FOLFIRINOX + NIS793 in Pancreatic Cancer

Status Recruiting

Clinical Trial Summary

This research is being done to evaluate the safety and effectiveness of the drug NIS793 in combination with the standard of care treatment FOLFIRINOX (consists of the drugs 5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan, and Leucovorin), chemoradiation and surgery for people with metastatic pancreas adenocarcinoma. The drugs involved in this study are: - NIS793 - FOLFIRINOX (consists of the drugs 5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan, and Leucovorin) Other interventions include - chemoradiation - surgery.

Clinical Trial Description

This is a two part Phase 1B study investigating whether NIS793 improves the clinical benefit of FOLFIRINOX treatment for metastatic pancreas adenocarcinoma.The first part is a safety run-in using a dose escalation strategy to determine the recommended phase 2 dose of the drug NIS793. In the second part participants will be a randomized assigned to receive either FOLFIRINOX plus NIS793 or FOLFIRINOX alone. NIS793 binds to the protein that can be found on tumor cells, called TGFβ, thereby preventing its role in cancer metastasis (spreading). FOLFIRINOX is a combination of 4 chemotherapy drugs that may help shrink tumors. The U.S. Food and Drug Administration (FDA) has not approved NIS793 as a treatment for any disease. The FDA has approved FOLFIRINOX as a treatment option for metastatic pancreas adenocarcinoma The FDA has not approved the combination of NIS793 and FOLFIRINOX as a treatment for any disease. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. It is expected that about 50 people will take part in this research study. Novartis, a pharmaceutical company, is supporting this research study by providing funding for the study, including the study drug. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05417386
Study type	Interventional
Source	Massachusetts General Hospital
Contact	Colin D Weekes, MD, PhD
Phone	617-724-8700
Email	cdweekes@mgh.harvard.edu
Status	Recruiting
Phase	Phase 1
Start date	August 9, 2022
Completion date	May 1, 2025

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