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AzTrials

Anatomic Stage IV Breast Cancer AJCC v8Phase 1NCT05098210

Personalized Neo-Antigen Peptide Vaccine for the Treatment of Stage IIIC-IV Melanoma, Hormone Receptor Positive HER2 Negative Metastatic Refractory Breast Cancer or Stage III-IV Non-Small Cell Lung Cancer

A Phase 1 study testing Neoantigen Peptide Vaccine, Nivolumab and Poly ICLC in people with Anatomic Stage IV Breast Cancer AJCC v8 and Clinical Stage IV Cutaneous Melanoma AJCC v8, run by Fred Hutchinson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This phase I trial studies the safety of personalized neo-antigen peptide vaccine in treating patients with stage IIIC-IV melanoma, hormone receptor positive HER2 negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or does not respond to treatment… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Neoantigen Peptide Vaccine, Nivolumab and Poly ICLC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteUnited States
Study dates
9 Jun 2022to 1 Nov 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

  • Female and/or male patients age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
  • Patients must have at least 1 lesion (or aggregate lesions) to obtain tumor tissue for resection of >= 1 cm or >= 4 core biopsies acceptable. Amenable to image (CT, ultrasound [U/S], or magnetic resonance imaging [MRI]) guided biopsy for tissue collection necessary for neoantigen identification. Either primary or metastatic sites are options for tissue collection
  • Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria: Participants must have measurable disease, defined as at least one target lesion that can be measured in at least one dimension (longest diameter to be recorded) as >= 10 mm, unless lymph node in which case short axis must be >= 15 mm. Baseline imaging (for example diagnostic CT chest/abdomen/pelvis, PET CT scan and imaging of the affected extremity as appropriate), brain imaging (MRI or CT scan) must be obtained within 45 days of prior to start of first planned vaccine dose infusion. MRI can be substituted for CT in patients unable to have CT contrast
  • Serum creatine < 1.5 mg/dL or estimated glomerular filtration rate (eGFR) > 60 mL/min
  • Total bilirubin (tBili) < 1.5 x upper limit of normal (ULN) and an aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 x ULN and < 5 x ULN for subjects with documented liver metastasis. Patients with suspected Gilbert syndrome may be included if tBili > 3 but no other evidence of hepatic dysfunction
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  • =< grade 1 dyspnea and arterial oxygen saturation (SaO2) >= 92% on ambient air. If pulmonary function tests (PFTs) are performed based on the clinical judgement of the treating physician, patients with forced expiratory volume in 1 second (FEVI) >= 70% of predicted and carbon monoxide diffusing capability (DLCO) (corrected) of >= 60% of predicted will be eligible
  • Patients with active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis requiring treatment with systemic steroids will be excluded
  • Patients 60 years of age or older are required to have left ventricular ejection fraction (LVEF) evaluation performed within 60 days prior to enrollment. LVEF may be established with echocardiogram or MUGA scan, and left ejection fraction must be >= 50%. Cardiac evaluation for other patients is at the discretion of the treating physician
  • Subjects with a history of myocarditis or congestive heart failure (as defined by New York Heart Association functional classification III or IV), as well as unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction 6 months prior to study entry will be excluded
  • Absolute neutrophil count (ANC) > 1000 cells/mm^3
  • Hemoglobin >= 9 mg/dL
  • Platelet count >= 50,000/uL
  • Toxicity from prior therapy must be recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.)5 grade 2 or less
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures
  • Capable of understanding and providing a written informed consent
  • The effects of neoantigen vaccination on the developing human fetus are unknown. For this reason, patients who are having sex that can lead to pregnancy must agree to use adequate contraception (hormonal, barrier method of birth control, or abstinence) for the duration of study participation. Should a woman become pregnant while participating in the study, she should inform her study doctor immediately and will not receive any more study treatment
