FOLFIRINOX + NIS793 in Pancreatic Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Colin D. Weekes, M.D., PhD
Study ID
NCT05417386
Phase
PHASE1
Status
Terminated

Conditions

  • Metastatic Pancreatic Adenocarcinoma
  • Metastatic Pancreatic Cancer
  • Pancreas Cancer

Eligibility Criteria

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

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 9, 2022
Status verified
Nov 2025
Primary completion
Jul 10, 2023
Completion
Jul 10, 2023

Study Design

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

Arms

  • Experimental: Safety Run-In
    Following a 3 + 3 dose escalation design 6-18 participants will receive NIS793 and FOLFIRINOX on day 1 of each 14 day cycle for 3+ cycles until recommended phase 2 dose is determined.
  • Experimental: FOLFIRINOX
    Participants will be randomly assigned to receive: * FOLFIRINOX on day 1 of each 14 day cycle for cycles 1-8 * Cycles 9+: Chemoradiation (CRT) and surgery
  • Experimental: FOLFIRINOX + NIS793
    Participants will be randomly assigned to receive: * FOLFIRINOX FOLFIRINOX + NIS793 on day 1 of each 14 day cycle for cycles 1-8 * Cycles 9+: Chemoradiation (CRT) with NIS793, Surgery, NIS793

Primary Outcome Measure

Safety Run In-Recommended Phase 2 dose (RP2D) [ Time Frame: Up to 2 months after baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital Cancer Center· Boston, MA

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