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A Phase IIb, Open-label, Randomized Study of Nab-Paclitaxel and Gemcitabine plus/minus VCN-01 in Patients with Metastatic Pancreatic Cancer

Clinical Trial Details

The study will test an investigational product called VCN-01 in patients with metastatic pancreatic cancer. “Investigational” means that VCN-01 has not been approved by the U.S. Food and Drug Administration (FDA) to treat any disease.

VCN-01 will be administered in combination with two standard-of-care chemotherapy drugs called nab-paclitaxel and gemcitabine. The goals of the study are to evaluate the safety and tolerability of VCN-01 and to determine whether co-administration of VCN-01 can improve treatment outcomes in metastatic pancreatic cancer patients treated with nab-paclitaxel and gemcitabine.
   
This clinical study consists of 2 arms. Participants will be randomly assigned to one of the following arms:

  • Arm 1: Receives Nab-paclitaxel and gemcitabine as standard of care. Patients in this arm will not receive VCN-01.
  • Arm 2: A maximum of two doses of VCN-01 administrated in combination with nab-paclitaxel and gemcitabine standard of care.   

Total participation will last for approximately for 2 years. 

Key Eligibility: 

1. Male/female patients aged 18 years or over.
2. Patients with a confirmed diagnosis of metastatic pancreatic adenocarcinoma stage IV who never received previous systemic treatment for their pancreatic cancer.      

Detailed eligibility will be discussed when contacting the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

June Greenberg, RN
(212) 746-2651
jdg2002@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2210025232

ClinicalTrials.gov:

NCT05673811

Sponsor:

P-VCNA-003

Status

Open to Enrollment

Age Group

Adult

Sponsor