NIS793 (+/- spartalizumab) with SOC chemotherapy in first-line mPDAC
Research type
Research Study
Full title
A phase II, open label, randomized, parallel arm study of NIS793 (with and without spartalizumab) in combination with SOC chemotherapy gemcitabine/nab-paclitaxel, and gemcitabine/nab-paclitaxel alone in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC)
IRAS ID
285541
Contact name
Mark Middleton
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2020-000349-14
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, 20 days
Research summary
Summary of Research
A study to find out if the drug NIS793 with and without spartalizumab in combination with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone are safe and have beneficial effects in people who have metastatic pancreatic ductal adenocarcinoma.
The study will have two parts.
Part 1 - participants will receive NIS793 with spartalizumab, in combination with gemcitabine and nab-paclitaxel. The purpose of Part 1 is to find out if the study treatment is safe.
Part 2 - participants will have equal chance of being assigned to any of three arms:
Arm 1: NIS793 + spartalizumab + gemcitabine + nab-paclitaxel
Arm 2: NIS793 + gemcitabine + nab-paclitaxel
Arm 3: gemcitabine + nab-paclitaxel
The purpose of Part 2 is to find out if the study treatment is safe and has beneficial effects.About 156 adults with advanced pancreatic cancer will take part.
Each 28 day period is known as a “cycle.”
NIS793 will be administered on Days 1 and 15, spartalizumab on Day 1, and nab-paclitaxel and gemcitabine on Days 1, 8, and 15 of each cycle.
NIS793, spartalizumab, gemcitabine and nab-paclitaxel are administered via intravenous infusion.Participants will visit the hospital for a screening visit(s), and then 3 to 4 times a month.
Participants will be in the study as long as they are benefiting 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 (standard treatment for advanced pancreatic cancer). Whether adding NIS793 with or without spartalizumab in addition to gemcitabine and nab-paclitaxel could be beneficial, is explored as part of this study. Novartis may learn new things that could help treat patients in the future.The study is organised/funded by Novartis Pharma AG and run by medical staff in hospital.
Summary of Results
The English lay summary will be available one year post global LPLV (02-May-2025). It will be available to PIs to share with patients and posted in the public domain on Novartis public website https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.novctrd.com%2F&data=05%7C02%7Capprovals%40hra.nhs.uk%7Cb187e277592b4f143af008ddf77b5d59%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638938831419117897%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=kraLN4IWEEXMJTlSKDWcJSzQOpJ0owAU7%2BTHaKT3LXk%3D&reserved=0“REC name
HSC REC A
REC reference
20/NI/0103
Date of REC Opinion
22 Sep 2020
REC opinion
Further Information Favourable Opinion