Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Study Location:

Find another location


Questions to ask
Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975)
Back

Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975)

Not Recruiting

Open to: ALL

Age: 18.0 - N/A

Aberdeen Cambridge London London London Nottingham Sutton London Manchester Northwood

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 treatment with definitive chemoradiotherapy (dCRT) + pembrolizumab (MK-3475) compared to treatment with dCRT + placebo with respect to Event-free Survival (EFS) and Overall Survival (OS) in:

* participants whose tumors express Programmed Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10 * participants whose tumors express PD-L1 CPS ≥1 * all participants

The primary study hypotheses are that dCRT+ pembrolizumab is better than dCRT + placebo with respect to:

* EFS in participants whose tumors express PD-L1 CPS ≥10 * EFS in participants whose tumors express PD-L1 CPS ≥1 * EFS in all participants * OS in participants whose tumors express PD-L1 CPS ≥10 * OS in participants whose tumors express PD-L1 CPS ≥1 * OS in all participants

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:

Feb 2020 Feb 2027

Publications

"Shah MA, Bennouna J, Doi T, Shen L, Kato K, Adenis A, Mamon HJ, Moehler M, Fu X, Cho BC, Bordia S, Bhagia P, Shih CS, Desai A, Enzinger P. KEYNOTE-975 study design: a Phase III study of definitive chemoradiotherapy plus pembrolizumab in patients with esophageal carcinoma. Future Oncol. 2021 Apr;17(10):1143-1153. doi: 10.2217/fon-2020-0969. Epub 2021 Feb 3."; "33533655"

INTERVENTIONAL

Intervention Type : BIOLOGICAL
Intervention Description : IV infusion

Intervention Arm Group : Pembrolizumab+FP or FOLFOX Therapy+Radiotherapy;

Intervention Type : DRUG
Intervention Description : IV infusion

Intervention Arm Group : Placebo+FP or FOLFOX Therapy+Radiotherapy;

Intervention Type : DRUG
Intervention Description : IV infusion

Intervention Arm Group : Pembrolizumab+FP or FOLFOX Therapy+Radiotherapy;Placebo+FP or FOLFOX Therapy+Radiotherapy;

Intervention Type : DRUG
Intervention Description : IV infusion

Intervention Arm Group : Pembrolizumab+FP or FOLFOX Therapy+Radiotherapy;Placebo+FP or FOLFOX Therapy+Radiotherapy;

Intervention Type : RADIATION
Intervention Description : external radiation

Intervention Arm Group : Pembrolizumab+FP or FOLFOX Therapy+Radiotherapy;Placebo+FP or FOLFOX Therapy+Radiotherapy;

Intervention Type : DRUG
Intervention Description : IV infusion

Intervention Arm Group : Pembrolizumab+FP or FOLFOX Therapy+Radiotherapy;Placebo+FP or FOLFOX Therapy+Radiotherapy;

Intervention Type : DRUG
Intervention Description : IV infusion

Intervention Arm Group : Pembrolizumab+FP or FOLFOX Therapy+Radiotherapy;Placebo+FP or FOLFOX Therapy+Radiotherapy;

Intervention Type : DRUG
Intervention Description : IV infusion

Intervention Arm Group : Pembrolizumab+FP or FOLFOX Therapy+Radiotherapy;Placebo+FP or FOLFOX Therapy+Radiotherapy;



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 0474)
    Aberdeen
    Aberdeen City
    AB25 2ZN
  • Cambridge University Hospitals NHS Trust ( Site 0477)
    Cambridge
    Cambridgeshire
    CB2 0QQ
  • Royal Free Hospital ( Site 0702)
    London
    England
    NW32QG
  • ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 0283)
    London
    London, City Of
    SW3 6JJ
  • Hammersmith Hospital-Medical Oncology ( Site 0471)
    London
    London, City Of
    W12 OHS
  • Nottingham University Hospitals NHS Trust ( Site 0476)
    Nottingham
    Nottinghamshire
    NG5 1PB
  • Royal Marsden Hospital (Sutton) ( Site 0281)
    Sutton
    Surrey
    SM2 5PT
  • University College Hospital NHS Foundation Trust ( Site 0701)
    London
    Worcestershire
    NW1 2PG
  • The Christie NHS Foundation Trust ( Site 0282)
    Manchester
    M20 4BX
  • Mount Vernon Hospital ( Site 0478)
    Northwood
    HA6 2RN


The study is sponsored by Merck Sharp & Dohme LLC



We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?
Read full details for Trial ID: NCT04210115
Last updated 13 November 2024

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

Back to the top