Open Label Immunotherapy Trial of Inoperable Pancreatic Cancer (V3-P)

Immunitor

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Pancreatic Cancer Non-resectable

Treatments: Biological: V3-P

Study type: Interventional

Funder types: Industry

Identifiers

NCT03165591

Panc-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of inoperable pancreatic cancer
• higher than normal of serum CA19.9 tumor marker levels (40 IU/ml)
• must be able to swallow tablets

Exclusion criteria

• negative for CA19.9
• pregnant, breast feeding women
• unwillingness to provide written consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Experimental

Experimental group

Description:

Daily tablet of V3-P given orally for 2 months

Treatment:

Biological: V3-P