Anatomic Stage I Breast Cancer AJCC v8Phase 2NCT04329065
Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer
A Phase 2 study testing pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine, Paclitaxel and Trastuzumab in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by University of Washington at 1 site in United States.
Trial summary
This phase II trial studies the immunologic response and side effects of using the WOKVAC vaccine in combination with chemotherapy and HER2-targeted monoclonal antibody therapy before surgery in treating patients with breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- What is being tested?
- pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine, Paclitaxel and Trastuzumab
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2022to 31 Dec 2027
- Phase
- Phase 2
- 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
- Patients must be at least >= 18 years of age
- Clinical stage I-III breast cancer, HER2+ (per American Society of Clinical Oncology [ASCO]/College of American Pathologists [CAP] guideline update, 2018), regardless of estrogen receptor (ER)/ progesterone receptor (PR) status and planning to undergo neoadjuvant therapy with either paclitaxel, trastuzumab, and pertuzumab (THP) or docetaxel, carboplatin, trastuzumab, and pertuzumab (TCHP)
- Patients who have received prior neoadjuvant chemotherapy are allowed but may only receive paclitaxel, trastuzumab, and pertuzumab for the duration the study
- Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- White blood cell (WBC) >= 3000/mm^3 (within 4 weeks of initiating study treatment)
- Lymphocyte count >= 500/mm^3 (within 4 weeks of initiating study treatment)
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- Absolute neutrophil count (ANC) >= 1,500/ uL (within 4 weeks of initiating study treatment)
- Platelets >= 75,000/ uL (within 4 weeks of initiating study treatment)
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert's syndrome in whom total bilirubin must be < 3.0 mg/dL (within 4 weeks of initiating study treatment)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x institutional upper limit of normal (ULN) (within 4 weeks of initiating study treatment)
- Creatinine =< 2.0 mg/dL or creatinine clearance > 30 ml/min (within 4 weeks of initiating study treatment)
- Left ventricular ejection fraction (LVEF) >= lower limit of normal for institution performing the multi-gated acquisition (MUGA) or echocardiogram (ECHO) done within 3 months of initiating study treatment
- Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative urine pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal. For both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last vaccine
- Ability to understand and willingness to sign a written informed consent document
Who cannot join
- Patients with any of the following cardiac conditions:
- Symptomatic restrictive cardiomyopathy
- Dilated cardiomyopathy
- Unstable angina within 4 months prior to enrollment
- New York Heart Association functional class III-IV heart failure on active treatment
- Symptomatic pericardial effusion
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- Uncontrolled autoimmune disease requiring active systemic treatment
- Known hypersensitivity reaction to the granulocyte-macrophage colony stimulating factor (GM-CSF) adjuvant; any known contra-indication to GM-CSF
- Pregnant or breast feeding
- Known human immunodeficiency virus (HIV)-positive
- History of uncontrolled diabetes
- Known current or a history of hepatitis B or C virus, including chronic and dormant states, unless disease has been treated and confirmed cleared
- Major surgery within the 4 weeks prior to initiation of study vaccine
- Current use of immunosuppressive agents or systemic corticosteroids. Topical, ocular, intra-articular, intranasal, inhalational corticosteroids (with minimal systemic absorption) are allowed. Patients who have received systemic corticosteroids =< 30 days prior to starting study drug will be excluded
- NOTE: Steroids given as supportive care for the neoadjuvant chemotherapy regimens is allowable per standard of care
- Patient is currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices, or investigational drug
- Patients may not be receiving any other investigational agents
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
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Jennifer Childs, 206-616-2305, childj@uw.edu
William Gwin
About this study
Official title: A Phase II Study of Concurrent WOKVAC Vaccination With Neoadjuvant Chemotherapy and HER2-Targeted Monoclonal Antibody Therapy
This phase II trial studies the immunologic response and side effects of using the WOKVAC vaccine in combination with chemotherapy and HER2-targeted monoclonal antibody therapy before surgery in treating patients with breast cancer. Vaccines like WOKVAC are made from tumor-associated antigens which may help the body build an effective immune response to kill tumor cells. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are forms of targeted therapy because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab and pertuzumab attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving the WOKVAC vaccine at the same time (concurrently) with paclitaxel, trastuzumab, and pertuzumab before surgery may kill more tumor cells.
