TMV Vaccine With Pembrolizumab

PRIMARY OBJECTIVE: I. 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: I.

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: I. Determine whether TMV vaccine induces immune response and the magnitude of the response. II.

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.

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.

Registro actualizado en ClinicalTrials.gov →

• 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

Criterios de inclusión tal como figuran en el registro, recortados. La lista completa, con las exclusiones, está en el registro actualizado.