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Be Part of Research - Trial Details - Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009)
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Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009)

Not Recruiting

Open to: ALL

Age: 18.0 - N/A

Aberdeen Cottingham Glasgow London Southampton London London Taunton Sutton Manchester

Medical Conditions

Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Researchers are looking for new ways to treat people with head and neck cancer whose cancer has come back after treatment (recurrent) or whose cancer has spread to other parts of the body (metastatic). Some people with recurrent or metastatic head and neck cancer are treated with chemotherapy and immunotherapy, but the cancer gets worse.

The goal of this study is to learn if more people who receive lenvatinib and pembrolizumab have a better overall survival rate than people who receive standard chemotherapy treatment.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Aug 2020 May 2024

Publications

"Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10."; "33300372"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : 20 mg once daily, taken as oral capsules

Intervention Arm Group : Lenvatinib + Pembrolizumab;

Intervention Type : BIOLOGICAL
Intervention Description : 200 mg 30-minute IV infusion on day 1 of each 21-day cycle

Intervention Arm Group : Lenvatinib + Pembrolizumab;

Intervention Type : DRUG
Intervention Description : 75 mg/m\^2 administered as an IV infusion on day 1 of each 21-day cycle

Intervention Arm Group : SOC Chemotherapy;

Intervention Type : DRUG
Intervention Description : 1250 mg/m\^2 twice daily on days 1-14 of each 21-day cycle, taken as oral tablets

Intervention Arm Group : SOC Chemotherapy;

Intervention Type : DRUG
Intervention Description : 80 mg/m\^2 administered as an IV infusion on days 1, 8, and 15 of each 21-day cycle

Intervention Arm Group : SOC Chemotherapy;

Intervention Type : DRUG
Intervention Description : 400 mg/m\^2 loading dose, followed by 250 mg/m\^2 administered as an IV infusion on days 1, 8, and 15 of each 21-day cycle

Intervention Arm Group : SOC Chemotherapy;

Intervention Type : DRUG
Intervention Description : 24 mg once daily, taken as oral capsules

Intervention Arm Group : Lenvatinib Monotherapy;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Aberdeen Royal Infirmary ( Site 0911)
    Aberdeen
    Aberdeen City
    AB25 2ZN
  • Castle Hill Hospital ( Site 0910)
    Cottingham
    East Riding Of Yorkshire
    HU16 5JQ
  • The Beatson West of Scotland Cancer Centre ( Site 0909)
    Glasgow
    Glasgow City
    G12 0YN
  • Guy s and St Thomas Hospital NHS Foundation Trust ( Site 0903)
    London
    Great Britain
    SE1 9RT
  • University Hospital Southampton NHS Foundation Trust ( Site 0905)
    Southampton
    Hampshire
    SO16 6YD
  • Royal Marsden Hospital ( Site 0902)
    London
    London, City Of
    SW3 6JJ
  • Charing Cross Hospital ( Site 0908)
    London
    London, City Of
    W6 8RF
  • Musgrove Park Hospital ( Site 0904)
    Taunton
    Somerset
    TA1 5DA
  • Royal Marsden Hospital. ( Site 0901)
    Sutton
    Surrey
    SM2 5PT
  • The Christie NHS Foundation Trust ( Site 0907)
    Manchester
    m20 4bx


The study is sponsored by Merck Sharp & Dohme LLC and is in collaboration with Eisai Inc..



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Read full details for Trial ID: NCT04428151
Last updated 21 November 2024

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