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New treatment option for Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma...
Official title TMV Vaccine Therapy Alone and With Pembrolizumab for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer
ClinicalTrials.gov ID: NCT06868433
What this study is testing
What is Autologous Tumor Membrane Vesicles Vaccine?
Autologous Tumor Membrane Vesicles Vaccine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for clinical stage iv hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8.
Also referred to as Autologous TDMV-derived Vaccine, Autologous TMV Vaccine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 1 year
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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 people must have progressed on ≥ 2 lines of...
You likely can't join if
- 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
- people with any active autoimmune disease or history of known or suspected autoimmune disease except for people with vitiligo, resolved childhood...
- people with a condition requiring systemic treatment with either corticosteroids (\> 10mg daily prednisone equivalents) or other immunosuppressive...
See the full eligibility criteria
- 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...
- 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 people must have progressed on ≥ 2 lines of standard of care prior to starting trial therapy. For patients who have...
- 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...
- 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...
- 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 people 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 people must agree to use adequate contraception (e.g., condoms; abstinence) for the duration of study treatment and 3 months after completion
- Female people of childbearing age must have a negative serum pregnancy test at study entry
- Patients who have received prior pembrolizumab are eligible
- 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
- people with any active autoimmune disease or history of known or suspected autoimmune disease except for people with vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism due to...
- people 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...
- 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 people receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.