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RecruitingLast updated: 15 August 2023

daNIS-1: 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 cancerA 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)

Clinical summary

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.

Conditions

This trial is treating patients with metastatic pancreatic ductal adenocarcinoma.

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Phase

II

Trial Acronym

daNIS-1

More information

Trial Identifiers

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Commercial Sponsor

Novartis Pharmaceuticals

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)

Eligibility

Inclusion

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

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

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