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Chemotherapy

NIS793 for Pancreatic Cancer

Phase 2
Waitlist Available
Research Sponsored by Kimberly Perez, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization (or registration) to the earlier of progression or death due to any cause. participants alive without disease progression are censored at date of last disease evaluation up to 5 years.
Awards & highlights

Study Summary

This trial is being done to see if adding NIS793 to the standard chemotherapy treatment FOLFIRINOX is safe and improves treatment of pancreatic cancer.

Eligible Conditions
  • Borderline Resectable Pancreatic Cancer
  • Pancreatic Cancer
  • Pancreatic Adenocarcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization (or registration) to the earlier of progression or death due to any cause. participants alive without disease progression are censored at date of last disease evaluation up to 5 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization (or registration) to the earlier of progression or death due to any cause. participants alive without disease progression are censored at date of last disease evaluation up to 5 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Major pathological response rate (MPR)
Secondary outcome measures
Therapeutic procedure
Median Overall Survival (OS)
Median Progression-free survival (PFS)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: mFOLFIRINOX + NIS793Experimental Treatment8 Interventions
Participants will be randomly assigned to receive: FOLFIRINOX + NIS793 on day 1 of each 14 day cycle up to 8 cycles/16 weeks Cycles 9+: 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
Group II: mFOLFIRINOXActive Control7 Interventions
Participants will be randomly assigned to receive: FOLFIRINOX on day 1 of each 14 day cycle up to 8 cycles/16 weeks Cycles 9+: 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mFOLFIRINOX
2013
Completed Phase 2
~40
5-Fluorouracil (5-FU)
2003
Completed Phase 3
~5560
Oxaliplatin
2011
Completed Phase 4
~2560
Irinotecan
2017
Completed Phase 4
~2680
Leucovorin
2005
Completed Phase 4
~5730
NIS793
2017
Completed Phase 1
~120
Chemoradiation
2006
Completed Phase 3
~990
Surgery
2000
Completed Phase 3
~2550

Find a Location

Who is running the clinical trial?

Kimberly Perez, MDLead Sponsor
1 Previous Clinical Trials
52 Total Patients Enrolled
NovartisIndustry Sponsor
1,610 Previous Clinical Trials
2,719,262 Total Patients Enrolled
Kimberly PerezLead Sponsor
1 Previous Clinical Trials
52 Total Patients Enrolled

Media Library

FOLFIRINOX (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05546411 — Phase 2
Pancreatic Cancer Research Study Groups: mFOLFIRINOX + NIS793, mFOLFIRINOX
Pancreatic Cancer Clinical Trial 2023: FOLFIRINOX Highlights & Side Effects. Trial Name: NCT05546411 — Phase 2
FOLFIRINOX (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05546411 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the short- and long-term risks associated with taking NIS793?

"NIS793 received a score of 2 for safety. This is due to NIS793 being in Phase 2 clinical trials, where there is some evidence supporting safety but not yet efficacy."

Answered by AI

Is there currently room for new participants in this trial?

"As of now, this clinical trial is not recruiting patients. The most recent update on the status of recruitment was on September 16th, 2022. Although this specific study has completed its participant quota, there are 1,400 other trials with open enrolment at the moment."

Answered by AI

Who else is applying?

What site did they apply to?
Brigham and Women's Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
A Trial of NIS793 With FOLFIRINOX in Pancreatic Cancer
Kimberly Perez, MD 2023. "A Trial of NIS793 With FOLFIRINOX in Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05546411.
~4 spots leftby Apr 2025
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