New combo therapy shows promise for Tough-to-Treat head and neck cancer

NCT ID NCT05523323

Completed Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tested whether adding lenvatinib to pembrolizumab (Keytruda) helps people with recurrent or metastatic head and neck squamous cell carcinoma that has a specific marker (PD-L1). The study enrolled 112 participants and compared the combination against pembrolizumab alone. Researchers measured tumor shrinkage, progression-free survival, and overall survival.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: pembrolizumab (Keytruda) and lenvatinib (Lenvima)
What this could lead to: If successful, this combination could offer a new first-line treatment option for people with recurrent or metastatic head and neck cancer, potentially improving response rates and survival.
What could go wrong: This is a completed Phase 3 trial, but results are not yet published. Adding lenvatinib may increase side effects without clear benefit over pembrolizumab alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HEAD AND NECK SQUAMOUS CELL CARCINOMA

Contacts and locations

Locations

Anhui Cancer Hospital-Radiology Department ( Site 3333)

Hefei, Anhui, 230031, China
Beijing Cancer Hospital ( Site 3314)

Beining, Beijing Municipality, 100036, China
Beijing Tongren Hospital affiliated to Capital Medical University ( Site 3343)

Beijing, Beijing Municipality, 100730, China
Changzhou Tumor Hospital - Changzhou Fourth People's Hospital ( Site 3339)

Changzhou, Jiangsu, 213000, China
Chongqing Cancer Hospital ( Site 3327)

Chongqing, Chongqing Municipality, 400030, China
Fudan University Shanghai Cancer Center ( Site 3324)

Shanghai, Shanghai Municipality, 200032, China
Fujian Provincial Cancer Hospital ( Site 3326)

Fuzhou, Fujian, 350014, China
Guangxi Medical University Affiliated Tumor Hospital ( Site 3322)

Nanning, Guangxi, 530000, China
Guizhou Cancer Hospital ( Site 3330)

Guiyang, Guizhou, 550003, China
Henan Cancer Hospital ( Site 3309)

Zhengzhou, Henan, 450008, China
Hunan Cancer Hospital ( Site 3311)

Changsha, Hunan, 410000, China
Hunan Cancer Hospital ( Site 3334)

Changsha, Hunan, 410013, China
Jiangxi Cancer Hospital ( Site 3313)

Nanchang, Jiangxi, 330029, China
Jilin Cancer Hospital ( Site 3310)

Changchun, Jilin, 130000, China
Peking Union Medical College Hospital ( Site 3304)

Bejiing, Beijing Municipality, 100032, China
Shanghai 9th People hospital ( Site 3332)

Shanghai, Shanghai Municipality, 200011, China
Shanghai East Hospital ( Site 3300)

Shanghai, Shanghai Municipality, 200120, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 3336)

Guangzhou, Guangdong, 510000, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 3338)

Guangzhou, Guangdong, 510000, China
The First Affiliated Hospital of Xi an Jiaotong University ( Site 3328)

Xi'an, Shaanxi, 710000, China
The First Affiliated Hospital, Sun Yat-sen University ( Site 3344)

Guangzhou, Guangdong, 510080, China
The Third Affiliated Hospital of Harbin Medical University ( Site 3302)

Harbin, Heilongjiang, 150081, China
Tianjin Medical University Cancer Hospital ( Site 3312)

Tianjin, Tianjin Municipality, 300060, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 3316)

Wuhan, Hubei, 430030, China
West China Hospital of Sichuan University ( Site 3308)

Chengdu, Sichuan, 610047, China
Wuhan Union hospital Cancer Center ( Site 3307)

Wuhan, Hubei, 430000, China
Xiangya Hospital of Central South University ( Site 3305)

Changsha, Hunan, 410008, China
Zhejiang Cancer Hospital ( Site 3303)

Hangzhou, Zhejiang, 310022, China

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