NCT03165591

Open Label Immunotherapy Trial of Inoperable Pancreatic Cancer

Open Label Phase II Immunotherapy Trial of Inoperable Pancreatic Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Immunitor LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Pancreatic cancer (PDA) is the most lethal form of cancer, and the fourth-leading cause of cancer-related death in the United States, with a survival rate of less than 7%.There are currently no treatments found to be effective for patients with advanced disease who are ineligible for surgery, a prognosis representing the majority of pancreatic cancer diagnoses. Pancreatic cancer is not amenable to chemotherapy as compared to other cancer types, leaving patients with practically no options except surgery. We have made oral tableted therapeutic vaccine, V3-P, derived from pooled blood of patients with PDA in line with similar highly promising approach we have adopted for patients with hepatocellular carcinoma (HCC) and cholangiocarcinoma (CAA). Patients with PDA will be given one tablet per day of V3-P and followed up to see the outcome.

Detailed description

This study is an open label Phase II study aimed to recruit at least 20 patients with inoperable PDA and who are positive for CA19.9 pancreatic tumor marker. The presence of higher than normal levels of CA19.9 is the sole inclusion criteria. Patients will be given one tablet of V3-P daily and followed for three months.

Conditions

• Pancreatic Cancer Non-resectable

Interventions

Type	Name	Description
BIOLOGICAL	V3-P	one tablet of V3-P given once daily for 2 months

Timeline

• Start date: 2017-05-01
• Primary completion: 2020-02-28
• Completion: 2020-12-31
• First posted: 2017-05-24
• Last updated: 2019-08-30

Locations

2 sites across 1 country: Mongolia