  • MELANOMA SPECIFIC: Tissue confirmation of melanoma: Histologically confirmed metastatic (recurrent or de novo stage IV) or unresectable locally advanced (stage IIIC or IIID) cutaneous, acral, conjunctival or mucosal melanoma, as defined by the American Joint Committee on Cancer (AJCC) v8.0. Confirmation of diagnosis must be or have been performed by internal pathology review of archival, initial or subsequent biopsy or other pathologic material at Fred Hutchinson Cancer Center (FHCC)/University of Washington Medical Center (UWMC)
  • MELANOMA SPECIFIC: Patients must have received stage specific standard of care therapy per National Comprehensive Cancer Network (NCCN) guidelines and have persistent/recurrent disease after at least one line of therapy prior to enrollment on the study
  • MELANOMA SPECIFIC: Known BRAF mutational status
  • MELANOMA SPECIFIC: History of detectable disease during/after treatment with a PD-1 or PD-L1 inhibitor, as defined by the Society of Immunotherapy of Cancer's definition of primary or secondary resistance (Kluger and others [et al.], 2020):
  • Drug exposure >= 6 weeks and best response progressive disease (PD) or stable disease (SD) < 6 months or
  • Drug exposure >= 6 months and best response complete response (CR), partial response (PR), or SD > 6 months
  • MELANOMA SPECIFIC: A confirmatory scan performed at least 4 weeks after disease persistence/progression is required but this requirement can be waived if the judgement of the treating clinician is that the patient would be at risk of rapid or symptomatic progression in that interval. This confirmatory scan can occur during production of the vaccine after enrollment
  • BREAST CANCER SPECIFIC: Tissue confirmation of stage IV (recurrent or de novo metastatic) hormone receptor (HR) positive, HER2 negative breast cancer:
  • Hormone receptor (HR) positive breast cancer as defined by either one, or both of the following criteria:
  • Estrogen receptor (ER) positive disease defined as follows documented by a local laboratory: 1-100% positive stained cells based on de novo tumor biopsy
  • Progesterone receptor (PR) positive disease defined as follows documented by a local laboratory: 1-100% positive stained cells based on de novo tumor biopsy
  • Human epidermal growth factor receptor 2 (HER2) negative breast cancer (per American Society of Clinical Oncology [ASCO]/College of American Pathologists [CAP] guideline update, 2018) as documented by a local laboratory with HER2-negativity defined as:
  • Immunohistochemistry score 0/1+ or 2+ and / or
  • Negative by in situ hybridization (fluorescence in situ hybridization [FISH]/chromogenic in situ hybridization [CISH]/silver-enhanced in situ hybridization [SISH]) per ASCO/CAP guideline update, 2018
  • Confirmation of diagnosis must be or have been performed by internal pathology review of archival, initial or subsequent biopsy or other pathologic material at FHCC/UWMC
  • BREAST CANCER SPECIFIC: Patients must have received at least one line of systemic therapy in the metastatic setting prior to enrollment on the study and have progressive/persistent disease after
  • NON-SMALL CELL LUNG CANCER SPECIFIC: Tissue confirmation of stage III unresectable or stage IV (recurrent or de novo metastatic) non-small cell lung cancer (NSCLC):
  • Genetic testing must have been performed for targetable driver mutations, including EGFR, ROS1, Alk, KRAS, BRAF
  • Confirmation of diagnosis must be or have been performed by internal pathology review of archival, initial or subsequent biopsy or other pathologic material at FHCC/UWMC
  • NON-SMALL CELL LUNG CANCER SPECIFIC: Patients must have received at least one line of systemic therapy in the metastatic or stage II or III setting including a PD-1 or PD-L1 inhibitor prior to enrollment on the study and have progressive or recurrent disease after
  • NON-SMALL CELL LUNG CANCER SPECIFIC: For patients who have received neoadjuvant, adjuvant, and/or consolidation anti-PD-1 or anti-PD-L1 for stage II or III disease, they must have experienced disease progression in less than or equal to 365 days from initiation (cycle 1 day 1) of anti-PD-1 or anti-PD-L1 therapy for this to count as the systemic therapy for advanced disease. Patients experiencing progression more than 365 days from initiation (cycle 1 day 1) of anti-PD-1 or anti-PD-L1 therapy will not be considered as having received one line of systemic therapy. These patients must have received an anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease

