Lymphocytic LeukemiaPhase 1NCT03219450
A Personalized Neoantigen Cancer Vaccine in Treatment Naïve, Asymptomatic Patients With IGHV Unmutated CLL.
A Phase 1 study testing NeoVax, Cyclophosphamide and Pembrolizumab in people with Lymphocytic Leukemia, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This research study is studying a novel type of CLL vaccine as a possible treatment for chronic lymphocytic leukemia (CLL) The names of the study interventions involved in this study are: Personalized NeoAntigen Vaccine Poly-ICLC Cyclophosphamide Pembrolizumab Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphocytic Leukemia
- What is being tested?
- NeoVax, Cyclophosphamide and Pembrolizumab
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2021to 31 Jul 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Diagnosis of CLL as per IWCLL 2018 criteria
- Patient's CLL must have an unmutated immunoglobulin heavy chain variable (IGHV) region gene, defined as < 2% mutated compared to germline.
- Patient must have had no history of CLL-directed therapy due to meeting IWCLL 2018 criteria; no present indication for treatment by iwCLL 2018 criteria; and in the opinion of the treating investigator be anticipated not to require CLL-directed treatment within the next 6 months.
- Patient must have measurable disease (absolute lymphocyte count > 10K/uL or total white blood cell count ≥ 20K/uL of peripheral blood).
- Patient must have had at least two other absolute lymphocyte counts (ALC) measured since diagnosis of CLL that are at least 2 weeks apart and at least 2 months prior to the one used for initial registration.
- Age ≥ 18 years.
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- ECOG performance status 0 or 1
- Participants must have normal organ and marrow function as defined below:
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
- absolute neutrophil count ≥1000 cells/μL
- The effects of NeoVax and poly-ICLC on the developing human fetus are unknown. For this reason, women of childbearing potential (WOCBP) must have a negative pregnancy test (minimum sensitivity 25 IU/L or equivalent of HCG) before entry onto the trial and within 7 days prior to start of study medication. It is the investigators' responsibility to repeat the pregnancy test should start of treatment be delayed.
- Female patients enrolled in the study, who are not free from menses for >2 years, post hysterectomy / oophorectomy, or surgically sterilized, must be willing to use either 2 adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy or to abstain from sexual activity throughout the study, starting with visit 1 through 4 weeks after the last dose of study therapy. Approved contraceptive methods include for example; intra uterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, or female condom with spermicide. Spermicides alone are not an acceptable method of contraception.
- Patient is agreeable to allow tumor (from peripheral blood) and normal tissue (from saliva) samples to be submitted for complete exome and transcriptome sequencing.
- Ability to understand and the willingness to sign a written informed consent document.
- At least 7 immunizing peptides can be designed.
- Continue to meet inclusion and exclusion criteria for Screening Registration.
Who cannot join
- Prior therapy for CLL that met IW-CLL treatment criteria, including chemotherapy, targeted therapies (e.g. that antagonize B cell receptor signaling), or immunotherapy (including but not limited to monoclonal antibodies); or radiotherapy or hormonal therapy within the last 2 years of screening registration.
- Participants who are receiving any other investigational agents.
- Previous bone marrow or stem cell transplant
- Concomitant therapy with immunosuppressive or immunomodulatory agents; chronic use of systemic corticosteroids. Previous history of corticosteroid use is acceptable. Use of corticosteroids after initial registration is acceptable if tapered at least one week before NeoVax administration.
- Use of a non-oncology vaccine therapy for prevention of infectious diseases within 2 weeks of any NeoVax administration.
- History of severe allergic reactions attributed to any vaccine therapy for the prevention of infectious diseases.
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- Participants who have never received the tetanus vaccine.
- Active, known, or suspected autoimmune disease or immunosuppressive conditions with the exception of vitiligo, type 1 diabetes, residual autoimmune-related hypothyroidism requiring hormone replacement, or psoriasis not requiring systemic treatment.
- Uncontrolled autoimmune cytopenia.
- No lymph node > 5 cm by CT scan (measured as long axis).
- Del(17p) by fluorescence in situ hybridization in ≥ 10% of CLL cells analyzed
- Any documented transformation of CLL (i.e. Richter's Syndrome).
- Lymphocyte doubling time (LDT) < 6 months in patients with WBC > 30,000/uL. Factors contributing to lymphocytosis other than CLL (e.g. infections) should be excluded when calculating the LDT1.
- Serum immunoglobulin level <400 mg/dL or currently requiring chronic intravenous immunoglobulin G (IVIG)
- Known chronic infections with HIV, hepatitis B or C (see Study Calendar in Section 10 for screening assays).
- Has received prior therapy with an anti-PD1, anti PD-L1, or anti PD-L2 agent.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.
- Any underlying medical condition, psychiatric condition or social situation that in the opinion of the investigator would compromise study administration as per protocol or compromise the assessment of AEs.
