A Trial of NIS793 With FOLFIRINOX in Pancreatic Cancer

Status Terminated

Clinical Trial Summary

This study is being done to evaluate the safety and efficacy of adding NIS793 to standard of care FOLFIRINOX treatment for pancreatic cancer. The names of the study interventions involved in this study are: - NIS793 - FOLFIRINOX (Folinic acid/Leucovorin, 5-Fluorouracil, Irinotecan, and Oxaliplatin) Other interventions may include: - Chemoradiation Therapy - Surgery

Clinical Trial Description

This is a randomized phase 2 study evaluating the efficacy of NIS793, a TGF-beta inhibitor, when added to a standard chemotherapy program of modified FOLFIRINOX for people with previously-untreated, resectable or borderline resectable pancreatic adenocarcinoma. The U.S. Food and Drug Administration (FDA) has not approved NIS793 as a treatment for any disease. NIS793 works by blocking a molecule called TGF-beta. TGFbeta has been shown to promote the growth of pancreatic cancer and this study is examining if the addition of a TGF-beta blocking drug will allow the chemotherapy to work better against the cancer. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants will be randomized into two groups of: - Arm A will receive standard chemotherapy, mFOLFIRINOX, in combination with NIS793. - Arm B will receive standard chemotherapy, mFOLFIRINOX. Based on study team determination, some participants may be offered chemoradiation following completion of chemotherapy and/or surgery following either completion of chemotherapy or chemoradiation. Study treatment is expected to last up to 16 weeks unless disease symptom worsens . It is expected that about 45 people will take part in this research study. ;

Study Design

Related Conditions & MeSH terms

Adenocarcinoma
Borderline Resectable Pancreatic Adenocarcinoma
Pancreatic Adenocarcinoma
Pancreatic Cancer
Pancreatic Neoplasms
Resectable Pancreatic Cancer

Clinical Trial Details

NCT number	NCT05546411
Study type	Interventional
Source	Dana-Farber Cancer Institute
Contact
Status	Terminated
Phase	Phase 2
Start date	January 6, 2023
Completion date	October 13, 2023

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