Read the detailed description
OUTLINE:
Patients receive WOKVAC intradermally (ID) on day 13. Treatment repeats for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive paclitaxel via infusion on days 1, 8, and 15 or docetaxel intravenously (IV) and carboplatin IV on day 1, and trastuzumab IV and pertuzumab IV on day 1. The chemo and trastuzumab and pertuzumab will most likely be given by the patient's own oncologist per standard of care. Treatment repeats for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ultrasound imaging or magnetic resonance imaging and biopsy on study and blood sample collection throughout the study.
After completion of study treatment, patients are followed up annually for up to 5 years from enrollment.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- Being tested
- pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine, Paclitaxel, Trastuzumab, Pertuzumab, Docetaxel
- Keywords
- Breast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA VaccineBiological
Also called pUMVC3-IGFBP2-HER2-IGF1R, pUMVC3-IGFBP2-HER2-IGF1R Vaccine, WOKVAC, WOKVAC Vaccine
Given ID
PaclitaxelDrug
Also called Anzatax, Asotax, Bristaxol, Praxel
Given via infusion
TrastuzumabBiological
Also called Anti-c-erbB2 Monoclonal Antibody, Anti-ERB-2, Anti-erbB2 Monoclonal Antibody, Anti-HER2/c-erbB2 Monoclonal Antibody
Given IV
PertuzumabBiological
Also called 2C4 Antibody, Immunoglobulin G1, Anti-(Human V (Receptor)) (Human-Mouse Monoclonal 2C4 Heavy Chain), Disulfide with Human-Mouse Monoclonal 2C4 Kappa-Chain
Given IV
DocetaxelDrug
Also called RP-56976, RP56976, Taxotere, Taxotere Injection Concentrate
Given IV
CarboplatinDrug
Also called Paraplatin, Platinwas, Ribocarbo
Given IV
Ultrasound ImagingProcedure or surgery
Also called US
Undergo ultrasound imaging
Biopsy ProcedureProcedure or surgery
Also called Bx
Undergo biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection
Undergo blood sample collection
| Study group | Role | What they receive |
|---|---|---|
| Treatment (WOKVAC, paclitaxel, trastuzumab, pertuzumab) | Experimental | Patients receive WOKVAC ID on day 13. Treatment repeats for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive paclitaxel via infusion on days 1, 8, and 15 or docetaxel IV and carboplatin IV on day 1, and trastuzumab IV and pertuzumab IV on day 1. The chemo and trastuzumab and pertuzumab will most likely be given by the patient's own oncologist per standard of care. Treatment repeats for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ultrasound imaging or magnetic resonance imaging and biopsy on study and blood sample collection throughout the study. Receives: Biological: pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine; Drug: Paclitaxel; Biological: Trastuzumab; Biological: Pertuzumab; Drug: Docetaxel; Drug: Carboplatin; Procedure: Ultrasound Imaging; Procedure: Biopsy Procedure; Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enumeration of the number of T-bet+, CD4+, and CD8+ T-cells in tumor infiltrating lymphocytes (TIL) after combination immune-chemotherapy
Tumor tissue will be collected from prior diagnostic tumor biopsies as well as from an ultrasound guided core needle biopsy performed on day 13 of cycle 3. Tumor biopsies collected pre- and post- trial therapy will be processed and evaluated by immunohistochemistry for differences and changes in T cell content and T cell subtype. Specifically, will evaluate the differences in the presence of T-bet+ CD4+ and CD8+ T cells, a T cell subtype recently recognized to influence both the induced human epidermal growth factor receptor 2 (HER2)-specific cellular immunity and clinical outcomes. Changes in the tumor content of T-bet+ CD4+ and CD8+ T cells between the pre- and post-trial therapy time points will be evaluated.
Measured: Up to completion of surgical resection
Secondary outcomes (2)
Incidence of adverse events
Safety will be assessed per Common Terminology Criteria for Adverse Events version (v)4.0. The type and grade of toxicities noted during the immunization regimen will be summarized. The duration of toxicities will also be summarized using descriptive statistics such as mean and standard deviation. All adverse events noted by the investigator will be tabulated according to the affected body system. The frequency and severity of adverse events will be summarized with a proportion and a 95% confidence interval.
