Open Label Immunotherapy Trial of Inoperable Pancreatic Cancer

NCT ID: NCT03165591

Last Updated: 2019-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatic Cancer Non-resectable

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental

Daily tablet of V3-P given orally for 2 months

Group Type EXPERIMENTAL

V3-P

Intervention Type BIOLOGICAL

one tablet of V3-P given once daily for 2 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

V3-P

one tablet of V3-P given once daily for 2 months

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

oral tableted therapeutic vaccine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Immunitor LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Allen Bain, PhD

Role: STUDY_CHAIR

Immunitor Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Immunitor LLC

Ulaanbaatar, , Mongolia

Site Status RECRUITING

National Cancer Center

Ulaanbaatar, , Mongolia

Site Status ENROLLING_BY_INVITATION

Countries

Review the countries where the study has at least one active or historical site.

Mongolia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

aldar Bourinbaiar, MD/PhD, PhD

Role: CONTACT

+976-95130306

Marina Tarakanovskaya, MD

Role: CONTACT

+976-95130306

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Aldar Bourinbaiar, MD

Role: primary

97695130306

Marina Tarakanovskaya, MD

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 28443252 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Panc-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.