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Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Phase 1NCT06868433

TMV Vaccine Therapy Alone and With Pembrolizumab for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer

A Phase 1 study testing Autologous Tumor Membrane Vesicles Vaccine, Biospecimen Collection and Computed Tomography in people with Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Metastatic Head and Neck Squamous Cell Carcinoma, run by Emory University at 2 sites 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
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Trial summary

This phase Ib trial tests the safety, side effects and best dose of tumor membrane vesicle (TMV) vaccine therapy alone and in combination with pembrolizumab and evaluates how well it works in treating patients with head and neck squamous cell cancer that has come back after a period of improvement (recurrent) or that… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Autologous Tumor Membrane Vesicles Vaccine, Biospecimen Collection and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesUnited States
Study dates
8 May 2025to 31 Dec 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

  • Must be at least ≥ 18 years of age
  • Histologically proven squamous cell carcinoma of the head and neck (HNSCC), amenable to salvage surgery. p16 positive and negative allowed. Squamous cell carcinoma of the oral cavity, larynx, hypopharynx, oropharynx, nasopharynx, sinonasal carcinoma and cancer of unknown primary (squamous cell carcinoma only) are all allowed. They will be allowed to have up to 3 different regimens after diagnosed of recurrent or metastatic HNSCC
  • Oropharyngeal tumors must have p16 or human papillomavirus (HPV) testing done
  • The tumor tissues must be available and banked (- 80°C) at the time of salvage surgery (1st informed consent form [ICF] must be signed)
  • Recurrent and/or metastatic HNSCC that has failed standard chemotherapy and immunotherapy. Eligible subjects must have progressed on ≥ 2 lines of standard of care prior to starting trial therapy. For patients who have relapsed within 6 months of systemic therapy given with curative intent, that therapy will count as a line of metastatic therapy. Eligible subjects will have no restriction on prior lines of therapy in the metastatic/advanced disease setting
  • The tumors should be measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
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  • Must have enough tissue collected after salvage surgery to make at least 3 doses of vaccine (minimum weight of the resectable tumor tissue is ≥ .5 grams) and adequate cellularity (> 40% cellularity) assessed by the head and neck pathologists
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  • Absolute neutrophil count ≥ 1,500 cells/uL
  • Platelets ≥ 100,000/uL
  • Hemoglobin ≥ 9.0g/dL (may receive packed red blood cell [prbc] transfusion)
  • Total bilirubin ≤ 1.5 x the upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
  • Albumin ≥ 3.0 g/dL
  • Serum creatinine ≤ 1.5 x ULN
  • Calculated creatinine clearance of ≥ 50 mL/min
  • International normalized ratio (INR) ≤ 1.5. Anticoagulation is allowed only with low molecular weight heparin (LMWH). Patient receiving low molecular weight (LMW) heparin on stable therapeutic dose for more than 2 weeks or with factor Xa level < 1.1U/mL are allowed on the trial
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
  • Ability to understand and willingness to sign written informed consent documents
  • Female subjects of childbearing potential must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment and 3 months after completion
  • Male subjects must agree to use adequate contraception (e.g., condoms; abstinence) for the duration of study treatment and 3 months after completion
  • Female subjects of childbearing age must have a negative serum pregnancy test at study entry
  • Patients who have received prior pembrolizumab are eligible

Who cannot join

  • Salivary tumors and non-squamous cell histology in head and neck cancer
  • Not enough tissue collected after surgery for a planned 3 doses (weight of the resectable tumor tissue is less than 1.0 gram)
  • Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation)
  • Prior organ allograft or allogeneic bone marrow transplantation
  • Subjects with any active autoimmune disease or history of known or suspected autoimmune disease except for subjects with vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
  • Subjects with a condition requiring systemic treatment with either corticosteroids (> 10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
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  • Women who are pregnant or lactating, and child-bearing potential women without adequate contraception
  • Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study
  • Clinical evidence of bleeding diathesis or coagulopathy
  • Patients with prior malignancies, including pelvic cancer, are eligible if they have been disease free for > 5 years. Patients with prior in situ carcinomas are eligible provided there was complete removal
  • Active bacterial or fungal infections requiring systemic treatment within 7 days of treatment
  • Use of other investigational drugs (drugs not marked for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration
  • History of severe hypersensitivity reactions to other monoclonal antibodies
  • Non-oncology vaccines within 28 days prior to planned treatment

