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No longer recruiting (closed or complete)Last updated: 3 April 2025

daNIS-3: This trial is assessing different combinations of treatment with standard care for people with metastatic colorectal cancerAn Open-label, Multi-center, ph II Platform Study Evaluating the Efficacy and Safety of NIS793 and Other New Investigational Drug Combinations With SOC Anti-cancer Therapy for the 2L Treatment of Metastatic Colorectal Cancer (mCRC)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Bowel Cancers Lower gastrointestinal tract

Age

People18+

Trial acronym

daNIS-3

Clinical summary

Summary

Eligible patients will be randomised into the control or investigation arm(s) of the study. The control arm will include participants treated with standard of care (SOC) anti-cancer therapy (bevacizumab with mFOLFOX6 or FOLFIRI) for the second line treatment of metastatic colorectal cancer. The choice of the chemotherapy medications (mFOLFOX6 or FOLFIRI) will be determined by the Investigator based on prior exposure to oxaliplatin or irinotecan. Each investigational arm will include a combination of an investigational drug and the SOC anti-cancer therapy.

Conditions

This trial is treating people with metastatic colorectal cancer

Eligibility

Inclusion

  • Participants age 18 or older with histologically or cytologically confirmed (by local laboratory and local clinical guidelines) metastatic colorectal adenocarcinoma that is not amenable to potentially curative surgery in the opinion of the investigator and progressed on or within 6 months after the last dose of one prior line of systemic anti-cancer therapy administered for metastatic disease.
  • Presence of at least one measurable lesion assessed by CT and/or MRI according to RECIST 1.1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
  • Adequate organ function (assessed by central laboratory for eligibility).

Exclusion

  • Previously administered TGF-β targeted therapies or anti-cancer immunotherapy.
  • Microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR) and/or BRAFV600 mutation positive colorectal cancer.
  • Known complete or partial dipyrimidine dehydrogenase (DPD) enzyme deficiency (testing for DPD enzyme deficiency is not mandatory unless required by local regulations and can be conducted at a local laboratory).
  • For participants treated with irinotecan: Known history or clinical evidence of reduced UGT1A1 activity (testing for UGT1A1 status is not mandatory unless required by local regulations and can be conducted at a local laboratory).
  • Participants who have not recovered from a major surgery performed prior to start of study treatment or have had a major surgery within 4 weeks prior to start of study treatment.
  • Impaired cardiac function or clinically significant cardio-vascular disease.
  • Participants with conditions that are considered to have a high risk of clinically significant gastrointestinal tract bleeding or any other condition associated with or history of significant bleeding.
  • Stroke or transient ischemic attack, or other ischemic event, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 3 months before start of study treatment.
  • Pregnant or breast-feeding women.
  • Women of childbearing potential, unless willing to use highly effective contraception methods during treatment and after stopping study treatments as required.

Other inclusion/exclusion criteria may apply

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

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, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Novartis Pharmaceuticals

Scientific Title

An Open-label, Multi-center, ph II Platform Study Evaluating the Efficacy and Safety of NIS793 and Other New Investigational Drug Combinations With SOC Anti-cancer Therapy for the 2L Treatment of Metastatic Colorectal Cancer (mCRC)

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