Measured: Up to 5 years
Induction of type 1 helper cell (Th1) immunity against HER2, IGF-1R, and IGFBP2
Cellular immune response will be defined by the magnitude of the Th1 (interferon-gamma [IFN-g]) versus (vs.) type 2 helper cell (Th2) (IL-10) antigen specific immune response using enzyme-linked immunosorbent spot assay (ELISPOT). Immune responses as measured by IFN-g ELISPOT will be summarized with mean and standard deviation or median and range over time, the change over time will be summarized with graphs, and also analyzed using linear mixed-effects regression models with normalizing transformation if necessary. The proportion of study participants who develop immunity to either of the three antigens will be computed and 95% confidence internal would be generated. The induction of Th1 immunity will be compared against the presence or absence of a complete pathologic response to determine if there is a significant correlation using Pearson r correlation analysis.
Measured: Up to day 13 of cycle 4 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start20 Apr 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- William Gwin, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329065
- Sponsor's protocol ID
- RG1005296
- Other IDs
- NCI-2020-01662, W81XWH-16-1-0385, 10159
- Status last verified
- May 2026
- First submitted
- 30 Mar 2020
- Last updated
- 19 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 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Concurrent WOKVAC Vaccination With Neoadjuvant Chemotherapy and HER2-Targeted Monoclonal Antibody Therapy
- ClinicalTrials.gov ID
- NCT04329065
- Acronym / sponsor ID
- RG1005296
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- Keywords
- Breast
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 1 Apr 2020 (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 phase II trial studies the immunologic response and side effects of using the WOKVAC vaccine in combination with chemotherapy and HER2-targeted monoclonal antibody therapy before surgery in treating patients with breast cancer. Vaccines like WOKVAC are made from tumor-associated antigens which may help the body build an effective immune response to kill tumor cells. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are forms of targeted therapy because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab and pertuzumab attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving the WOKVAC vaccine at the same time (concurrently) with paclitaxel, trastuzumab, and pertuzumab before surgery may kill more tumor cells.
Detailed description
OUTLINE:
Patients receive WOKVAC intradermally (ID) on day 13. Treatment repeats for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive paclitaxel via infusion on days 1, 8, and 15 or docetaxel intravenously (IV) and carboplatin IV on day 1, and trastuzumab IV and pertuzumab IV on day 1. The chemo and trastuzumab and pertuzumab will most likely be given by the patient's own oncologist per standard of care. Treatment repeats for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ultrasound imaging or magnetic resonance imaging and biopsy on study and blood sample collection throughout the study.
After completion of study treatment, patients are followed up annually for up to 5 years from enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (WOKVAC, paclitaxel, trastuzumab, pertuzumab) | Experimental | Biological: pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine, Drug: Paclitaxel, Biological: Trastuzumab, Biological: Pertuzumab, Drug: Docetaxel, Drug: Carboplatin, Procedure: Ultrasound Imaging, Procedure: Biopsy Procedure, Procedure: Biospecimen CollectionPatients receive WOKVAC ID on day 13. Treatment repeats for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive paclitaxel via infusion on days 1, 8, and 15 or docetaxel IV and carboplatin IV on day 1, and trastuzumab IV and pertuzumab IV on day 1. The chemo and trastuzumab and pertuzumab will most likely be given by the patient's own oncologist per standard of care. Treatment repeats for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ultrasound imaging or magnetic resonance imaging and biopsy on study and blood sample collection throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must be at least >= 18 years of age