Trial locations and contacts

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

Dong M. Shin, MD, FACP, FAAAS contact

404-778-2980

dmshin@emory.edu

United States2 sites, 2 recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Nilaab Meer, 404-686-1794, nilaab.meer@emory.edu

    Nabil F. Saba, M.D., 404-778-1900, NFSABA@emory.edu

    Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Nilaab Meer, 404-686-1794, madison.miller.stallings@emory.edu

    Dong M. Shin, MD, FACP, FAAAS

    Recruiting

Other trials in United States

About this study

Official title: Phase 1b Study of TMV Vaccine Therapy Alone and TMV Vaccine Plus Pembrolizumab for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

This phase Ib trial tests the safety, side effects and best dose of tumor membrane vesicle (TMV) vaccine therapy alone and in combination with pembrolizumab and evaluates how well it works in treating patients with head and neck squamous cell cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Vaccines made from a person's tumor cells, such as TMV vaccines, may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving TMV vaccine therapy alone or with pembrolizumab may be safe, tolerable and/or effective in treating patients with recurrent and/or metastatic head and neck squamous cell cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the safety, tolerability, and recommended dose and schedule of TMV vaccine alone or TMV vaccine plus pembrolizumab in patients with surgically resected, recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC).

SECONDARY OBJECTIVE:

  1. To assess vaccine-induce immune activity, antitumor response, progression-free survival (PFS) and overall survival (OS) in adult patients with recurrent and/or metastatic HNSCC administered TMV vaccine alone and TMV vaccine plus pembrolizumab.

TERTIARY/EXPLORATORY OBJECTIVES:

  1. Determine whether TMV vaccine induces immune response and the magnitude of the response.

II. Next-generation sequencing (NGS) will be performed using patients' tumor samples and peripheral blood mononuclear cells to assess tumor mutational burden and identify potential neoantigens.

OUTLINE: This is a dose-escalation study of TMV vaccine alone and in combination with (fixed-dose) pembrolizumab. Patients are assigned to 1 of 2 cohorts.

COHORT 1: Patients provide tissue from standard of care surgery to generate vaccine. The tumor tissue will be banked. When the patient's cancer recurs or metastasis occurs the patient will be treated as indicated. If the cancer progresses, TMV vaccine will be formulated using the banked tumor tissue. Patients receive TMV vaccine intradermally once every 2 weeks for up to 3 doses. Patients undergo echocardiography at baseline and at end of treatment and blood sample collection throughout the study. Patients may also undergo additional computed tomography (CT), magnetic resonance imaging (MRI) or positron emission tomography (PET) on study.

COHORT 2: Patients provide tissue from standard of care surgery to generate vaccine. The tumor tissue will be banked. When the patient's cancer recurs or metastasis occurs the patient will be treated as indicated. If the cancer progresses, TMV vaccine will be formulated using the banked tumor tissue. Patients receive TMV vaccine intradermally once every 2 weeks for up to 3 doses. Patients also receive pembrolizumab intravenously (IV) on day 1 of each cycle. Cycles repeat every 3 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography at baseline and at end of treatment and blood sample collection throughout the study. Patients may also undergo additional CT, MRI or PET on study.

After completion of study treatment, patients are followed up on day 90 then every 3 weeks for up to 12 months.

Being tested
Autologous Tumor Membrane Vesicles Vaccine, Biospecimen Collection, Computed Tomography, Echocardiography, Magnetic Resonance Imaging
Keywords
Recurrent or metastatic head and neck cancer whose tumor should have banked at the time of surgery.
Medical subject headings
Oropharyngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck, Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Mouth Neoplasms, Nasopharyngeal Carcinoma, Carcinoma, Recurrence

What participants receive

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

  • Autologous Tumor Membrane Vesicles VaccineBiological

    Also called Autologous TDMV-derived Vaccine, Autologous TMV Vaccine, Autologous TMV-based Vaccine, Autologous Tumor-derived Membrane Vesicles Vaccine

    Given intradermally

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • EchocardiographyProcedure or surgery

