Clinical trial NCT05546411
Conditions: Pancreatic Cancer Resectable Pancreatic Cancer Borderline Resectable Pancreatic Adenocarcinoma Pancreatic Adenocarcinoma
Keywords: Pancreatic Cancer Resectable Pancreatic Cancer Borderline Resectable Pancreatic Adenocarcinoma Pancreatic Adenocarcinoma
Sponsor: Kimberly Perez, MD
Start date: 2023-01-06; Completion date: 2023-10-13
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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

Detailed description:
This is a randomized phase 2 study evaluating the efficacy of NIS793, a TGF-beta inhibitor, when added to a standard chemotherapy program of modified FOLFIRINOX for people with previously-untreated, resectable or borderline resectable pancreatic adenocarcinoma.

The U.S. Food and Drug Administration (FDA) has not approved NIS793 as a treatment for any disease. NIS793 works by blocking a molecule called TGF-beta. TGFbeta has been shown to promote the growth of pancreatic cancer and this study is examining if the addition of a TGF-beta blocking drug will allow the chemotherapy to work better against the cancer.

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

Participants will be randomized into two groups of:

* Arm A will receive standard chemotherapy, mFOLFIRINOX, in combination with NIS793.
* Arm B will receive standard chemotherapy, mFOLFIRINOX.

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.

Study treatment is expected to last up to 16 weeks unless disease symptom worsens .

It is expected that about 45 people will take part in this research study.

Arms: arm 1: 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 arm 2: 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
Interventions: intervention 1: mFOLFIRINOX intervention 2: 5-Fluorouracil (5-FU) intervention 3: Oxaliplatin intervention 4: Irinotecan intervention 5: Leucovorin intervention 6: NIS793 intervention 7: Chemoradiation intervention 8: Surgery
Intervention descriptions: intervention 1: Combination of the drugs 5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan, and Leucovorin given by intravenous infusion intervention 2: Part of the FOLFIRINOX drug combination, given by intravenous infusion intervention 3: Part of the FOLFIRINOX drug combination, given by intravenous infusion intervention 4: Part of the FOLFIRINOX drug combination, given by intravenous infusion intervention 5: Part of the FOLFIRINOX drug combination, given by intravenous infusion intervention 6: Given by intravenous infusion intervention 7: Combination of Chemo (Capecitabine) and Radiation Therapy intervention 8: Surgical removal of tumor

Protocol documents:
Prot_SAP_000.pdf: 
[cover page generated for ClinicalTrials.gov only. This page was not part of the IRB approved document  
which follows] 
 
Identifiers: NCT05546411 
Unique Protocol ID: 22-314  
Brief Title: A Trial of NIS793 With FOLFIRINOX in Pancreatic Cancer 
Full Title: A Phase 2 study of neoadjuvant NIS793 in Combination with mFOLFIRINOX in 
resectable and borderline resectable pancreatic adenocarcinoma (PDAC) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date document downloaded from OncPro portal: 4.26.2024  
Document Date: Protocol Version: 03.13.2023 









































































































































































































































ICF_001.pdf: 
[cover page generated for ClinicalTrials.gov only. This page was not part of the IRB approved document  
which follows] 
 
Identifiers: NCT05546411 
Unique Protocol ID: 22-314  
Brief Title: A Trial of NIS793 With FOLFIRINOX in Pancreatic Cancer 
Full Title: A Phase 2 study of neoadjuvant NIS793 in Combination with mFOLFIRINOX in 
resectable and borderline resectable pancreatic adenocarcinoma (PDAC) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date document downloaded from OncPro portal: 4.26.2024  
Document Date: Protocol Version: 05.02.2023