Who cannot join

  • Fertile male patients and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 5 months after the last dose of investigational product
  • Any history of an immune-related grade 4 adverse event attributed to prior cancer immunotherapy CIT (other than endocrinopathy managed with replacement therapy or asymptomatic elevation of serum amylase or lipase)
  • Any history of an immune-related grade 3 adverse event attributed to prior CIT that required permanent discontinuation of PD-1 inhibitor therapy
  • Immune-related adverse events related to prior CIT (other than endocrinopathy managed with replacement therapy or stable vitiligo) that have not resolved to baseline. Patients treated with corticosteroids for immune-related adverse events must demonstrate absence of related symptoms or signs for >= 4 weeks following discontinuation of corticosteroids
  • Uncontrolled tumor-related pain. Patients requiring narcotic pain medication must be on a stable regimen at study entry. Symptomatic lesions amenable to palliative radiotherapy (e.g., bone metastases or metastases causing nerve impingement) should be treated > 4 weeks prior to enrollment. Patients should be recovered from the effects of radiation
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage more than once every 28 days. Indwelling drainage catheters (e.g., PleurX®) are allowed
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  • Patients with known symptomatic brain metastases. Patients with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stable for >= 1 months (confirmed by magnetic resonance imaging [MRI])
  • Patients with rapidly progressing disease, symptomatic visceral disease, or patients who are expected to have rapidly progressive disease over the course of several months despite bridging therapy approved by the protocol
  • Known primary immunodeficiencies, either cellular (e.g., DiGeorge syndrome, T-negative severe combined immunodeficiency [SCID]) or combined T- and B-cell immunodeficiencies (e.g., T- and B-negative SCID, Wiskott-Aldrich syndrome, ataxia telangiectasia, common variable immunodeficiency)
  • Prior allogeneic bone marrow transplantation or prior solid organ transplantation
  • Known positive test for HIV infection
  • Patients with active infection causing fever (temperature > 38.1 degrees Celsius [C]) or subjects with unexplained fever (temperature > 38.1 degrees C) may not receive the investigational product unless the fever is =< 38.1 for 5 days prior to start
  • Active uncontrolled infection: individuals with a history of hepatitis C who have successfully completed antiviral therapy with an undetectable viral load, and those with hepatitis B who have, per standard practice, hepatitis well-controlled on medication (e.g., AST and ALT < 5 x ULN) can be included
  • History of autoimmune disease that has not been controlled with treatment in the last 12 months, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis with the following exceptions: Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible. Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., no psoriatic arthritis) may be eligible
  • Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone > 10 mg/day or equivalent, cyclophosphamide, azathioprine, methotrexate, thalidomide, and TNF-alpha antagonists) within 2 weeks prior screening. The use of topical, eye drops, local injections, or inhaled corticosteroids (e.g. fluticasone for chronic obstructive pulmonary disease) is allowed. The use of oral mineralocorticoids (e.g. fludrocortisone for patients with orthostatic hypotension) is allowed. Physiologic doses of corticosteroids for adrenal insufficiency are allowed. Low dose corticosteroids for a short duration [5 mg once daily (QD) prednisone for 2 weeks] as symptomatic treatment and upon with discussion with the investigator is allowed. Note: Patients with adrenal insufficiency may take 10 mg of prednisone or equivalent daily
  • Subjects should have an international normalized ratio (INR) or activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy should have a prothrombin time (PT) or partial thromboplastin time (PTT) within therapeutic range of intended use and no history of severe hemorrhage. Antiplatelet agents (eg, aspirin, clopidogrel, etc.) are not considered anticoagulants for the purposes of this study (i.e., they are allowed)
  • Other medical, social, or psychiatric factor that interferes with medical appropriateness and/or ability to comply with study, as determined by the principal investigator (PI)
  • Participants of childbearing potential must have a negative serum pregnancy test within 14 days prior to enrollment. Childbearing potential is defined as women who have not been surgically sterilized and who are not post-menopausal (free of menses for at least 1 year)
  • Female patients who are lactating or intend to breastfeed during the duration of the study
  • Patients who have received a live vaccine within 30 days prior to enrollment
  • Patients with any underlying medical condition for which, in the investigator's opinion, participation would not be in the best interest of the participant (e.g.- compromises the health of the subject) or that could prevent, limit or confound protocol assessments
  • MELANOMA SPECIFIC: Uveal or choroidal melanoma. This entity is excluded due to the absence of abundant mutations
  • BREAST SPECIFIC: Patients with symptomatic disease including patients with symptomatic lung metastases, bone marrow replacement with associated cytopenia, or significant liver metastases with associated liver dysfunction
  • NON-SMALL CELL LUNG CANCER SPECIFIC: Activating mutations in EGFR or genetic alterations in ROS1 or Alk, as these mutations are associated with lower mutation burden and non-response to immune therapies

