Phase 1
N=25
Personalized Immunotherapy in Adults With Advanced Cancers Immunotherapy in Adults With Advanced Cancers
Advanced Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03568058 ↗Enrolled (actual)
25
Serious AEs
20.0%
Results posted
Mar 2026
Primary outcome: Primary: Treatment-related Adverse Events — 19; 103; 85 Number of Treatment-related Adverse Even
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Personalized Vaccine (Drug); Pembrolizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aaron Miller
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment-related Adverse Events |
19; 103; 85 | — |
| SECONDARY Overall Response |
0; 0; 0; 0 | — |
Summary
The purpose of this study is to determine if it is possible to make and administer safely a 'personalized' vaccine to treat patients that have been diagnosed with advanced cancer and are not candidates for curative therapy.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03568058). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.