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A Trial of NIS793 With FOLFIRINOX in Pancreatic Cancer

NCT05546411 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-12-17

Study results available
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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

Conditions

  • Pancreatic Cancer
  • Resectable Pancreatic Cancer
  • Borderline Resectable Pancreatic Adenocarcinoma
  • Pancreatic Adenocarcinoma

Interventions

DRUG

mFOLFIRINOX

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

DRUG

5-Fluorouracil (5-FU)

Part of the FOLFIRINOX drug combination, given by intravenous infusion

DRUG

Oxaliplatin

Part of the FOLFIRINOX drug combination, given by intravenous infusion

DRUG

Irinotecan

Part of the FOLFIRINOX drug combination, given by intravenous infusion

DRUG

Leucovorin

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

PROCEDURE

Surgery

Surgical removal of tumor

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Kimberly Perez, MD

    lead OTHER

Principal Investigators

  • Kimberly Perez, MD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-06
Primary Completion
2023-08-16
Completion
2023-10-13
FDA Drug
Yes

Countries

  • United States

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 NCT05546411 on ClinicalTrials.gov