NIS793 in combination with gemcitabine and nab-paclitaxel for mPDAC

• Research type

  Research Study

• Full title

  A randomized, double-blind, phase III study comparing NIS793 in combination with gemcitabine and nab-paclitaxel versus placebo combined with gemcitabine and nab-paclitaxel for first line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC)

• IRAS ID

  303399

• Contact name

  Mark Middleton

• Contact email

  mark.middleton@oncology.ox.ac.uk

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2021-000591-10

• Duration of Study in the UK

  4 years, 2 months, 20 days

• Research summary

  A study to evaluate the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo in first line who have metastatic pancreatic ductal adenocarcinoma.

  The study will have two parts:
  Part 1 - The Safety run-in part which is an open labelled combination of NIS793 with standard of care therapy (gemcitabine/nab-paclitaxel) this is to assess the recommended phase 3 dose of NIS793

  Part 2 - The Randomised Part. Patients will be randomized to one of two treatments arms:
  Arm A - NIS793 + gemcitabine + nab-paclitaxel
  Arm B - Placebo + gemcitabine + nab-paclitaxel
  About 480 participants will take part in the Randomized part of the study and approximately 10 patients in the Safety run-in phase of the study.

  Each 28 day period is known as a 'cycle.
  NIS793 gemcitabine and nab- paclitaxel are administered via intravenous infusions

  NIS793 will be administered at day 1 and day 15. Gemcitabine and nab-paclitaxel will be adminstered at days 1, 8 and 15 of each cycle.

  Participants will visit the hospital for a screening visit(s), and then three times a month.

  Participants will be in the study as long as they are benefitting from the study treatment.

  Taking part in this study may not benefit participants directly. A participant will be treated with gemcitabine and nab-paclitaxel as a minimum as this is standard treatment patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).Whether adding NIS793 with the addition of gemcitabine and nab-paclitaxel could be beneficial is being explored as part of this study.

  The study is organised and funded by Novartis Pharmacy AG and run by medical staff in hospitals

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  22/NW/0250

• Date of REC Opinion

  4 Nov 2021

• REC opinion

  Further Information Favourable Opinion