- Pregnant women are excluded from this study because personalized neoantigen peptides and poly-ICLC are agents with unknown risks to the developing fetus. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with personalized neoantigen peptides and poly-ICLC, nursing women are excluded from this study.
- Individuals with history of an invasive malignancy are ineligible except for the following circumstances: a) individuals with a history of invasive malignancy are eligible if they have been disease -free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; b) individuals with the following cancers are eligible if diagnosed and treated: carcinoma in situ of the breast, oral cavity or cervix and basal cell or squamous cell carcinoma of the skin; c) individuals with prostate cancer managed with active surveillance that is not expected to limit their survival to <10 years.
- Participants with known CNS involvement should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to poly-ICLC.
- HIV-positive participants on combination antiretroviral therapy are ineligible because assessment of immunologic endpoints may be confounded by HIV-induced alterations in patient immune status and function. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Inhye E Ahn, MD
Inhye Ahn, MD
About this study
Official title: A Pilot Study of a Personalized Neoantigen Cancer Vaccine With and Without Low-Dose Cyclophosphamide or Pembrolizumab in Treatment Naïve, Asymptomatic Patients With IGHV Unmutated Chronic Lymphocytic Leukemia.
This research study is studying a novel type of CLL vaccine as a possible treatment for chronic lymphocytic leukemia (CLL)
The names of the study interventions involved in this study are:
- Personalized NeoAntigen Vaccine
- Poly-ICLC
- Cyclophosphamide
- Pembrolizumab
Read the detailed description
This research study evaluates the feasibility and tolerability of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied and that research doctors are trying to find more about it. It also means that the FDA (US Food and Drug Administration) has not approved the Personalized Neoantigen Cancer Vaccine for any use in patients, including people with CLL.
This is the first time NeoVax vaccine will be given in combination with cyclophosphamide and Pembrolizumab in humans.
The purpose of this study is to determine if it is possible to make and safely administer a vaccine against CLL. The investigators plan to analyze the specific genetic characteristics (mutations) of the participant's own CLL and use that information to produce proteins that may help the immune system recognize and fight CLL cells.
This vaccine is also being tested in clinical trials in patients with advanced melanoma (a type of skin cancer) or glioblastoma (a type of brain cancer). The current study will examine the ability of the vaccine to stimulate the immune system when given at several different timepoints, and will examine the participant blood cells for signs that the CLL has changed or decreased.
CLL cells will be obtained from bone marrow biopsy and blood draws. The genetic material contained in the CLL cells will be examined for the presence of tumor-specific mutations. This information will be used to prepare small protein fragments, which are called "peptides." The vaccine will consist of up to 20 of these peptides as well as a drug called Poly-ICLC. A peptide from the tetanus vaccine may also be included to boost the immune response. A third of the patients enrolled in this trial will receive the personalized neoantigen vaccine. Another third of the patients will also receive low doses of a chemotherapy drug called cyclophosphamide in combination of personalized neoantigen vaccine. The last third of patients enrolled in this study will receive the personalized neoantigen vaccine in combination with low dose cyclophosphamide and a drug called Pembrolizumab.
Poly-ICLC (also called Hiltonol) is an experimental "viral mimic" and an activator of immunity. Poly-ICLC binds proteins on the surface of certain immune cells to make it appear as if a virus is present. When the cells detect the vaccine, they think it is a virus and turn on the immune system. Poly-ICLC will be mixed with NeoAntigen peptides and administered as an injection given underneath the skin. Poly-ICLC is an investigational drug, meaning the FDA has not approved it as a treatment for any disease.
Cyclophosphamide (also called Cytoxan) is a chemotherapy drug used to treat many cancers, including CLL. At the much lower dose used in this study, it is an investigational drug to help the immune cells to be better at attacking cancer cells.
Pembrolizumab is a monoclonal antibody used to treat other types of cancer and information from these studies suggests that it may be beneficial in CLL.
- Conditions
- Lymphocytic Leukemia
- Being tested
- NeoVax, Cyclophosphamide, Pembrolizumab
- Keywords
- Leukemia, Lymphocytic Leukemia
- Medical subject headings
- Leukemia, Lymphoid, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoVaxDrug
Also called Neoantigen vaccine
It stimulates the immune system to attack cancer cells.
CyclophosphamideDrug
Also called Cytoxan
It is a chemotherapy drug used to treat many cancers. At low doses, it is an investigational drug to help the immune cells to be better at attacking cancer cells while avoiding chemotherapy toxicity.
PembrolizumabDrug
Also called Keytruda
Is a monoclonal antibody that helps the immune cells to be better at attacking cancer cells.
| Study group | Role | What they receive |
|---|---|---|
| NeoVax | Experimental | * NeoVax will be administered in a priming and booster phase.
