MEDI4736 combination in Pancreatic Ductal Adenocarcinoma (EVEREST)

• Research type

  Research Study

• Full title

  A Phase Ib and II Open-Label, Multi-Center Study of MEDI4736 Evaluated in Different Combinations in Patients with Metastatic Pancreatic Ductal Adenocarcinoma

• IRAS ID

  191416

• Contact name

  Kate Beaujeux

• Contact email

  beaujeuxK@medImmune.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2015-003639-37

• Duration of Study in the UK

  1 years, 11 months, 2 days

• Research summary

  This study is being conducted to look at how safe and effective a new treatment combination (MEDI4736 + AZD5069) is in patients who have pancreatic cancer who tumours have begun to grow again after treatment with chemotherapy. In order to take part in this study, participants must be 18 years old or above. Participants who are eligible for treatment will receive MEDI4736 in combination with AZD5069. MEDI4736 will be given every 4 weeks by intravenous infusion, directly in to a vein over the course of an hour. AZD5069 will be taken as a tablet twice a day. The treatment combination will be given until the patients tumour starts to grow again, an unacceptable toxicity is experienced, the patients withdraws consent to participate or another discontinuation criterion is met. In case of toxicity and at the Investigator’s Discretion, patients may have the option to stop one of the combination treatments and continue treatment with MEDI4736 only or AZD5069 only until the tumour starts to grow again. We will be taking 2 mandatory biopsy samples from the patients once confirmed eligible – Archival sample within last 3 years, if available or a new biopsy sample when the patient enters the study and an additional sample taken 4 weeks after. We also recommend taking an Optional Biopsy sample when tumour has begun to grow again.\n\nParticipants who are eligible for the study will visit the hospital about once a month. During their visit various tests will be conducted; such as blood and urine tests, Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI) scans, electrocardiograms (ECGs) and physical examinations.\n\nApproximately 16 patients will be enrolled in to the study from 6 sites in the UK.

• REC name

  West of Scotland REC 1

• REC reference

  17/WS/0030

• Date of REC Opinion

  13 Mar 2017

• REC opinion

  Further Information Favourable Opinion