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

NCT04952753 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2025-03-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

NIS793

Investigational drug NIS793 will be administered intravenously (IV) at the dose and schedule determined in the safety run-in part.

DRUG

Bevacizumab

Bevacizumab will be administered IV

DRUG

Modified FOLFOX6

5-fluorouracil \[continuous infusion\], leucovorin \[administered IV\] (or levoleucovorin \[administered IV\]), and oxaliplatin \[administered IV\]

DRUG

FOLFIRI

5-fluorouracil \[continuous infusion\], leucovorin \[administered IV\] (or levoleucovorin \[administered IV\]), and irinotecan \[administered IV\]

DRUG

Tislelizumab

Investigational drug tislelizumab will be administered intravenously (IV).

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2025-01-20
Completion
2025-01-20
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Hong Kong
  • Israel
  • Italy
  • Japan
  • Singapore
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04952753 on ClinicalTrials.gov