Open Label Immunotherapy Trial of Inoperable Pancreatic Cancer
V3-P
Open Label Phase II Immunotherapy Trial of Inoperable Pancreatic Cancer
1 other identifier
interventional
30
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2017
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 18, 2017
CompletedFirst Posted
Study publicly available on registry
May 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedAugust 30, 2019
August 1, 2019
2.8 years
May 18, 2017
August 29, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Effect of V3-P on tumor burden
Changes in CA19.9 tumor marker induced by daily dose of oral vaccine V3-P in an open label trial in patients with inoperable pancreatic cancer.
3 months
Secondary Outcomes (2)
Safety of V3-P
3 months
Effect of V3-P on sugar and bilirubin levels
3 months
Study Arms (1)
Experimental
EXPERIMENTALDaily tablet of V3-P given orally for 2 months
Interventions
one tablet of V3-P given once daily for 2 months
Eligibility Criteria
You may qualify if:
- diagnosis of inoperable pancreatic cancer
- higher than normal of serum CA19.9 tumor marker levels (40 IU/ml)
- must be able to swallow tablets
You may not qualify if:
- negative for CA19.9
- pregnant, breast feeding women
- unwillingness to provide written consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Immunitor LLClead
Study Sites (2)
Immunitor LLC
Ulaanbaatar, Mongolia
National Cancer Center
Ulaanbaatar, Mongolia
Related Publications (1)
Tarakanovskaya MG, Chinburen J, Batchuluun P, Munkhzaya C, Purevsuren G, Dandii D, Hulan T, Oyungerel D, Kutsyna GA, Reid AA, Borisova V, Bain AI, Jirathitikal V, Bourinbaiar AS. Open-label Phase II clinical trial in 75 patients with advanced hepatocellular carcinoma receiving daily dose of tableted liver cancer vaccine, hepcortespenlisimut-L. J Hepatocell Carcinoma. 2017 Apr 12;4:59-69. doi: 10.2147/JHC.S122507. eCollection 2017.
PMID: 28443252BACKGROUND
Study Officials
- STUDY CHAIR
Allen Bain, PhD
Immunitor Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2017
First Posted
May 24, 2017
Study Start
May 1, 2017
Primary Completion
February 28, 2020
Study Completion
December 31, 2020
Last Updated
August 30, 2019
Record last verified: 2019-08