OncoMatch/Clinical Trials/NCT06868433
TMV Vaccine Therapy Alone and With Pembrolizumab for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer
Is NCT06868433 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Autologous Tumor Membrane Vesicles Vaccine and Pembrolizumab for clinical stage iv hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8.
Treatment: Autologous Tumor Membrane Vesicles Vaccine · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Allowed: CDKN2A p16 positive
p16 positive and negative allowed. Oropharyngeal tumors must have p16 or human papillomavirus (HPV) testing done
Allowed: HPV HPV positive
Oropharyngeal tumors must have p16 or human papillomavirus (HPV) testing done
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: chemotherapy — standard of care
Recurrent and/or metastatic HNSCC that has failed standard chemotherapy
Must have received: immunotherapy — standard of care
Recurrent and/or metastatic HNSCC that has failed...immunotherapy
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1,500 cells/uL; Platelets ≥ 100,000/uL; Hemoglobin ≥ 9.0g/dL (may receive prbc transfusion)
Kidney function
Serum creatinine ≤ 1.5 x ULN; Calculated creatinine clearance of ≥ 50 mL/min
Liver function
Total bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 2.5 x ULN; Albumin ≥ 3.0 g/dL
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 ULN; AST and ALT ≤ 2.5 x ULN; Albumin ≥ 3.0 g/dL; Serum creatinine ≤ 1.5 x ULN; Calculated creatinine clearance of ≥ 50 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Emory University Hospital Midtown · Atlanta, Georgia
- Emory University Hospital/Winship Cancer Institute · Atlanta, Georgia
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