Study of NIS793 and Other Novel Investigational Combinations With SOC Anti-cancer Therapy for the 2L Treatment of mCRC
Reason given: The study was terminated early due to the halt of NIS793 treatment and urgent safety measures issued in July and August 2023, respectively, as continued evaluation of Standard of Care alone will not support the trial's purpose.
Key facts
- Where
- Berlin, Bochum, Dresden, Essen, Frankfurt am Main, Hamburg, and Ulm, GermanySee the 7 sites
- Phase
- Phase 2
Where in Germany
- BerlinBerlin, GermanyNo longer taking part
- BochumBochum, GermanyNo longer taking part
- DresdenDresden, GermanyNo longer taking part
- EssenEssen, GermanyNo longer taking part
- Frankfurt am MainFrankfurt am Main, GermanyNo longer taking part
- HamburgHamburg, GermanyNo longer taking part
- UlmUlm, GermanyNo longer taking part
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT04952753
- Record updated
- 26 March 2025
- Original description
The purpose of this study is to evaluate the preliminary efficacy and safety of NIS793 and other novel investigational combinations with standard of care (SOC) anti-cancer therapy vs SOC anti-cancer therapy for the second line treatment of mCRC.Read full original descriptionShow less
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)
The purpose of this study is to evaluate the preliminary efficacy and safety of NIS793 and other novel investigational combinations with standard of care (SOC) anti-cancer therapy vs SOC anti-cancer therapy for the second line treatment of mCRC.
This study aims to explore whether different mechanisms of action may reverse resistance and improve responsiveness to the currently considered SOC anti-cancer therapy in the second line metastatic colorectal cancer (mCRC) setting.
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; 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; 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; Microsatellite instability-high (MSI-H)/mismatch repair-deficient (dMMR) and/or BRAFV600 mutation positive colorectal cancer; 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; 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); 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.