* The priming shots will comprise days 1, 4, 8, 15, and 22.
* Booster shots will be given on days 78 and 134. Receives: Drug: NeoVax |
| Neovax + Low-dose cyclophosphamide | Experimental | * NeoVax will be administered in a priming and booster phase.
* The priming shots will comprise days 1, 4, 8, 15, and 22.
* Booster shots will be given on days 78 and 134.
* Low dose cyclophosphamide is administered twice daily on weeks -2, 1, 3, 5 Receives: Drug: NeoVax; Drug: Cyclophosphamide |
| Neovax + Low-dose cyclophosphamide + Pembrolizumab | Experimental | * NeoVax will be administered in a priming and booster phase.
* The priming shots will comprise days 1, 4, 8, 15, and 22.
* Booster shots will be given on days 78 and 134.
* Low dose cyclophosphamide is administered twice daily on weeks -2, 1, 3, 5
* Pembrolizumab will be administered starting on Week 12 Day 78 and for up to 17 cycles (approximately 1 year). Receives: Drug: NeoVax; Drug: Cyclophosphamide; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of neoantigen identification
The proportion of all enrolled patients for whom sequencing and analysis leads to identification of at least 7 actionable peptides to initiate vaccine production
Measured: 6 months
Feasibility of vaccine generation
Of the patients who generate at least 7 actionable peptides, the proportion for whom the time from sample collection to vaccine availability is less than 12 weeks
Measured: 6 months
Safety of NeoVax
The number of patients with treatment-limiting toxicities based on NCI CTCAE v5.0
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 posted17 Jul 2017
- Study start18 Aug 2021
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oncovir, Inc., BioNTech SE, Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Inhye Ahn, Dana-Farber Cancer Institute
- Investigators
- Inhye Ahn, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219450
- Sponsor's protocol ID
- 17-105
- Status last verified
- May 2026
- First submitted
- 6 Jul 2017
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Personalized Neoantigen Cancer Vaccine With and Without Low-Dose Cyclophosphamide or Pembrolizumab in Treatment Naïve, Asymptomatic Patients With IGHV Unmutated Chronic Lymphocytic Leukemia.
- ClinicalTrials.gov ID
- NCT03219450
- Acronym / sponsor ID
- 17-105
- Conditions
- Lymphocytic Leukemia
- Keywords
- Leukemia, Lymphocytic Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Oncovir, Inc., BioNTech SE, Merck Sharp & Dohme LLC
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 17 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is studying a novel type of CLL vaccine as a possible treatment for chronic lymphocytic leukemia (CLL)
The names of the study interventions involved in this study are:
- Personalized NeoAntigen Vaccine
- Poly-ICLC
- Cyclophosphamide
- Pembrolizumab
Detailed description
This research study evaluates the feasibility and tolerability of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied and that research doctors are trying to find more about it. It also means that the FDA (US Food and Drug Administration) has not approved the Personalized Neoantigen Cancer Vaccine for any use in patients, including people with CLL.
This is the first time NeoVax vaccine will be given in combination with cyclophosphamide and Pembrolizumab in humans.
The purpose of this study is to determine if it is possible to make and safely administer a vaccine against CLL. The investigators plan to analyze the specific genetic characteristics (mutations) of the participant's own CLL and use that information to produce proteins that may help the immune system recognize and fight CLL cells.
This vaccine is also being tested in clinical trials in patients with advanced melanoma (a type of skin cancer) or glioblastoma (a type of brain cancer). The current study will examine the ability of the vaccine to stimulate the immune system when given at several different timepoints, and will examine the participant blood cells for signs that the CLL has changed or decreased.
CLL cells will be obtained from bone marrow biopsy and blood draws. The genetic material contained in the CLL cells will be examined for the presence of tumor-specific mutations. This information will be used to prepare small protein fragments, which are called "peptides." The vaccine will consist of up to 20 of these peptides as well as a drug called Poly-ICLC. A peptide from the tetanus vaccine may also be included to boost the immune response. A third of the patients enrolled in this trial will receive the personalized neoantigen vaccine. Another third of the patients will also receive low doses of a chemotherapy drug called cyclophosphamide in combination of personalized neoantigen vaccine. The last third of patients enrolled in this study will receive the personalized neoantigen vaccine in combination with low dose cyclophosphamide and a drug called Pembrolizumab.
Poly-ICLC (also called Hiltonol) is an experimental "viral mimic" and an activator of immunity. Poly-ICLC binds proteins on the surface of certain immune cells to make it appear as if a virus is present. When the cells detect the vaccine, they think it is a virus and turn on the immune system. Poly-ICLC will be mixed with NeoAntigen peptides and administered as an injection given underneath the skin. Poly-ICLC is an investigational drug, meaning the FDA has not approved it as a treatment for any disease.
