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TMV Vaccine Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Cancer

This study is testing a vaccine made from your own tumor cells, called Autologous Tumor Membrane Vesicles (TMV) vaccine, by itself and with pembrolizumab. Pembrolizumab is an immunotherapy that helps your immune system fight cancer. This study is for people aged 18 and older with head and neck squamous cell cancer that has come back or spread. Researchers want to find out how safe these treatments are, what side effects they might cause, and the best dose to use. They will also look at how well the treatments work to shrink tumors and improve survival. The study is currently unclear on its recruitment status.

Study design
This is a dose-escalation study with 40 planned participants, looking at TMV vaccine alone and in combination with pembrolizumab.
What's involved
You would provide tumor tissue for vaccine creation, undergo blood draws, CT scans, echocardiograms, and MRIs. You would receive the TMV vaccine intradermally (just under the skin) every two weeks for up to three doses.
Compensation
Not stated in the trial record.
Follow-up
The study will measure side effects up to 30 days after your last treatment dose, and will determine the recommended dose up to 7 weeks after the first dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06868433

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Emory University
~40 participants
Updated 2026-03-04 on ClinicalTrials.gov
What's tested:Autologous Tumor Membrane Vesicles VaccineBiospecimen CollectionComputed TomographyEchocardiographyMagnetic Resonance ImagingPembrolizumab

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-limiting toxicity (DLT)
Measured over From first dose of treatment up to 7 weeks
+2 more outcomes measured

Conditions

Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Metastatic Head and Neck Squamous Cell Carcinoma
Metastatic Hypopharyngeal Squamous Cell Carcinoma
Metastatic Laryngeal Squamous Cell Carcinoma
Metastatic Nasopharyngeal Squamous Cell Carcinoma
Metastatic Oral Cavity Squamous Cell Carcinoma
Metastatic Oropharyngeal Squamous Cell Carcinoma
Metastatic Sinonasal Squamous Cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma
Recurrent Hypopharyngeal Squamous Cell Carcinoma
Recurrent Laryngeal Squamous Cell Carcinoma
Recurrent Nasopharyngeal Squamous Cell Carcinoma
Recurrent Oral Cavity Squamous Cell Carcinoma
Recurrent Oropharyngeal Squamous Cell Carcinoma
Recurrent Sinonasal Squamous Cell Carcinoma
Squamous Cell Carcinoma of Unknown Primary
Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
Stage IV Hypopharyngeal Carcinoma AJCC v8
Stage IV Laryngeal Cancer AJCC v8
Stage IV Lip and Oral Cavity Cancer AJCC v8
Stage IV Nasopharyngeal Carcinoma AJCC v8
Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Stage IV Sinonasal Cancer AJCC v8

Explore related trials

Head and Neck Squamous Cell Carcinoma

Where it's being run

2 sites across 1 states
Georgia2

Study leadership

  • Dong M. Shin, MD, FACP, FAAAS · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

Dong M. Shin, MD, FACP, FAAAS
[email protected]
404-778-2980
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

Exclusion

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
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

What this trial measures

  • Dose-limiting toxicity (DLT)From first dose of treatment up to 7 weeks

    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.

  • Incidence of treatment-emergent adverse events (TEAE)Up to 30 days after last dose of treatment

    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.

  • Recommended phase 2 dose (RP2D)Up to 7 weeks

    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.