A Trial of NIS793 With FOLFIRINOX in Pancreatic Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Kimberly Perez, MD
Study ID
NCT05546411
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • mFOLFIRINOX — DRUG
    Combination of the drugs 5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan, and Leucovorin given by intravenous infusion
  • 5-Fluorouracil (5-FU) — DRUG
    Part of the FOLFIRINOX drug combination, given by intravenous infusion
  • Oxaliplatin — DRUG
    Part of the FOLFIRINOX drug combination, given by intravenous infusion
  • Irinotecan — DRUG
    Part of the FOLFIRINOX drug combination, given by intravenous infusion
  • Leucovorin — DRUG
    Part of the FOLFIRINOX drug combination, given by intravenous infusion
  • NIS793 — DRUG
    Given by intravenous infusion
  • Chemoradiation — RADIATION
    Combination of Chemo (Capecitabine) and Radiation Therapy
  • Surgery — PROCEDURE
    Surgical removal of tumor

Study Details

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

Key Dates

Start date
Jan 6, 2023
Status verified
Nov 2024
Primary completion
Aug 16, 2023
Completion
Oct 13, 2023

Study Design

Enrollment
8 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: mFOLFIRINOX + NIS793
    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
  • Active Comparator: mFOLFIRINOX
    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

Primary Outcome Measure

Major Pathological Response Rate (MPR) [ Time Frame: Pathology review is done in surgery assessments, once within 14 days prior to the operation. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02215-
Dana-Farber Cancer InstituteBostonMassachusetts02215-

Find similar trials in Boston, MA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Brigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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