Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

daNIS-1 : 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)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Pancreas<br/>CancersCancer LocationPancreas
Cancers

Systemic therapy | Stomach and upper gastrointestinal tractPancreas

Trial Overview Read MoreRead more

This phase II trial is trying to understand how safe and effective a targeted therapy drug (NIS793) is with and without another targeted therapy drug (spartalizumab) in combination with chemotherapy (gemcitabine/nab-paclitaxel), compared with chemotherapy alone in people with untreated metastatic pancreatic ductal cancer.
 

This trial is treating patients with metastatic pancreatic ductal adenocarcinoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific 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)

Commercial Sponsor

Novartis Pharmaceuticals

Summary

This is a randomised, open label trial with a safety run-in, two experimental arms, and one active comparator arm. The safety run-in involes a combination of NIS793 + spartalizumab + gemcitabine + nab-paclitaxel. Participants in Experimental Arm 1 will receive a combination of NIS793 + spartalizumab + gemcitabine + nab-paclitaxel. Participants in Experimental Arm 2 will receive a combination of NIS793 + gemcitabine + nab-paclitaxel. Participants in the Active Comparator arm will receive gemcitabine + nab-paclitaxel.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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