Testing Immunotherapy Versus Observation in Patients With HPV Throat Cancer (NCT03811015)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. STEP 1: Age \>= 18 years
2. STEP 1: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
3. STEP 1: Patients must have oropharynx cancer (American Joint Committee on Cancer \[AJCC\] 8) that is p16-positive by immunohistochemistry OR p16 equivocal by IHC and HPV positive by in situ hybridization with the following criteria: \>= 10 pack-years, stage T1-2N2-N3 or T3-4N0-3 (less than 10 pack-years is considered a non-smoker) OR \< 10 pack-years, stage T4N0-N3 or T1-3N2-3
4. STEP 1: Patients must not have known hypersensitivity to nivolumab or compounds of similar chemical or biologic composition.
5. STEP 1: Patients with a history of allergic reactions attributed to platinum-based chemotherapy agents are excluded.
6. STEP 1: Patients must not have had prior systemic therapy, radiation treatment or surgery for p16 positive oropharyngeal squamous cell carcinoma (OPSCC).
7. NOTE: Patients who had resection of T1 or T2 carcinoma with no radiation or chemotherapy are eligible if surgery was done 5 years prior to enrollment
8. STEP 1: Patients must not have received previous irradiation for head and neck tumor, skull base, or brain tumors.
9. STEP 1: Patients must not receive investigational agents within 4 weeks of enrollment or at any time while on study.
10. STEP 1: Patients with evidence of distant metastases or leptomeningeal disease (LMD) are excluded.
11. STEP 1: Patients with uncontrolled inter-current illnesses which in the opinion of the investigator will interfere with the ability to undergo therapy including chemotherapy are excluded.
12. STEP 1: Patients with a history of prior or second malignancy are excluded, with the exception of curatively treated non-melanoma skin cancer, or curatively treated cervical cancer; additionally, patients curatively treated for malignancy who remain disease-free at \> 2 years of follow up, are not excluded.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (727 Sites)

• Thomas Hospital — Fairhope, Alabama
• Mobile Infirmary Medical Center — Mobile, Alabama
• Anchorage Associates in Radiation Medicine — Anchorage, Alaska
• Anchorage Radiation Therapy Center — Anchorage, Alaska
• Alaska Breast Care and Surgery LLC — Anchorage, Alaska
• Alaska Oncology and Hematology LLC — Anchorage, Alaska
• Alaska Women's Cancer Care — Anchorage, Alaska
• Anchorage Oncology Centre — Anchorage, Alaska
• Katmai Oncology Group — Anchorage, Alaska
• Providence Alaska Medical Center — Anchorage, Alaska
• Fairbanks Memorial Hospital — Fairbanks, Alaska
• CTCA at Western Regional Medical Center — Goodyear, Arizona
• Kingman Regional Medical Center — Kingman, Arizona
• Cancer Center at Saint Joseph's — Phoenix, Arizona
• Mercy Hospital Fort Smith — Fort Smith, Arkansas
• CHI Saint Vincent Cancer Center Hot Springs — Hot Springs, Arkansas
• Kaiser Permanente-Deer Valley Medical Center — Antioch, California
• Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California
• PCR Oncology — Arroyo Grande, California
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California
• Mercy Cancer Center - Carmichael — Carmichael, California
• Mercy San Juan Medical Center — Carmichael, California
• Epic Care-Dublin — Dublin, California
• Kaiser Permanente Dublin — Dublin, California
• Mercy Cancer Center - Elk Grove — Elk Grove, California

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.