A Study Using Nivolumab, in Combination With Chemotherapy Drugs to Treat Nasopharyngeal Carcinoma (NPC)
A Phase 2 Study Using Chemoimmunotherapy With Gemcitabine, Cisplatin and Nivolumab in Newly Diagnosed Nasopharyngeal Carcinoma (NPC)
About This Trial
This phase II trial tests effects of nivolumab in combination with chemotherapy drugs prior to radiation therapy patients with nasopharyngeal carcinoma (NPC). 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. Chemotherapy drugs, such as gemcitabine and 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 x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Researchers want to find out what effects, good and/or bad, adding nivolumab to chemotherapy has on patients with newly diagnosed NPC. In addition, they want to find out if children with NPC may be treated with less radiation therapy and whether this decreases the side effects of therapy.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
View original clinical language
Treatments Being Tested
Biopsy Procedure
Undergo tissue biopsy
Biospecimen Collection
Undergo blood and stool sample collection
Chest Radiography
Undergo chest x-ray
Cisplatin
Given IV
Computed Tomography
Undergo CT
Echocardiography Test
Undergo ECHO
Electronic Health Record Review
Ancillary studies
Fluciclovine F18
Given IV
Gemcitabine
Given IV
Magnetic Resonance Imaging
Undergo MRI
Multigated Acquisition Scan
Undergo MUGA
Nivolumab
Given IV
Positron Emission Tomography
Undergo PET
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Radiation Therapy
Receive radiation therapy
X-Ray Imaging
Undergo dental x-ray