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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06868433
Phase
PHASE1
Status
Recruiting
Apply to this trial

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Autologous Tumor Membrane Vesicles Vaccine — BIOLOGICAL
    Given intradermally
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Echocardiography — PROCEDURE
    Undergo echocardiography
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET
  • Surgical Procedure — PROCEDURE
    Provide tissue from standard of care surgery

Study Details

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.

Key Dates

Start date
May 8, 2025
Status verified
Mar 2026
Primary completion
Jan 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 (TMV vaccine therapy)
    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 CT, MRI or PET on study.
  • Experimental: Cohort 2 (TMV vaccine therapy, pembrolizumab)
    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 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.

Primary Outcome Measure

Dose-limiting toxicity (DLT) [ Time Frame: From first dose of treatment up to 7 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Emory University Hospital MidtownAtlantaGeorgia30308
Nilaab Meer
[email protected]
404-686-1794
Nabil F. Saba, M.D.
[email protected]
404-778-1900
Dong M. Shin, MD, FACP, FAAAS (PRINCIPAL_INVESTIGATOR)
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322
Nilaab Meer
[email protected]
404-686-1794
Dong M. Shin, MD, FACP, FAAAS (PRINCIPAL_INVESTIGATOR)

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