Testing Immunotherapy Versus Observation in Patients With HPV Throat Cancer (NCT03811015)
A Phase III Randomized Study of Maintenance Nivolumab Versus Observation in Patients With Locally Advanced, Intermediate Risk HPV Positive OPSCC
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Thomas Hospital — Fairhope, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (727 Sites)
Showing the first 25 of 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.
More studies in Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Explore by condition: All Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.