Study on Immunotherapy vs. Observation in Patients with HPV-Related Throat Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03811015
This clinical trial is exploring whether adding immunotherapy (nivolumab) after standard treatment with chemotherapy and radiation can improve survival in patients with HPV-positive throat cancer that has spread to nearby tissues or lymph nodes.
Patient Parameters
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Program Overview
This study aims to find out if using the immunotherapy drug nivolumab after chemotherapy and radiation can help patients with HPV-positive throat cancer live longer and stay cancer-free longer. Chemotherapy drugs like cisplatin work by stopping cancer cells from growing, while radiation uses high-energy rays to kill cancer cells. Immunotherapy with nivolumab may help the immune system attack cancer cells and prevent them from growing and spreading. Researchers want to see if this combination works better than just chemotherapy and radiation alone.
Description
The study is divided into two main groups:
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Group A: Patients receive chemotherapy (cisplatin) and radiation therapy for 7 weeks. After this, they receive nivolumab once every 4 weeks for up to 12 months, as long as the cancer does not progress or cause severe side effects.
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Group B: Patients receive the same chemotherapy and radiation therapy but are then observed without additional treatment. If their cancer progresses within 12 months, they may switch to receive nivolumab.
All participants will have regular scans and tests to monitor their health and the cancer's response to treatment. After completing the study treatment, patients will have follow-up visits every 3-6 months for 3 years, and then annually for up to 10 years.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have HPV-positive throat cancer that has spread to nearby tissues or lymph nodes.
- Must not have allergies to nivolumab or similar drugs.
- Must not have had previous treatment for this type of cancer.
- Must not have other serious health conditions that could interfere with treatment.
- Must have adequate blood counts and organ function.
- Women must not be pregnant or breastfeeding and must use effective birth control during and after treatment.
- Must have measurable cancer that can be tracked with scans.
- Must not have active autoimmune diseases that require treatment.
- Must not have active infections like hepatitis or HIV unless well-controlled.
- Must not be taking other experimental treatments.
- Must not have significant hearing loss that would prevent the use of cisplatin.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Thomas Hospital | 36532 | Fairhope | Alabama |
| Mobile Infirmary Medical Center | 36607 | Mobile | Alabama |
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
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