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New treatment option for Squamous Cell Carcinoma of the Head and Neck
Official title Phase II Trial of Neoadjuvant Chemotherapy (NAC) Alone or in Combination With Immunotherapy Vaccine PRGN-2009 in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal (Head and Neck) Cancer
ClinicalTrials.gov ID: NCT06223568
What this study is testing
What is Docetaxel?
Docetaxel is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for 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: Throat cancer is a common tumor that can occur in people infected with the human papilloma virus (HPV). Most people with this cancer survive more than 5 years with standard chemotherapy drugs plus radiation.
- 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 surgically resectable newly diagnosed stage I (cT1-2, N0-1) or II (T1-3, N0-2), M0 oropharyngeal squamous...
- History of HPV-positive status determined by a standard-of-care HPV testing. Note: All participants with high-risk HPV serotypes are eligible.
- Age \>= 18 years.
- ECOG performance status \<= 2.
- Individuals who smoke currently must smoke \ 10 years before study treatment initiation. Former smokers who quit \<10 years before study treatment...
You likely can't join if
- Peripheral motor or sensory neuropathy \> Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v.5 at screening.
- Prior therapy with an investigational drug, live vaccine, chemotherapy, immunotherapy, or any prior radiotherapy (except for palliative bone-directed...
- Prior therapy with any medications or substances that are moderate or strong inducers or moderate or strong inhibitors of cytochrome P450 (CYP3A)...
- History of allergic reactions attributed to compounds of similar chemical or biological composition to drugs used in the study.
- Systemic (intravenous or oral) glucocorticoid (except for physiologic doses of corticosteroids, i.e., \<= the equivalent of prednisone 10 mg/day) or...
- Second malignancy active within the previous 2 years except for indolent or locally curable malignancy that is currently considered cured and/or does...
See the full eligibility criteria
- Histologically or cytologically confirmed surgically resectable newly diagnosed stage I (cT1-2, N0-1) or II (T1-3, N0-2), M0 oropharyngeal squamous cell carcinoma. Note: Pathological report of cancer diagnosis may be...
- History of HPV-positive status determined by a standard-of-care HPV testing. Note: All participants with high-risk HPV serotypes are eligible.
- Age \>= 18 years.
- ECOG performance status \<= 2.
- Individuals who smoke currently must smoke \ 10 years before study treatment initiation. Former smokers who quit \<10 years before study treatment initiation must have smoked \<10 pack years.
- Planned for cancer removal surgery per standard of care (SOC) and individual had agreed for the cancer removal surgery.
- Individuals must have adequate organ and marrow function as defined below:
- Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L
- Hemoglobin (Hgb) \>= 9.0 g/dL
- Platelet count \>= 100 x 10\^9/L
- Creatinine \ =55 mL/min/1.73m\^2 by Cockcroft-Gault formula
- Total bilirubin \<= 1 x ULN, or \<= 3 x ULN in patients with known or suspected Gilbert's Syndrome
- Alanine aminotransferase (ALT) \<= 1.5 x ULN
- Aspartate aminotransferase (AST) \<= 1.5 x ULN
- Individuals serologically positive for human immunodeficiency virus (HIV) must:
- be on effective anti-retroviral therapy for at least 4 weeks; and
- have undetectable viral load; and
- have the CD4 count \>=200 cells/microL; and
- have no reported opportunistic infections or Castleman s disease within 12 months prior to study treatment initiation
- Individuals serologically positive for Hepatitis C virus (HCV) or Hepatitis B virus (HCB) must have an undetectable viral load.
- Individuals of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization, abstinence) for the duration of the study...
- Breastfeeding individuals must be willing to discontinue breastfeeding from study treatment initiation through 2 months after the last dose of the study drug(s).
- Individuals must have a tumor site that is amenable to biopsy and be willing to undergo pre- treatment biopsy for research purposes.
- Individuals must be willing to undergo pre-treatment PET/CT imaging study.
- The ability of an individual to understand and the willingness to sign a written informed consent document.
- Peripheral motor or sensory neuropathy \> Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v.5 at screening.
- Prior therapy with an investigational drug, live vaccine, chemotherapy, immunotherapy, or any prior radiotherapy (except for palliative bone-directed therapy) within 4 weeks prior to the first study drug administration...
- Prior therapy with any medications or substances that are moderate or strong inducers or moderate or strong inhibitors of cytochrome P450 (CYP3A)...
- History of allergic reactions attributed to compounds of similar chemical or biological composition to drugs used in the study.
- Systemic (intravenous or oral) glucocorticoid (except for physiologic doses of corticosteroids, i.e., \<= the equivalent of prednisone 10 mg/day) or other immunosuppressors such as azathioprine or cyclosporin A within 1...
- Second malignancy active within the previous 2 years except for indolent or locally curable malignancy that is currently considered cured and/or does not require an additional standard of care treatment, such as, but...
- Prior allogenic tissue/solid organ transplant.
- History of heart failure.
- Positive beta-human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test performed in females 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.