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

FHCC Intake contact

206-606-1024

hutchdoc@fredhutch.org

United States1 site, 1 recruiting

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

    FHCC Intake, 206-606-1024, hutchdoc@fredhutch.org

    Joshua Veatch

    Recruiting

Other trials in United States

About this study

Official title: PNV21-001: A Phase I Study of a Personalized Multi-Peptide Neo-Antigen Vaccine in Breast Cancer, Pre-Treated Nonsmall Cell Lung Cancer and PD1/PD-L1 Inhibitor-Refractory Melanoma

This phase I trial studies the safety of personalized neo-antigen peptide vaccine in treating patients with stage IIIC-IV melanoma, hormone receptor positive HER2 negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or does not respond to treatment (refractory) or stage III-IV non-small cell lung cancer. Personalized neo-antigen peptide vaccine is a product that combines multiple patient specific neo-antigens. Given personalized neo-antigen peptide vaccine together with Th1 polarizing adjuvant poly ICLC may induce a polyclonal, poly-epitope, cytolytic T cell immunity against the patient's tumor.

Read the detailed description

OUTLINE:

Patients receive poly ICLC intramuscularly (IM) or intratumorally (IT) once weekly in weeks when no vaccine is given. Beginning 2 weeks after starting poly ICLC, patients receive personalized neo-antigen peptide vaccine IM once every 4 weeks and nivolumab intravenously (IV) every 2 or 4 weeks. Treatment continues for 25 weeks in the absence of disease progression or unacceptable toxicity. Patients determined to have clinical benefit on a first course of treatment may repeat a 6-month course of treatment as described above. Patients then receive nivolumab IV every 2 or 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity. Upon radiographic disease progression or completion of treatment with stable disease, patients may be offered ruxolitinib 20 mg orally twice daily for one month while continuing PD-1 inhibitor therapy. Ruxolitinib may be extended beyond one month if the treating physician believes continued treatment is of clinical benefit. Additionally, patients may undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening. Patients also undergo tumor biopsy, blood sample collection, and computed tomography (CT) and/or positron emission tomography (PET) throughout the study.

After completion of study treatment, patients are followed up at 24, 36, and 48 weeks. Patients who do not have disease progression and continue nivolumab monotherapy or off treatment will continue post-treatment follow up for an additional 12 months.

