Advanced CancerPhase 1NCT03568058
Personalized Immunotherapy in Adults With Advanced Cancers Immunotherapy in Adults With Advanced Cancers
A Phase 1 study testing Personalized Vaccine and Pembrolizumab in people with Advanced Cancer, run by Aaron Miller at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Personalized Vaccine and Pembrolizumab
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2018to 27 Jan 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1b Safety and Feasibility Study of Personalized Immunotherapy in Adults With Advanced Cancers
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.
Read the detailed description
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.
This 'personalized' vaccine will use information gained from specific characteristics of your own cancer. It is known that cancer has mutations (changes in genetic material) that are specific to an individual and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune (protective) responses, which may help your body fight any tumor cells that could cause your cancer to come back in the future. The study will examine the safety of the vaccine when given at several time points and will examine your blood cells for signs that the vaccine induced an immune response.
The personalized vaccine will be given in combination with an anti-PD1 antibody, pembrolizumab, which is used with the intention to increase anti-cancer immunity (protection). Pembrolizumab is a type of drug that blocks certain proteins made by some types of immune system cells, such as T cells, and some cancer cells. These proteins help keep immune responses in check and can keep T cells from killing cancer cells. When these proteins are blocked, the "brakes" on the immune system are released and T cells are able to kill cancer cells better.
This personalized vaccine is considered experimental because this is not an FDA approved therapy for cancer.
Pembrolizumab is FDA approved for the treatment of melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), classical Hodgkin lymphoma (cHL), primary mediastinal large b-cell lymphoma (PMBCL), urothelial carcinoma, tumor mutational burden-high (TMB-H) cancer, cutaneous squamous cell carcinoma (cSCC), triple-negative breast cancer (TNBC), microsatellite instability-high (MSI-H) or mismatch repair deficient cancer, microsatellite instability-high or mismatch repair deficient colorectal cancer (CRC), gastric cancer, esophageal cancer, cervical cancer, and hepatocellular carcinoma (HCC), merkel cell carcinoma (MCC), renal cell carcinoma (RCC), endometrial carcinoma. Pembrolizumab is considered experimental (investigational) for the treatment of all other cancer types.
- Conditions
- Advanced Cancer
- Being tested
- Personalized Vaccine, Pembrolizumab
- Keywords
- immunotherapy, personalized cancer vaccine, personalized immunotherapy, pembrolizumab, Keytruda, cancer, neoantigen, solid tumor, vaccine
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized VaccineDrug
Vaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks.
PembrolizumabDrug
Also called Keytruda, Anti- PD-1
Pembrolizumab was administered intravenous (IV) infusion every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Personalized vaccine and anti- PD-1 administered concurrently at the start of study therapy. | Experimental | Personalized vaccine and anti- PD-1 administered concurrently at the start of study therapy. Personalized vaccine will be administered by subcutaneous injection. Vaccine will be administered every three weeks for a total of three doses. Vaccine may continue to be administered at 3 week intervals for an additional 9 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit. Receives: Drug: Personalized Vaccine; Drug: Pembrolizumab |
| Arm B: Anti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy. | Experimental | Anti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy. Personalized vaccine will be administered by subcutaneous injection. Vaccine will be administered every three weeks for a total of three doses. Vaccine may continue to be administered at 3 week intervals for an additional 9 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit. Receives: Drug: Personalized Vaccine; Drug: Pembrolizumab |
| Arm C: Personalized vaccine & anti- PD-1 administered concurrently in a boosted schedule | Experimental | Personalized vaccine and anti- PD-1 administered concurrently in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit. Receives: Drug: Personalized Vaccine; Drug: Pembrolizumab |
| Arm D: Personalized vaccine alone, in a boosted schedule at the start of study therapy. | Experimental | Personalized vaccine alone, in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit. Receives: Drug: Personalized Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related Adverse Events
Number of Treatment-related Adverse Events
Measured: 1 year
Secondary outcomes (1)
Overall Response
RECIST 1.1 - Overall Response
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start26 Jul 2018
- Primary completion12 Dec 2022
- Study completion27 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aaron Miller
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aaron Miller, University of California, San Diego
- Investigators
- Aaron Miller, MD, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568058
- Sponsor's protocol ID
- 180410
- Status last verified
- Mar 2026
- First submitted
- 13 Jun 2018
- Last updated
- 24 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Safety and Feasibility Study of Personalized Immunotherapy in Adults With Advanced Cancers
- ClinicalTrials.gov ID
- NCT03568058
- Acronym / sponsor ID
- 180410
- Conditions
- Advanced Cancer
- Keywords
- immunotherapy, personalized cancer vaccine, personalized immunotherapy, pembrolizumab, Keytruda, cancer, neoantigen, solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Aaron MillerUniversity, hospital or other
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 27 Jan 2025 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Posted 24 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
This 'personalized' vaccine will use information gained from specific characteristics of your own cancer. It is known that cancer has mutations (changes in genetic material) that are specific to an individual and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune (protective) responses, which may help your body fight any tumor cells that could cause your cancer to come back in the future. The study will examine the safety of the vaccine when given at several time points and will examine your blood cells for signs that the vaccine induced an immune response.
