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

NCT ID NCT05523323

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

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