Being tested
Neoantigen Peptide Vaccine, Nivolumab, Poly ICLC, Echocardiography Test, Multigated Acquisition Scan
Medical subject headings
Melanoma, Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neoantigen Peptide VaccineBiological

    Given IM

  • NivolumabBiological

    Also called BMS-936558, CMAB819, MDX-1106, NIVO

    Given IV

  • Poly ICLCDrug

    Also called Hiltonol, Poly I:Poly C with Poly-L-Lysine Stabilizer, poly-ICLC, PolyI:PolyC with Poly-L-Lysine Stabilizer

    Given IM or IT

  • Echocardiography TestProcedure or surgery

    Also called EC

    Undergo ECHO

  • Multigated Acquisition ScanProcedure or surgery

    Also called MUGA Scan

    Undergo MUGA

  • Biopsy ProcedureProcedure or surgery

    Also called Bx

    Undergo tumor biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT Scan, CT Scan, Computed Axial Tomography

    Undergo CT or PET/CT

  • Positron Emission TomographyProcedure or surgery

    Also called PET scan

    Undergo PET or PET/CT

  • RuxolitinibDrug

    Also called INCB 018424, Oral JAK Inhibitor INCB18424

    Given PO

Study groups in NCT05098210
Study groupRoleWhat they receive
Treatment (poly ICLC, neo-antigen peptide vaccine, nivolumab)ExperimentalPatients receive poly ICLC IM or IT once weekly in weeks when no vaccine is given. Beginning 2 weeks after starting poly ICLC, patients receive personalized neo-antigen peptide vaccine IM once every 4 weeks and nivolumab IV every 2 or 4 weeks. Treatment continues for 25 weeks in the absence of disease progression or unacceptable toxicity. Patients determined to have clinical benefit on a first course of treatment may repeat a 6-month course of treatment as described above. Patients then receive nivolumab IV every 2 or 4 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity. Upon radiographic disease progression or completion of treatment with stable disease, patients may be offered ruxolitinib while continuing PD-1 inhibitor therapy; see Detailed Description for more information. Additionally, patients may undergo ECHO or MUGA during screening. Patients also undergo tumor biopsy, blood sample collection, and CT and/or PET throughout the study.
Receives: Biological: Neoantigen Peptide Vaccine; Biological: Nivolumab; Drug: Poly ICLC; Procedure: Echocardiography Test; Procedure: Multigated Acquisition Scan; Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Drug: Ruxolitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events

    Will be assessed by Common Terminology Criteria for Adverse Events version 5.0.

    Measured: 1 year post first vaccination

Secondary outcomes (6)

  1. Number of formulated and administered personalized neo-antigen vaccines

    Measured: Week 48

  2. Number of formulated personalized neo-antigen vaccines with at least five (5) vaccine peptides

    Measured: Week 48

  3. Number of formulated personalized neo-antigen vaccines in less than 16 weeks since screening visit biopsy

    Measured: 16 weeks

  4. Evaluation of target lesion

    By Response Evaluation Criteria In Solid Tumors (RECIST) and Immune-Modified RECIST criteria.

    Measured: At 1 year post first vaccination

  5. Best overall response

    Will be assessed by immune-related Response Evaluation Criteria in Solid Tumors criteria.

    Measured: 1 year post first vaccination

  6. Progression-free survival

    Will be estimated using the method of Kaplan and Meier.

    Measured: 1 year post first vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2021
  2. Study start9 Jun 2022
  3. Primary completion1 Nov 2027 (estimated)
  4. Study completion1 Nov 2028 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05098210
Sponsor's protocol ID
RG1121642
Other IDs
NCI-2021-10199, 10668
Status last verified
Jul 2026
First submitted
14 Oct 2021
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Neoantigen Peptide Vaccine, Nivolumab and Poly ICLC in people with Anatomic Stage IV Breast Cancer AJCC v8 and Clinical Stage IV Cutaneous Melanoma AJCC v8, run by Fred Hutchinson Cancer Center 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 38 inclusion and 24 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 22 Jul 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 FHCC Intake (206-606-1024, hutchdoc@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: 1 year post first vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05098210.

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 22 Jul 2026.

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