Cyclophosphamide (also called Cytoxan) is a chemotherapy drug used to treat many cancers, including CLL. At the much lower dose used in this study, it is an investigational drug to help the immune cells to be better at attacking cancer cells.
Pembrolizumab is a monoclonal antibody used to treat other types of cancer and information from these studies suggests that it may be beneficial in CLL.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NeoVax | Experimental | Drug: NeoVax* NeoVax will be administered in a priming and booster phase. * The priming shots will comprise days 1, 4, 8, 15, and 22. * Booster shots will be given on days 78 and 134. |
| Neovax + Low-dose cyclophosphamide | Experimental | Drug: NeoVax, Drug: Cyclophosphamide* NeoVax will be administered in a priming and booster phase. * The priming shots will comprise days 1, 4, 8, 15, and 22. * Booster shots will be given on days 78 and 134. * Low dose cyclophosphamide is administered twice daily on weeks -2, 1, 3, 5 |
| Neovax + Low-dose cyclophosphamide + Pembrolizumab | Experimental | Drug: NeoVax, Drug: Cyclophosphamide, Drug: Pembrolizumab* NeoVax will be administered in a priming and booster phase. * The priming shots will comprise days 1, 4, 8, 15, and 22. * Booster shots will be given on days 78 and 134. * Low dose cyclophosphamide is administered twice daily on weeks -2, 1, 3, 5 * Pembrolizumab will be administered starting on Week 12 Day 78 and for up to 17 cycles (approximately 1 year). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Diagnosis of CLL as per IWCLL 2018 criteria
- Patient's CLL must have an unmutated immunoglobulin heavy chain variable (IGHV) region gene, defined as < 2% mutated compared to germline.
- Patient must have had no history of CLL-directed therapy due to meeting IWCLL 2018 criteria; no present indication for treatment by iwCLL 2018 criteria; and in the opinion of the treating investigator be anticipated not to require CLL-directed treatment within the next 6 months.
- Patient must have measurable disease (absolute lymphocyte count > 10K/uL or total white blood cell count ≥ 20K/uL of peripheral blood).
- Patient must have had at least two other absolute lymphocyte counts (ALC) measured since diagnosis of CLL that are at least 2 weeks apart and at least 2 months prior to the one used for initial registration.
Key exclusion criteria (23 listed)
- Prior therapy for CLL that met IW-CLL treatment criteria, including chemotherapy, targeted therapies (e.g. that antagonize B cell receptor signaling), or immunotherapy (including but not limited to monoclonal antibodies); or radiotherapy or hormonal therapy within the last 2 years of screening registration.
- Participants who are receiving any other investigational agents.
- Previous bone marrow or stem cell transplant
- Concomitant therapy with immunosuppressive or immunomodulatory agents; chronic use of systemic corticosteroids. Previous history of corticosteroid use is acceptable. Use of corticosteroids after initial registration is acceptable if tapered at least one week before NeoVax administration.
- Use of a non-oncology vaccine therapy for prevention of infectious diseases within 2 weeks of any NeoVax administration.
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 |
|---|---|---|
| NeoVaxAlso: Neoantigen vaccineIt stimulates the immune system to attack cancer cells. | Drug | NeoVax, Neovax + Low-dose cyclophosphamide, Neovax + Low-dose cyclophosphamide + Pembrolizumab |
| CyclophosphamideAlso: CytoxanIt is a chemotherapy drug used to treat many cancers. At low doses, it is an investigational drug to help the immune cells to be better at attacking cancer cells while avoiding chemotherapy toxicity. | Drug | Neovax + Low-dose cyclophosphamide, Neovax + Low-dose cyclophosphamide + Pembrolizumab |
| PembrolizumabAlso: KeytrudaIs a monoclonal antibody that helps the immune cells to be better at attacking cancer cells. | Drug | Neovax + Low-dose cyclophosphamide + Pembrolizumab |
Primary outcome
Feasibility of neoantigen identification
Time frame: 6 months
The proportion of all enrolled patients for whom sequencing and analysis leads to identification of at least 7 actionable peptides to initiate vaccine production
Feasibility of vaccine generation
Time frame: 6 months
Of the patients who generate at least 7 actionable peptides, the proportion for whom the time from sample collection to vaccine availability is less than 12 weeks
Safety of NeoVax
Time frame: 1 year
The number of patients with treatment-limiting toxicities based on NCI CTCAE v5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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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.
Inhye Ahn, MD principal investigator
Dana-Farber Cancer Institute
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 NeoVax, Cyclophosphamide and Pembrolizumab in people with Lymphocytic Leukemia, run by Dana-Farber Cancer Institute 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 17 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 28 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oriol Olive Noguer (617-632-2581, Oriol_Olive@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of neoantigen identification (time frame: 6 months). The study lists 3 primary outcomes in all. 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 28 May 2026.