Merkel Cell Carcinoma (MCC)
MCC is a rare, aggressive cancer with an estimated 2,500 cases per year in the US with a high rate of recurrence following initial surgery. 80% of all MCC recurrences occur in the first two years after diagnosis. The medical need for these patients is very high and improvements to the standard of care are critical.
Merkel cell carcinoma (MCC) is associated with the newly discovered Merkel cell polyomavirus (MCPyV)
MCC and Merkel Cell Polyomavirus
The association of Merkel cell carcinoma and Merkel cell polyomavirus
In 2008, the Merkel cell polyomavirus (MCPyV) was discovered by the University of Pittsburgh laboratory of Drs Patrick Moore & Yuan Chang and found to be frequently present in MCC tumors.7 The virus was found in 8 of 10 tumors tested, and was associated with the DNA of the tumor cells in such a way to suggest that it is involved in the development of MCC. Since then, many studies have validated this initial report, finding MCPyV in the vast majority (about 80%) of MCC patients.8 9 Studies now show that the majority of people have been exposed to MCPyV by adulthood, but it appears that the virus does not cause any symptoms except in the very rare situations in which it leads to MCC (Nicol 2013, others).
Other Publications:
- Merkel cell polyomavirus and associated Merkel cell carcinoma (Science Direct – June 2022)
- Merkel Cell Polyomavirus and Merkel Cell Carcinoma (National Library of Medicine – 2017 Sep 11.)
- Merkel cell polyomavirus and Merkel cell carcinoma (National Library of Medicine – 2020 Jul 3)
- Merkel Cell Carcinoma & Merkel Cell Polyoma Virus (Center for Emerging and Re-Emerging Infectious Diseases)
Vaccine Therapy for the Treatment of MCC
The vaccine used in this clinical trial leverages ITI’s investigational lysosomal targeting technology in the context of pDNA. ITI-3000 is a DNA vaccine (L-H LT S220A) which contains sequences for both LAMP1 and LTS220A, the truncated form of the LT antigen of MCPyV with a detoxifying serine to alanine mutation at position 220
General Protocol
Polyomavirus-positive MCC participants are dosed with 4 mg of the DNA vaccine ITI-3000 after they have completed standard of care (SOC) surgical and/or radiation therapy at least 1 year prior to enrollment in the study and have no evidence of active disease (NEAD)
Official Title:
Study To Evaluate The Safety, Tolerability And Immunogenicity Of 4 mg Of ITI-3000 In Patients With Polyomavirus-Positive Merkel Cell Carcinoma (MCC)
Summary:
This Phase I clinical trial will evaluate the safety, tolerability, and immunogenicity of 4 mg doses of ITI-3000 in participants with polyomavirus-positive Merkel cell carcinoma (MCC).
Description:
This is a single dose design examining 4 mg dose of the DNA vaccine ITI-3000 in participants who were diagnosed with polyomavirus-positive MCC, histologically confirmed by an expert pathologist on standard clinical staining, that may have been supplemented by specific staining for Cytokeratin 20 (CK20) and/or other markers used to distinguish MCC.
Evidence of Merkel cell polyomavirus (MCPyV) in the tumor at initial presentation (pre-therapy) can be provided by a positive anti-MCPyV oncoprotein antibody AMERK Test.
Participants in the study are those who are both diagnosed and have completed standard of care (SOC) surgical and/or radiation therapy at least 1 year prior to enrollment in the study and have no evidence of active disease (NEAD). Participants those who were previously diagnosed with MCC, and had recurrence and also exhibited no evidence of active disease (NEAD) for more than 2 years prior to enrollment in the study.
NEAD is confirmed by physical examination, a negative AMERK test (<74 STU) in participants with a prior positive AMERK test, or significantly decreased, stable AMERK titers in 2 or more consecutive draws compared to prior positive AMERK test at the time of diagnosis, in the setting of a negative computed tomography (CT) scan of the chest, abdomen and pelvis or PET-CT within 3 months of enrollment into the study.
Patients will be enrolled at 4 mg total DNA dose to assess safety, tolerability, and immunologic response to the ITI-3000 vaccine.
ClinicalTrials.gov Identifier: NCT05422781
More information about this trial can be found here.
Patient Resources
The patient resources section is intended to provide a list of merkel cell carcinoma and other information sources dedicated to skin cancer education, research and support.