
View Original Abstract ↓
Status: COMPLETED | Phase: PHASE3 Condition(s): Head and Neck Squamous Cell Carcinoma Intervention(s): Lenvatinib (DRUG), Pembrolizumab (BIOLOGICAL), Placebo (DRUG) This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma. Hypotheses include: * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR). * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR. * Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS). Primary Outcome(s): Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR); Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR).; Overall Survival (OS) Enrollment: 511 (ACTUAL) Lead Sponsor: Merck Sharp & Dohme LLC Start: 2020-02-05 | Primary Completion: 2023-05-30 Results posted: 2024-07-16