RECRUITING

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

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Conditions

Squamous Cell Carcinoma of the Head and NeckOropharynxHuman Papillomavirus VirusesDrug TherapyCancer VaccineNeoadjuvant ChemotherapyOropharynx CancerHuman PapillomavirusTherapeutic Vaccine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. But radiation can cause serious adverse effects. Researchers believe that adding a vaccine (PRGN-2009) to this drug therapy may improve survival without the need for radiation. Objective: To test a study vaccine combined with standard chemotherapy in patients with HPV-associated throat cancers. Eligibility: People aged 18 years and older with newly diagnosed throat cancer associated with HPV. Design: Participants will be screened. They will have a physical exam and blood tests. They will have imaging scans and tests of their heart function and hearing. They will provide a sample of tissue from their tumor. A recent sample may be used; if none is available, a new sample will be taken. All participants will get two common drugs for treating cancer. These drugs are given through a tube attached to a needle inserted into a vein in the arm. Participants will receive these drugs on the first day of three 3-week cycles. Half of the participants will also get the vaccine. PRGN-2009 is injected under the skin in the arm. They will get these shots 4 times: 7 days before the start of the first cycle and on the 11th day of each cycle. Participants will have standard surgery to remove their tumors 3 to 6 weeks after completing the study treatment. They will have follow-up visits 3, 6, 12, and 24 months after their surgery. ...

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

Quick Facts

Study Start:2024-06-10
Study Completion:2028-01-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06223568

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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 from the primary tumor or from a metastatic cervical lymph node.
  2. * History of HPV-positive status determined by a standard-of-care HPV testing. Note: All participants with high-risk HPV serotypes are eligible.
  3. * Age \>= 18 years.
  4. * ECOG performance status \<= 2.
  5. * Participants who smoke currently must smoke \<10 pack years. Note: Former smokers with any pack-year history are eligible if quit smoking \>10 years before study treatment initiation.
  6. * Planned for cancer removal surgery per standard of care (SOC) and participant had agreed for the cancer removal surgery.
  7. * Participants must have adequate organ and marrow function as defined below:
  8. * Absolute neutrophil count (ANC) \>= 1.5 (SqrRoot) 10\^9/L
  9. * Hemoglobin (Hgb) \>= 9.0 g/dL
  10. * Platelet count \>= 100 (SqrRoot) 10\^9/L
  11. * Creatinine \<= 1.2 (SqrRoot) upper limit of normal (ULN) OR calculated creatinine clearance \>=55 mL/min/1.73m\^2 by Cockcroft-Gault formula
  12. * Total bilirubin \<= 1 (SqrRoot) ULN.
  13. * Alanine aminotransferase (ALT) \<= 1.5 (SqrRoot) ULN
  14. * Aspartate aminotransferase (AST) \<= 1.5 (SqrRoot) ULN
  15. * Participants serologically positive for human immunodeficiency virus (HIV) must:
  16. * be on effective anti-retroviral therapy for at least 4 weeks; and
  17. * have undetectable viral load; and
  18. * have the CD4 count \>=200 cells/microL; and
  19. * have no reported opportunistic infections or Castleman s disease within 12 months prior to study treatment initiation
  20. * Participants serologically positive for Hepatitis C virus (HCV) or Hepatitis B virus (HCB) must have an undetectable viral load.
  21. * Women of child-bearing potential (WOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization, abstinence) for the duration of the study treatment and up to 2 months after the last dose of PRGN-2009 and an effective method of contraception (barrier, hormonal, intrauterine device (IUD), surgical sterilization, abstinence) for 14 months after the last dose of cisplatin/docetaxel. Note: WOCBP is defined as any woman who has experienced menarche and has not had a hysterectomy or bilateral oophorectomy or is not postmenopausal (amenorrheic 12 months or more following cessation of exogenous hormonal treatments; if \<50 years old and need follicle stimulating hormone \[FSH\] in the post-menopausal range).
  22. * Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 2 months after the last dose of the study drug(s).
  23. * Participants must have a tumor site that is amenable to biopsy and be willing to undergo pre- treatment biopsy for research purposes.
  24. * Participants must be willing to undergo pre-treatment PET/CT imaging study.
  25. * The ability of a participant to understand and the willingness to sign a written informed consent document.
  1. * Peripheral motor or sensory neuropathy \> Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v.5 at screening.
  2. * 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. Note: Participants may continue adjuvant hormonal therapy in the setting of a definitively treated cancer (e.g., breast).
  3. * Prior therapy with any medications or substances that are moderate or strong inducers or moderate or strong inhibitors of cytochrome P450 (CYP3A)
  4. * History of allergic reactions attributed to compounds of similar chemical or biological composition to drugs used in the study.
  5. * 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 week prior to study treatment initiation. Note: Glucocorticoids as premedication for contrast-enhanced studies are allowed.
  6. * 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 cell carcinoma, superficial bladder cancer, or cervical carcinoma in situ, or an incidental histological finding of prostate cancer.
  7. * Prior allogenic tissue/solid organ transplant.
  8. * History of heart failure.
  9. * Positive beta-human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test performed in females of childbearing potential at screening.
  10. * 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 changes) that would potentially increase risk for the participant.

Contacts and Locations

Study Contact

Melissa Missy L Wheatley
CONTACT
(240) 858-3391
melissa.wheatley@nih.gov
Clint T Allen, M.D.
CONTACT
(301) 402-4216
clint.allen@nih.gov

Principal Investigator

Clint T Allen, M.D.
PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Clint T Allen, M.D., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-10
Study Completion Date2028-01-10

Study Record Updates

Study Start Date2024-06-10
Study Completion Date2028-01-10

Terms related to this study

Keywords Provided by Researchers

  • Neoadjuvant Chemotherapy
  • Oropharynx Cancer
  • Human Papillomavirus
  • Therapeutic Vaccine

Additional Relevant MeSH Terms

  • Squamous Cell Carcinoma of the Head and Neck
  • Oropharynx
  • Human Papillomavirus Viruses
  • Drug Therapy
  • Cancer Vaccine