FOLFIRINOX + NIS793 in Pancreatic Cancer

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.

Conditions

• Pancreas Cancer
• Metastatic Pancreatic Cancer
• Metastatic Pancreatic Adenocarcinoma

Interventions

DRUG

FOLFIRINOX

Combination of the drugs 5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan, and Leucovorin given by intravenous infusion

DRUG

Oxaliplatin

Part of the FOLFIRINOX drug combination, given by intravenous infusion

DRUG

Leucovorin

Part of the FOLFIRINOX drug combination, given by intravenous infusion

DRUG

Irinotecan

Part of the FOLFIRINOX drug combination, given by intravenous infusion

DRUG

5-Fluorouracil (5-FU)

Part of the FOLFIRINOX drug combination, given by intravenous infusion

DRUG

NIS793

Given by intravenous infusion

RADIATION

Chemoradiation

Combination of Chemo (Capecitabine) and Radiation Therapy

DRUG

Capecitabine

Taken Orally as part of Chemoradiation

RADIATION

Radiation Therapy

Radiation Therapy as part of Chemoradiation

PROCEDURE

Surgery

Surgical removal of tumor

Sponsors & Collaborators

• Novartis

  collaborator INDUSTRY

• Colin D. Weekes, M.D., PhD

  lead OTHER

Principal Investigators

• Colin D Weekes, MD, PHD · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-08-09

Primary Completion

2023-07-10

Completion

2023-07-10

FDA Drug

Yes

Countries

• United States

Study Locations