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

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT05435053` - Irreversible Electroporation + Nivolumab for Patients With Metastatic Pancreatic Cancer	Phase 2
Recruiting	`NCT06006390` - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors	Phase 1/Phase 2
Completed	`NCT03109041` - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source	Phase 1
Recruiting	`NCT06065891` - Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer	N/A
Recruiting	`NCT06010862` - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors	Phase 1
Recruiting	`NCT05048524` - Peri-operative SLOG for Localized Pancreatic Cancer	Phase 2
Suspended	`NCT05124743` - HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors
Recruiting	`NCT05351983` - Patient-derived Organoids Drug Screen in Pancreatic Cancer	N/A
Recruiting	`NCT05679674` - Stereotactic Body Radiation and Tumor Treating Fields for Locally Advanced Pancreas Cancer	N/A
Recruiting	`NCT05501379` - Comparison of the Physical Activity in Cancer Patients Assessed by Questionnaire and Motion Tracker
Recruiting	`NCT04851106` - Evaluation of Endoscopic Ultrasound Shear Wave Elastography (EUS-SWE) for the Diagnosis of Pancreatic Adenocarcinoma.
Enrolling by invitation	`NCT04466189` - Prospective Cohort Study of Pancreatic Cancer Patients Treated With Proton Beam Therapy
Terminated	`NCT01313416` - Gemcitabine and CT-011 for Resected Pancreatic Cancer	Phase 2
Recruiting	`NCT01411072` - Biomarker Directed Adjuvant Chemotherapy for Resected Pancreas Cancer	N/A
Active, not recruiting	`NCT01448668` - Iscador Qu as Supportive Treatment in Pancreatic Cancer (Union for International Cancer Control, UICC Stages II-IV)	N/A
Completed	`NCT01155882` - Registry Study - Whipple at the Splenic Artery
Recruiting	`NCT04970056` - Pancreatic Cancer Early Detection Consortium
Recruiting	`NCT04140526` - Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC	Phase 1/Phase 2
Withdrawn	`NCT03682744` - CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC)	Phase 1
Recruiting	`NCT06036563` - Prospective Screening and Differentiating Common Cancers Using Peripheral Blood Cell-Free DNA Sequencing