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Testing Immunotherapy Versus Observation in Patients With HPV Throat Cancer

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 years later Jan 1, 2027 → Jan 31, 2030
See other at-risk trials from National Cancer Institute (NCI)

Record History

The 50 most recent of 622 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jan 1, 2027 to Jan 31, 2030 Site details revised at 51 of 727 sites Show 1 more changeShow less
    • Site details revised at 51 of 727 sites
  2. Study sites: 728 to 727v621
  3. Study sites revised (728)v620 See this version in full on ClinicalTrials.gov ↗
  4. Study sites revised (728)v619 See this version in full on ClinicalTrials.gov ↗
  5. Re-verified, no change to tracked fieldsv618
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites revised (728)v617 See this version in full on ClinicalTrials.gov ↗
  2. Study sites: 729 to 728v616
  3. Study sites revised (729)v615 See this version in full on ClinicalTrials.gov ↗
  4. Re-verified, no change to tracked fieldsv614
  5. Study sites: 730 to 729v613
  6. 40 versions Re-verified since Feb 11, 2026, no change to tracked fieldsv573-v612
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase III trials studies whether maintenance immunotherapy (nivolumab) following definitive treatment with radiation and chemotherapy (cisplatin) result in significant improvement in overall survival (time being alive) and progression-free survival (time being alive without cancer) for patients with intermediate risk human papillomavirus (HPV) positive oropharynx cancer (throat cancer) that has spread to nearby tissue or lymph nodes. Drugs used in chemotherapy such as cisplatin work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether chemotherapy and radiation therapy followed by maintenance nivolumab therapy works better than chemotherapy and radiation therapy alone in treating patients with HPV positive oropharyngeal cancer.
Trial Details
NCT Number NCT03811015
Lead Sponsor National Cancer Institute (NCI)
Conditions Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Enrollment 636 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov