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Be Part of Research - Trial Details - Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014)
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Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014)

Not Recruiting

Open to: ALL

Age: 18.0 - N/A

Cambridge Nottingham London London London Manchester Edinburgh Sutton Dundee

Medical Conditions

Carcinoma
Esophageal Squamous Cell Carcinoma
Esophageal Neoplasms

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.


The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma.

The primary hypotheses are that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

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:

Jul 2021 Jan 2027

INTERVENTIONAL

Intervention Type : BIOLOGICAL
Intervention Description : 400 mg once every 6-week-cycle, via IV infusion.

Intervention Arm Group : Part 1: Pembrolizumab + Lenvatinib + Chemotherapy;Part 2: Pembrolizumab + Chemotherapy;Part 2: Pembrolizumab + Lenvatinib + Chemotherapy;

Intervention Type : DRUG
Intervention Description : 8 mg QD (induction) or 20 mg QD (consolidation) via oral capsule.

Intervention Arm Group : Part 1: Pembrolizumab + Lenvatinib + Chemotherapy;Part 2: Pembrolizumab + Lenvatinib + Chemotherapy;

Intervention Type : DRUG
Intervention Description : 80 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy or 75 mg/m\^2 Q3W via infusion, as part of investigator's choice TP chemotherapy.

Intervention Arm Group : Part 1: Pembrolizumab + Lenvatinib + Chemotherapy;Part 2: Pembrolizumab + Lenvatinib + Chemotherapy;

Intervention Type : DRUG
Intervention Description : 4000 mg/m\^2 Q3W via IV infusion, as part of investigator's choice FP chemotherapy or 400 mg/m\^2 Q2W via bolus IV infusion followed by 2400 mg/m\^2 Q2W via continuous IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy.

Intervention Arm Group : Part 1: Pembrolizumab + Lenvatinib + Chemotherapy;Part 2: Pembrolizumab + Chemotherapy;Part 2: Pembrolizumab + Lenvatinib + Chemotherapy;

Intervention Type : DRUG
Intervention Description : 85 mg/m\^2 Q2W via IV infusion, as part of investigator's choice mFOLFOX6 chemotherapy.

Intervention Arm Group : Part 2: Pembrolizumab + Chemotherapy;Part 2: Pembrolizumab + Lenvatinib + Chemotherapy;

Intervention Type : DRUG
Intervention Description : 400 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.

Intervention Arm Group : Part 2: Pembrolizumab + Chemotherapy;Part 2: Pembrolizumab + Lenvatinib + Chemotherapy;

Intervention Type : DRUG
Intervention Description : 200 mg/m\^2 Q2W as part of investigator's choice mFOLFOX6 chemotherapy.

Intervention Arm Group : Part 2: Pembrolizumab + Chemotherapy;Part 2: Pembrolizumab + Lenvatinib + Chemotherapy;

Intervention Type : DRUG
Intervention Description : 175 mg/m\^2 Q3W via IV infusion, as part of investigator's choice TP chemotherapy.

Intervention Arm Group : Part 1: Pembrolizumab + Lenvatinib + Chemotherapy;Part 2: Pembrolizumab + Chemotherapy;Part 2: Pembrolizumab + Lenvatinib + Chemotherapy;



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.

  • Cambridge University Hospitals NHSFT ( Site 1908)
    Cambridge
    Cambridgeshire
    CB2 2QQ
  • Nottingham University Hospital NHS Trust ( Site 1910)
    Nottingham
    England
    NG5 1PF
  • St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1915)
    London
    London, City Of
    EC1A 7BE
  • University College London Hospitals NHS Foundation Trust ( Site 1901)
    London
    London, City Of
    NW1 2BU
  • Royal Marsden NHS Foundation Trust ( Site 1905)
    London
    London, City Of
    SW3 6JJ
  • The Christie NHS Foundation Trust ( Site 1909)
    Manchester
    M20 4BX
  • Western General Hospital ( Site 1912)
    Edinburgh
    Midlothian
    EH4 2XU
  • Royal Marsden NHS Trust. ( Site 1906)
    Sutton
    London, City Of
    SM2 5PT
  • Ninewells Hospital and Medical School ( Site 1907)
    Dundee
    Dundee City
    DD2 1SG


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: NCT04949256
Last updated 05 March 2025

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