Phase II Study of Chemotherapy Alone or with Immunotherapy Vaccine PRGN-2009 for Newly Diagnosed HPV-Related Throat Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06223568

Provider View

This clinical trial is testing whether adding an immunotherapy vaccine, PRGN-2009, to standard chemotherapy can improve treatment outcomes for people with newly diagnosed HPV-related throat cancer, potentially avoiding the need for radiation therapy.

Patient Parameters

Program Overview

Throat cancer linked to the human papilloma virus (HPV) is common and usually treated with chemotherapy and radiation. However, radiation can cause serious side effects. This study is exploring whether adding a vaccine called PRGN-2009 to chemotherapy can improve survival without needing radiation. Participants will receive chemotherapy, and some will also receive the vaccine. The study aims to see if this combination can effectively treat the cancer while reducing side effects.

Description

This study focuses on HPV-related throat cancer, which is becoming more common. Standard treatments often involve surgery followed by radiation, but radiation can lead to long-term side effects like difficulty swallowing. This trial is testing a new approach using chemotherapy before surgery, with or without an additional vaccine, to see if it can effectively treat the cancer and avoid radiation.

Participants will be randomly assigned to receive either chemotherapy alone or chemotherapy with the PRGN-2009 vaccine. Chemotherapy involves drugs given through a vein, while the vaccine is injected under the skin. The treatment will be given in cycles, and participants will have surgery to remove the cancer after completing the treatment.

The study will monitor how well the cancer responds to the treatment and assess participants' quality of life, swallowing function, and hearing. Follow-up visits will occur at 3, 6, 12, and 24 months after surgery to track recovery and any recurrence of cancer.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with newly diagnosed, surgically removable stage I or II HPV-positive throat cancer.
  • Must have a good overall health status and adequate organ function.
  • Current smokers must have a smoking history of less than 10 pack years, or have quit smoking more than 10 years ago.
  • Must be planned for cancer removal surgery and agree to it.
  • Must have adequate blood counts and organ function as determined by specific medical tests.
  • Must not have active HIV, Hepatitis B, or Hepatitis C infections, or must have these conditions under control.
  • Women of childbearing potential must agree to use effective contraception during and after the study.
  • Men must agree to use contraception during and after the study.
  • Must be willing to provide a tumor sample and undergo imaging studies before treatment.
  • Must understand and agree to the study by signing a consent form.

Exclusion Criteria

  • Severe nerve damage or neuropathy.
  • Recent treatment with investigational drugs, chemotherapy, or immunotherapy.
  • Use of certain medications that affect liver enzymes within two weeks before starting the study.
  • Allergic reactions to similar drugs used in the study.
  • Use of systemic steroids or immunosuppressive drugs shortly before the study.
  • History of another active cancer within the past two years, except for certain skin or bladder cancers.
  • Previous organ transplant.
  • History of heart failure.
  • Positive pregnancy test in women of childbearing potential.
  • Uncontrolled medical conditions that could increase risk during the study.

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