Study of NIS793 and Other Novel Investigational Combinations With SOC Anti-cancer Therapy for the 2L Treatment of mCRC

Phase 2 Terminated 204 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2021-11-15
Primary completion: 2025-01-20
Completion: 2025-01-20

Outcome

Outcome not reported

Stopped: “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.”

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	NISEVOKITUG	Monoclonal antibody	—	Intravenous
Subject	Tislelizumab	Monoclonal antibody	—	Intravenous
Background	Bevacizumab	Monoclonal antibody	—	Intravenous
Background	Irinotecan	Small molecule	—	Intravenous
Background	Leucovorin	Small molecule	—	Intravenous
Background	Levoleucovorin	Unknown	—	Intravenous
Background	Oxaliplatin	Small molecule	—	Intravenous
Background	fluorouracil	Small molecule	—	Intravenous

Study of NIS793 and Other Novel Investigational Combinations With SOC Anti-cancer Therapy for the 2L Treatment of mCRC

Summary

Timeline

Outcome

Drugs

Indications