Custom-Made cancer vaccine tested in 25 patients
NCT ID NCT03568058
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a personalized vaccine could be safely made and given to 25 adults with advanced cancers that cannot be cured. The vaccine was custom-made for each person. The main goal was to check for side effects and see if the approach is feasible.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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25 people
The number who actually took part.
- Started
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Jul 2018
- Finished
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Jan 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria * Histologically or cytologically documented incurable solid tumor \[excluding lymphoma\]. * Measurable disease as defined by RECIST 1.1 * Progressed on or be intolerant to therapies that are known to provide clinical benefit. * Non-measurable disease by RECIST 1.1 and high-risk (\>50% over 5 years) of mortality * ECOG Performance Status ≤ 1. * At least one tumor site accessible for biopsy. * Adequate organ function * Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Exclusion Criteria * Patient has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. * Known or suspected allergy or hypersensitivity to any component of vaccine. * Has a known history of Human Immunodeficiency Virus (HIV). * Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority. (Individuals who are hepatitis C antibody positive may be enrolled if negative viral load confirmed). * History of autoimmune disease including: inflammatory bowel disease (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitis (e.g. Wegener's granulomatosis); central nervous system or motor neuropathy considered of autoimmune origin (e.g. Guillain-Barré syndrome, myasthenia gravis, multiple sclerosis). Individuals with vitiligo, Sjogren's Syndrome, interstitial cystitis, Graves' or Hashimoto's Disease, celiac disease, DM1, hypothyroidism stable on hormone replacement, or any autoimmune disease without symptoms and not requiring active therapy for at least 2 years will be allowed with Study Medical Monitor's approval. * Has a known history of active TB (Bacillus Tuberculosis). * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * History of receiving a solid organ transplant or allogeneic bone marrow transplant. * Unable or unwilling to withhold or discontinue any prohibited or restricted medications/procedures for the specified windows during the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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UCSD Medical Center
San Diego, California, 92103, United States
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