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Be Part of Research - Trial Details - Study of Anti-PD-L1 in Combination With Chemo(Radio)Therapy for Oesophageal Cancer

Study of Anti-PD-L1 in Combination With Chemo(Radio)Therapy for Oesophageal Cancer

Completed

Open to: ALL

Age: 18.0 - N/A

Medical Conditions


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.


This is an open-label, Phase 1/2 study to evaluate the safety of durvalumab (MEDI4736) in combination with oxaliplatin/capecitabine chemotherapy in metastatic/locally advanced oesophageal cancer (OC) and with neoadjuvant chemo(radio)therapy before surgery in operable OC. The immunotherapy will be given for a 4-week period before starting the standard chemo(radio)therapy, continuing durvalumab treatment once the chemotherapy starts. The study will include 2 phases, a safety run-in Phase 1 (Cohorts A1 and A2) and an expansion Phase 2 (Cohorts B, C, C-FLOT, D/D2).

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:

Jun 2016 Jun 2022

Publications

"Bohnsack O, Hoos A, Ludajic K. Adaptation of the immune related response criteria: irRECIST. Ann Oncol. 2014 Sep;25(suppl 4):iv361-iv72 [Abstract 4958]. doi: 10.1093/annonc/mdu342.23."; null

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Anti PD-L1 antibody

Intervention Arm Group : Cohort A1: Metastatic/locally advanced OC, Durva + Chemotherapy (Chemo);Cohort A2: Metastatic/locally advanced OC, Durva, Treme + Chemo;Cohort B: Metastatic/locally advanced OC, Durva, Treme + Chemo;Cohort C-FLOT: Operable OC, Durva + FLOT Chemotherapy;Cohort C: Operable OC; Durva + Chemo;Cohort D/D2: Operable OC, Durva + Neoadjuvant Chemo(radio)therapy;

Intervention Type : DRUG
Intervention Description : Anti CTLA-4 antibody

Intervention Arm Group : Cohort A2: Metastatic/locally advanced OC, Durva, Treme + Chemo;Cohort B: Metastatic/locally advanced OC, Durva, Treme + Chemo;

Intervention Type : DRUG
Intervention Description : IV administered chemotherapy

Intervention Arm Group : Cohort A1: Metastatic/locally advanced OC, Durva + Chemotherapy (Chemo);Cohort A2: Metastatic/locally advanced OC, Durva, Treme + Chemo;Cohort B: Metastatic/locally advanced OC, Durva, Treme + Chemo;Cohort C-FLOT: Operable OC, Durva + FLOT Chemotherapy;Cohort C: Operable OC; Durva + Chemo;

Intervention Type : DRUG
Intervention Description : orally-administered chemotherapy

Intervention Arm Group : Cohort A1: Metastatic/locally advanced OC, Durva + Chemotherapy (Chemo);Cohort A2: Metastatic/locally advanced OC, Durva, Treme + Chemo;Cohort B: Metastatic/locally advanced OC, Durva, Treme + Chemo;Cohort C: Operable OC; Durva + Chemo;

Intervention Type : RADIATION
Intervention Arm Group : Cohort D/D2: Operable OC, Durva + Neoadjuvant Chemo(radio)therapy;

Intervention Type : DRUG
Intervention Description : IV administered chemotherapy

Intervention Arm Group : Cohort D/D2: Operable OC, Durva + Neoadjuvant Chemo(radio)therapy;

Intervention Type : DRUG
Intervention Description : IV administered Chemotherapy

Intervention Arm Group : Cohort D/D2: Operable OC, Durva + Neoadjuvant Chemo(radio)therapy;

Intervention Type : DRUG
Intervention Description : IV administered chemotherapy

Intervention Arm Group : Cohort C-FLOT: Operable OC, Durva + FLOT Chemotherapy;

Intervention Type : DRUG
Intervention Description : chemo-protective agent

Intervention Arm Group : Cohort C-FLOT: Operable OC, Durva + FLOT Chemotherapy;

Intervention Type : DRUG
Intervention Description : IV administered chemotherapy

Intervention Arm Group : Cohort C-FLOT: Operable OC, Durva + FLOT 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.

  • Research Facility
    Dundee
    DD1 9SY
  • Research Facility
    Nottingham
    NG5 1PB
  • Research Facility
    Oxford
    OX3 9DU
  • Research Facility
    Southampton
    SO16 6YD


The study is sponsored by Ludwig Institute for Cancer Research and is in collaboration with AstraZeneca.





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Read full details for Trial ID: NCT02735239
Last updated 12 September 2023

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