TMV Vaccine + Pembrolizumab for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byDong M. Shin, MD, FACP, FAAAS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Emory University

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for patients with recurrent or metastatic head and neck squamous cell cancer. Participants should have a type of skin, throat, nasal, oral, or laryngeal cancer that has returned after treatment or spread to other body parts.

Inclusion Criteria

Various hematologic and biochemical parameters within specified ranges

Ability to understand and willingness to sign written informed consent documents

Tumors should be measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria

+12 more

Exclusion Criteria

My cancer is a non-squamous cell type in the head or neck, or is a salivary gland tumor.

My surgery did not collect enough tissue for 3 doses.

I am on long-term immunosuppressants or have had an organ or bone marrow transplant.

+5 more

Participant Groups

The trial is testing the safety and optimal dose of TMV vaccine therapy alone and combined with pembrolizumab. It aims to see how well these treatments help the immune system fight off cancer in patients with advanced head and neck cancers.

2Treatment groups

Experimental Treatment

Group I: Cohort 2 (TMV vaccine therapy, pembrolizumab)Experimental Treatment8 Interventions

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.

Group II: Cohort 1 (TMV vaccine therapy)Experimental Treatment7 Interventions

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.