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Status unknownNCT03165591V3-PUpdated Aug 30, 2019

Open Label Immunotherapy Trial of Inoperable Pancreatic Cancer

A Phase 1/2 interventional study of V3-P in Pancreatic Cancer Non-resectable, sponsored by Immunitor LLC. Status unknown at 2 sites in Mongolia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-30.

Sponsored by Immunitor LLC · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pancreatic Cancer Non-resectable
03

In context

Pancreatic Neoplasms

3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.

This study's planned enrollment of 30 is below the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Immunitor LLC is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Experimental

    Daily tablet of V3-P given orally for 2 months

    Biological: V3-P

Interventions

  • BiologicalV3-P

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

    Also known as: oral tableted therapeutic vaccine

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What researchers measure

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.

    Time frame: 3 months

Secondary outcomes

  1. Safety of V3-P

    Toxicity or adverse side effects, such as diarrhea and vomiting, will be graded according to accepted standards, e.g., NCI CTEP CTCAE.

    Time frame: 3 months

  2. Effect of V3-P on sugar and bilirubin levels

    Monthly evaluation of fasting glucose and bilirubin levels as a surrogate for pancreatic function

    Time frame: 3 months

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Study locations

2 of 2 sites recruiting
  • Immunitor LLC
    Ulaanbaatar, Mongolia
    Recruiting
  • National Cancer Center
    Ulaanbaatar, Mongolia
    Enrolling by invitation
08

References and documents

Publications

  • 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. PubMed 28443252 ↗

Individual participant data

Plan to share: Undecided — The data will be shared with other researchers upon request on study conclusion

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2017 (actual). Primary completion is estimated for Feb 2020, 33 months after the start.

Of 115 industry-sponsored phase 1/2 interventional studies under Pancreatic Neoplasms, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 88. This study's planned 33 months is below that.

Counting every sponsor, half of 209 studies reached it within 51 months; a quarter within 36 and three quarters within 89.

How these figures are worked out, and which studies are left out of them.

Registered
May 18, 2017
First posted
May 24, 2017
StartActual
May 1, 2017
Primary completionEst.
Feb 28, 2020
CompletionEst.
Dec 31, 2020
Last update
Aug 30, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03165591
Lead sponsor
Immunitor LLC
Responsible party
Sponsor
First posted
May 24, 2017
Start date
May 1, 2017
Primary completion
Feb 28, 2020 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Aug 30, 2019

Study contacts

aldar Bourinbaiar, MD/PhD, PhD
Contact
immunitor@gmail.com
+976-95130306
Marina Tarakanovskaya, MD
Contact
marinatarakanovskaya@yahoo.com
+976-95130306
Allen Bain, PhD
study chair · Immunitor Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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