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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT06223568
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Docetaxel — DRUG
    Docetaxel 75 mg/m\^2 will be administered over 60 (+/-10) minutes.
  • Cisplatin — DRUG
    Cisplatin 75 mg/m\^2 will be administered over 120 (+/-10) minutes.
  • PRGN-2009 — DRUG
    PRGN-2009 will be administered in Arm 2 participants only as an SQ injection in the arm at a dose of 1 mL nominally containing 5x10\^11 viral particles (VP) on Day -7 (+/-3 days) of Cycle 1, Day 11 (+/-3 days) of Cycles 1, 2, and 3.

Study Details

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. ...

Key Dates

Start date
Jun 10, 2024
Status verified
May 2026
Primary completion
Jan 10, 2028
Completion
Jan 10, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    DC (docetaxel + cisplatin)
  • Experimental: Arm 2
    DCP (docetaxel + cisplatin + PRGN-2009)

Primary Outcome Measure

Determine the rate of pCR with NAC (DC) alone or in combination with PRGN-2009 (DCP) in participants with newly diagnosed HPV-associated OPSCC [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
National Cancer Institute Referral Office
888-624-1937

Find similar trials in Bethesda, MD

By research site
National Institutes of Health Clinical Center· Bethesda, MD

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