    Also called EC

    Undergo echocardiography

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • PembrolizumabBiological

    Also called BCD-201, GME 751, GME751, Keytruda

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET

  • Surgical ProcedureProcedure or surgery

    Also called Operation, Surgery, Surgery Type, Surgery, NOS

    Provide tissue from standard of care surgery

Study groups in NCT06868433
Study groupRoleWhat they receive
Cohort 1 (TMV vaccine therapy)ExperimentalPatients provide tissue from standard of care surgery to generate vaccine. The tumor tissue will be banked. When the patient's cancer recurs or metastasis occurs the patient will be treated as indicated. If the cancer progresses, TMV vaccine will be formulated using the banked tumor tissue. Patients receive TMV vaccine intradermally once every 2 weeks for up to 3 doses. Patients undergo echocardiography at baseline and at end of treatment and blood sample collection throughout the study. Patients may also undergo additional CT, MRI or PET on study.
Receives: Biological: Autologous Tumor Membrane Vesicles Vaccine; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Echocardiography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Procedure: Surgical Procedure
Cohort 2 (TMV vaccine therapy, pembrolizumab)ExperimentalPatients provide tissue from standard of care surgery to generate vaccine. The tumor tissue will be banked. When the patient's cancer recurs or metastasis occurs the patient will be treated as indicated. If the cancer progresses, TMV vaccine will be formulated using the banked tumor tissue. Patients receive TMV vaccine intradermally once every 2 weeks for up to 3 doses. Patients also receive pembrolizumab IV on day 1 of each cycle. Cycles repeat every 3 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography at baseline and at end of treatment and blood sample collection throughout the study. Patients may also undergo additional CT, MRI or PET on study.
Receives: Biological: Autologous Tumor Membrane Vesicles Vaccine; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Echocardiography; Procedure: Magnetic Resonance Imaging; Biological: Pembrolizumab; Procedure: Positron Emission Tomography; Procedure: Surgical Procedure

What is being measured

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

  1. Dose-limiting toxicity (DLT)

    DLT will be defined as treatment-related adverse event that is hematologic grade 4 or non-hematologic of grade 3 or higher severity using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. DLTs will be summarized as frequency and percentage by dose levels for cohort 1 and 2 separately.

    Measured: From first dose of treatment up to 7 weeks

  2. Incidence of treatment-emergent adverse events (TEAE)

    Adverse events will be assessed and graded according to NCI CTCAE v 5.0. TEAEs will be summarized based on the number (percentage) of patients experiencing events. Summaries of treatment-related TEAEs, grade 3 or higher TEAEs, serious TEAEs, and TEAEs leading to discontinuation of study drug will be provided. TEAEs and the treatment-related TEAEs will also be summarized by severity.

    Measured: Up to 30 days after last dose of treatment

  3. Recommended phase 2 dose (RP2D)

    Will be determined by the principal investigator based upon all available safety and immune response data by dose levels from both cohorts 1 and 2. The RP2D may not exceed the maximum tolerated dose as estimated in cohort 2.

    Measured: Up to 7 weeks

Secondary outcomes (4)

  1. Vaccine-induced immune response

    Response will be defined as the fold-change of IFNg+CD4/CD8 T cells by fluorescence activated cell sorting from peripheral blood before and after each vaccination. Summary statistics (mean, median, quartile [Q]1-Q3) will be used to describe it by dose level and time points.

    Measured: Before and after each vaccination up to 6 weeks

  2. Tumor response rate

    Will be assessed using Response Evaluation Criteria in Solid Tumors 1.1 criteria. Tumor response will be summarized descriptively using frequencies and percentages. Response rate will be calculated as proportion along with 95% confidence intervals using the Clopper-Pearson method.

    Measured: Up to 12 months

  3. Progression-free survival (PFS)

    PFS rates will be estimated with the Kaplan-Meier method and compared between different groups using the log-rank test.

    Measured: From start of treatment to time of progression or death up to 12 months

  4. Overall survival (OS)

    OS rates will be estimated with the Kaplan-Meier method and compared between different groups using the log-rank test.

    Measured: From start of treatment to time of death up to 12 months

Timeline

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

  1. First posted11 Mar 2025
  2. Study start8 May 2025
  3. Primary completion31 Jan 2028 (estimated)
  4. Study completion31 Dec 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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06868433
Sponsor's protocol ID
STUDY00006705
Other IDs
NCI-2024-08422, STUDY00006705, Winship6045-23, P30CA138292, 1R01CA262123-01A1
Status last verified
Mar 2026
First submitted
5 Mar 2025
Last updated
4 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Autologous Tumor Membrane Vesicles Vaccine, Biospecimen Collection and Computed Tomography in people with Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Metastatic Head and Neck Squamous Cell Carcinoma, run by Emory University at 2 sites 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 23 inclusion and 15 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 4 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 2 sites 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 Dong M. Shin, MD, FACP, FAAAS (404-778-2980, dmshin@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) (time frame: From first dose of treatment up to 7 weeks). 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?

On the ClinicalTrials.gov record for NCT06868433.

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 4 Mar 2026.

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