- Clinical stage I-III breast cancer, HER2+ (per American Society of Clinical Oncology [ASCO]/College of American Pathologists [CAP] guideline update, 2018), regardless of estrogen receptor (ER)/ progesterone receptor (PR) status and planning to undergo neoadjuvant therapy with either paclitaxel, trastuzumab, and pertuzumab (THP) or docetaxel, carboplatin, trastuzumab, and pertuzumab (TCHP)
- Patients who have received prior neoadjuvant chemotherapy are allowed but may only receive paclitaxel, trastuzumab, and pertuzumab for the duration the study
- Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- White blood cell (WBC) >= 3000/mm^3 (within 4 weeks of initiating study treatment)
Key exclusion criteria (17 listed)
- Patients with any of the following cardiac conditions:
- Uncontrolled autoimmune disease requiring active systemic treatment
- Known hypersensitivity reaction to the granulocyte-macrophage colony stimulating factor (GM-CSF) adjuvant; any known contra-indication to GM-CSF
- Pregnant or breast feeding
- Known human immunodeficiency virus (HIV)-positive
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 |
|---|---|---|
| pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA VaccineAlso: pUMVC3-IGFBP2-HER2-IGF1R, pUMVC3-IGFBP2-HER2-IGF1R Vaccine, WOKVAC, WOKVAC VaccineGiven ID | Biological | Treatment (WOKVAC, paclitaxel, trastuzumab, pertuzumab) |
| PaclitaxelAlso: Anzatax, Asotax, Bristaxol, PraxelGiven via infusion | Drug | Treatment (WOKVAC, paclitaxel, trastuzumab, pertuzumab) |
| TrastuzumabAlso: Anti-c-erbB2 Monoclonal Antibody, Anti-ERB-2, Anti-erbB2 Monoclonal Antibody, Anti-HER2/c-erbB2 Monoclonal AntibodyGiven IV | Biological | Treatment (WOKVAC, paclitaxel, trastuzumab, pertuzumab) |
| PertuzumabAlso: 2C4 Antibody, Immunoglobulin G1, Anti-(Human V (Receptor)) (Human-Mouse Monoclonal 2C4 Heavy Chain), Disulfide with Human-Mouse Monoclonal 2C4 Kappa-ChainGiven IV | Biological | Treatment (WOKVAC, paclitaxel, trastuzumab, pertuzumab) |
| DocetaxelAlso: RP-56976, RP56976, Taxotere, Taxotere Injection ConcentrateGiven IV | Drug | Treatment (WOKVAC, paclitaxel, trastuzumab, pertuzumab) |
| CarboplatinAlso: Paraplatin, Platinwas, RibocarboGiven IV | Drug | Treatment (WOKVAC, paclitaxel, trastuzumab, pertuzumab) |
| Ultrasound ImagingAlso: USUndergo ultrasound imaging | Procedure or surgery | Treatment (WOKVAC, paclitaxel, trastuzumab, pertuzumab) |
| Biopsy ProcedureAlso: BxUndergo biopsy | Procedure or surgery | Treatment (WOKVAC, paclitaxel, trastuzumab, pertuzumab) |
| Biospecimen CollectionAlso: Biological Sample CollectionUndergo blood sample collection | Procedure or surgery | Treatment (WOKVAC, paclitaxel, trastuzumab, pertuzumab) |
Primary outcome
Enumeration of the number of T-bet+, CD4+, and CD8+ T-cells in tumor infiltrating lymphocytes (TIL) after combination immune-chemotherapy
Time frame: Up to completion of surgical resection
Tumor tissue will be collected from prior diagnostic tumor biopsies as well as from an ultrasound guided core needle biopsy performed on day 13 of cycle 3. Tumor biopsies collected pre- and post- trial therapy will be processed and evaluated by immunohistochemistry for differences and changes in T cell content and T cell subtype. Specifically, will evaluate the differences in the presence of T-bet+ CD4+ and CD8+ T cells, a T cell subtype recently recognized to influence both the induced human epidermal growth factor receptor 2 (HER2)-specific cellular immunity and clinical outcomes. Changes in the tumor content of T-bet+ CD4+ and CD8+ T cells between the pre- and post-trial therapy time points will be evaluated.
2 secondary outcomes
Incidence of adverse events
Time frame: Up to 5 years
Induction of type 1 helper cell (Th1) immunity against HER2, IGF-1R, and IGFBP2
Time frame: Up to day 13 of cycle 4 (each cycle is 21 days)
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 19 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.
William Gwin principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine, Paclitaxel and Trastuzumab in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by University of Washington 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 14 inclusion and 17 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 19 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jennifer Childs (206-616-2305, childj@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enumeration of the number of T-bet+, CD4+, and CD8+ T-cells in tumor infiltrating lymphocytes (TIL) after combination immune-chemotherapy (time frame: Up to completion of surgical resection). 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 19 May 2026.