Study To Evaluate The Safety, Tolerability And Immunogenicity Of 4 mg Of ITI-3000 In Patients With Polyomavirus-Positive Merkel Cell Carcinoma (MCC)
VG
EW
Overseen ByElizabeth Walsh
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Immunomic Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
This trial tests a new vaccine called ITI-3000 in patients with a specific type of skin cancer who have finished standard treatments and currently show no signs of active disease. The vaccine aims to help their immune systems recognize and attack any remaining cancer cells.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on ongoing immunosuppressive therapy, you may not be eligible, except for low-dose topical, nasal, or inhaled steroids.
What safety data exists for ITI-3000 or similar treatments?
Eligibility Criteria
Inclusion Criteria
Participant has adequate hepatic function, as evidenced by a total bilirubin ≤ 1.5 times the ULN, aspartate transaminase (AST), and/or alanine transaminase (ALT) ≤ 3 times the ULN.
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.
Age ≥ 18 years.
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Exclusion Criteria
Participant with CLL-associated MCC.
Participant has a significant medical illness or abnormal laboratory finding that, in the Investigator's opinion, would increase the risk of participating in this study.
You lost more than 10% of your body weight in the last month without any apparent reason.
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a single 4 mg dose of the DNA vaccine ITI-3000
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety, tolerability, and immunologic response to the ITI-3000 vaccine
12 months
Multiple visits (in-person and virtual)
Treatment Details
Interventions
- ITI-3000
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Participants With Polyomavirus-Positive Merkel Cell Carcinoma (MCC)Experimental Treatment1 Intervention
Eight participants with MCC (\> 1.0 years since definitive treatment or participants who had recurrence \>2 years since evidence of disease) and NEAD
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Who Is Running the Clinical Trial?
Immunomic Therapeutics, Inc.
Lead Sponsor
Trials
9
Recruited
480+
Findings from Research
In a study involving 104 cancer patients treated with immune checkpoint inhibitors, self-reported questionnaires effectively identified over 50% of clinician-reported immune-related adverse events (irAE) related to gastrointestinal, lung, endocrine, and skin issues.
Specific questions about 'weight change' and 'insomnia' were particularly useful in increasing the detection rate of irAE, highlighting the potential for developing a more effective self-reporting tool for monitoring patients undergoing ICI therapy.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Questionnaire-based detection of immune-related adverse events in cancer patients treated with PD-1/PD-L1 immune checkpoint inhibitors.Griewing, LM., Schweizer, C., Schubert, P., et al.[2023]
A retrospective analysis of adverse events related to PD-1/PD-L1 inhibitors revealed a significant association between Pembrolizumab and hepatitis B reactivation (HBVr), with a reporting odds ratio of 2.32, indicating a higher risk compared to other treatments.
No cases of HBVr were reported with Ipilimumab or Avelumab, suggesting that not all immune checkpoint inhibitors carry the same risk, highlighting the need for further prospective studies to confirm these findings.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Hepatitis B Virus Reactivation in Cancer Patients Treated With Immune Checkpoint Inhibitors.Burns, EA., Muhsen, IN., Anand, K., et al.[2023]
In a study of 92 patients experiencing immune-related adverse events (irAEs) after immune checkpoint inhibitor therapy, 73% showed significant improvement or resolution of their symptoms after treatment with anti-IL-6R antibodies, such as tocilizumab, within a median of 2 months.
The overall tumor response rate remained stable at 66% before and after anti-IL-6R treatment, indicating that this therapy effectively manages irAEs without compromising the effectiveness of cancer treatment.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Selective immune suppression using interleukin-6 receptor inhibitors for management of immune-related adverse events.Fa'ak, F., Buni, M., Falohun, A., et al.[2023]
References
Questionnaire-based detection of immune-related adverse events in cancer patients treated with PD-1/PD-L1 immune checkpoint inhibitors. [2023]
A systematic review of immune-related adverse event reporting in clinical trials of immune checkpoint inhibitors. [2022]
Hepatitis B Virus Reactivation in Cancer Patients Treated With Immune Checkpoint Inhibitors. [2023]
Selective immune suppression using interleukin-6 receptor inhibitors for management of immune-related adverse events. [2023]
Adverse events of immune checkpoint inhibitors for patients with digestive system cancers: A systematic review and meta-analysis. [2022]
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