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New treatment option for Stage II Squamous Cell Carcinoma of the Head and Neck
Official title Pembrolizumab + N-803 Alone or in Combination With PD-L1 t-haNK Cells for Resectable Head and Neck Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT06161545
What this study is testing
What is PD-L1 t-haNK cells?
PD-L1 t-haNK cells is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for stage ii squamous cell carcinoma of the head and neck.
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
- Background: Squamous cell carcinoma is a type of cancer that can cause tumors on the head and neck (HNSCC). Even with treatment, less than 50% of people with certain types of HNSCC survive for 5 years.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join if
- Histologically or cytologically confirmed previously untreated intermediate/high risk, p16-negative (if oropharyngeal primary tumor), squamous cell...
- Age \>= 18 years.
- ECOG performance status \<= 1.
- Planned for cancer removal surgery per standard of care.
- Participants must have adequate organ and marrow function as defined below:
You likely can't join if
- History of allergic reactions attributed to compounds of similar chemical or biological composition to drugs used in the study.
- Active immunosuppressive treatment equivalent of \> 10mg of prednisone daily. Note: Short-course systemic corticosteroids (e.g., prevention/treatment...
- History of autoimmune disease with the exception of controlled thyroid disease, psoriasis not requiring medications, vitiligo, and alopecia.
- Participants with a history of hepatitis B (HBV).
- Prior malignancy active within the previous 2 years except for locally curable cancer that is currently considered cured and does not require an...
- Prior therapy with the investigational drug within 2 weeks prior to the treatment initiation.
See the full eligibility criteria
- Histologically or cytologically confirmed previously untreated intermediate/high risk, p16-negative (if oropharyngeal primary tumor), squamous cell carcinoma of the head and neck (T1-T4, N0-N3, M0 stage II, III or IV)...
- Age \>= 18 years.
- ECOG performance status \<= 1.
- Planned for cancer removal surgery per standard of care.
- Participants must have adequate organ and marrow function as defined below:
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<= 3.0 x upper limit of normal (ULN)
- Total bilirubin \<= 1 x ULN. Note: Participants with Gilbert's syndrome can have total bilirubin \< 3.0 mg/dL
- Absolute neutrophil count (ANC) \>= 1.0 x 10\^9/L
- Hemoglobin (Hgb) \>= 10.0 g/dL
- Platelet count \>= 100 x 10\^9/L
- Prothrombin time (PT) and partial thromboplastin time (PTT) \<= 1 x ULN. Note: Participants with prolonged PTT determined to be due to lupus anticoagulant are eligible
- Creatinine \<= 1.5 x ULN
- Participants with a history of human immunodeficiency virus (HIV) infection must:
- be on effective anti-retroviral therapy; and
- have the viral load \< 400 copies/mL; and
- have the CD4 count \> 150 cells/microL
- Participants with a history of Hepatitis C virus (HCV) infection must
- received curative treatment; and
- have an undetectable viral load.
- Individuals of child-bearing potential (IOCBP) and those who can father children must agree to use an effective method of contraception (barrier, hormonal, intrauterine device (IUD), surgical sterilization) for the...
- Nursing participants must be willing to discontinue nursing from study treatment initiation through 4 months after the last dose of the study drug(s).
- Participants must have a primary tumor site that is amenable to biopsy and be willing to undergo pre-and post-treatment biopsies.
- The ability of a participant to understand and the willingness to sign a written informed consent document.
- History of allergic reactions attributed to compounds of similar chemical or biological composition to drugs used in the study.
- Active immunosuppressive treatment equivalent of \> 10mg of prednisone daily. Note: Short-course systemic corticosteroids (e.g., prevention/treatment for transfusion reaction) or use for a non-cancer indication (e.g...
- History of autoimmune disease with the exception of controlled thyroid disease, psoriasis not requiring medications, vitiligo, and alopecia.
- Participants with a history of hepatitis B (HBV).
- Prior malignancy active within the previous 2 years except for locally curable cancer that is currently considered cured and does not require an additional standard of care treatment, such as cutaneous basal or squamous...
- Prior therapy with the investigational drug within 2 weeks prior to the treatment initiation.
- Pregnancy (confirmed with Beta-human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test performed in individuals of childbearing potential at screening).
- Uncontrolled intercurrent illness or medical condition(s) evaluated by medical history and physical exam or situations that are not stable (e.g., recent hospitalization, Emergency Room visit or undergoing medication...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, 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.