Open Label Immunotherapy Trial of Inoperable Pancreatic Cancer

NCT03165591 — Phase 1 / Phase 2, Unknown, 30 participants, Immunitor LLC

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Open Label Phase II Immunotherapy Trial of Inoperable Pancreatic Cancer

Registry	NCT03165591, acronym V3-P
Status	Unknown
Phase	Phase 1 / Phase 2
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	30 (Estimated)
Sponsor	Immunitor LLC (Industry)
Conditions	Pancreatic Cancer Non-resectable
Interventions	V3-P (Biological)
Dates	start 2017-05-01, primary completion 2020-02-28 (estimated), completion 2020-12-31 (estimated), first posted 2017-05-24, last updated 2019-08-30
Locations	2 sites in Mongolia

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Experimental	Experimental	Biological: V3-P	Daily tablet of V3-P given orally for 2 months

V3-P (Biological), also known as oral tableted therapeutic vaccine: one tablet of V3-P given once daily for 2 months

+Outcome measures

Primary outcomes

Effect of V3-P on tumor burden [3 months]: 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.

Secondary outcomes

Safety of V3-P [3 months]: Toxicity or adverse side effects, such as diarrhea and vomiting, will be graded according to accepted standards, e.g., NCI CTEP CTCAE.
Effect of V3-P on sugar and bilirubin levels [3 months]: Monthly evaluation of fasting glucose and bilirubin levels as a surrogate for pancreatic function

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (2)

Facility	City	Country	Status
Immunitor LLC	Ulaanbaatar	Mongolia	Recruiting
National Cancer Center	Ulaanbaatar	Mongolia	Enrolling by invitation

+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. PMID 28443252

+Investigators

Allen Bain, PhD, Study chair, Immunitor Inc.

My Notes

Public

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