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

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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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