The personalized vaccine will be given in combination with an anti-PD1 antibody, pembrolizumab, which is used with the intention to increase anti-cancer immunity (protection). Pembrolizumab is a type of drug that blocks certain proteins made by some types of immune system cells, such as T cells, and some cancer cells. These proteins help keep immune responses in check and can keep T cells from killing cancer cells. When these proteins are blocked, the "brakes" on the immune system are released and T cells are able to kill cancer cells better.
This personalized vaccine is considered experimental because this is not an FDA approved therapy for cancer.
Pembrolizumab is FDA approved for the treatment of melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), classical Hodgkin lymphoma (cHL), primary mediastinal large b-cell lymphoma (PMBCL), urothelial carcinoma, tumor mutational burden-high (TMB-H) cancer, cutaneous squamous cell carcinoma (cSCC), triple-negative breast cancer (TNBC), microsatellite instability-high (MSI-H) or mismatch repair deficient cancer, microsatellite instability-high or mismatch repair deficient colorectal cancer (CRC), gastric cancer, esophageal cancer, cervical cancer, and hepatocellular carcinoma (HCC), merkel cell carcinoma (MCC), renal cell carcinoma (RCC), endometrial carcinoma. Pembrolizumab is considered experimental (investigational) for the treatment of all other cancer types.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A: Personalized vaccine and anti- PD-1 administered concurrently at the start of study therapy. | Experimental | Drug: Personalized Vaccine, Drug: PembrolizumabPersonalized vaccine and anti- PD-1 administered concurrently at the start of study therapy. Personalized vaccine will be administered by subcutaneous injection. Vaccine will be administered every three weeks for a total of three doses. Vaccine may continue to be administered at 3 week intervals for an additional 9 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit. |
| Arm B: Anti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy. | Experimental | Drug: Personalized Vaccine, Drug: PembrolizumabAnti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy. Personalized vaccine will be administered by subcutaneous injection. Vaccine will be administered every three weeks for a total of three doses. Vaccine may continue to be administered at 3 week intervals for an additional 9 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit. |
| Arm C: Personalized vaccine & anti- PD-1 administered concurrently in a boosted schedule | Experimental | Drug: Personalized Vaccine, Drug: PembrolizumabPersonalized vaccine and anti- PD-1 administered concurrently in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit. |
| Arm D: Personalized vaccine alone, in a boosted schedule at the start of study therapy. | Experimental | Drug: Personalized VaccinePersonalized vaccine alone, in a boosted schedule at the start of study therapy. Personalized vaccine will be administered by intramuscular injection. Vaccine will be administered three weekly priming vaccine doses, followed by six vaccine doses administered every three weeks. Vaccine may continue to be administered at 3 week intervals for an additional 18 doses if there is no evidence of disease progression. Treatment for up to 9 doses may continue past progression if the treating physician feels there is continued benefit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized VaccineVaccine was constructed for each subject that express multiple candidate tumor-derived neoantigens. Administered intramuscular injection every 3 weeks. | Drug | Arm A: Personalized vaccine and anti- PD-1 administered concurrently at the start of study therapy., Arm B: Anti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy., Arm C: Personalized vaccine & anti- PD-1 administered concurrently in a boosted schedule, Arm D: Personalized vaccine alone, in a boosted schedule at the start of study therapy. |
| PembrolizumabAlso: Keytruda, Anti- PD-1Pembrolizumab was administered intravenous (IV) infusion every 3 weeks. | Drug | Arm A: Personalized vaccine and anti- PD-1 administered concurrently at the start of study therapy., Arm B: Anti-PD-1 antibody for 6 weeks followed by personalized vaccine therapy., Arm C: Personalized vaccine & anti- PD-1 administered concurrently in a boosted schedule |
Primary outcome
Treatment-related Adverse Events
Time frame: 1 year
Number of Treatment-related Adverse Events
1 secondary outcome
Overall Response
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Miller, MD, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Personalized Vaccine and Pembrolizumab in people with Advanced Cancer, run by Aaron Miller at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-related Adverse Events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.