Nivolumab + Chemoradiation for Nasopharyngeal Cancer
Trial Summary
What is the purpose of this trial?
This phase II trial studies how well nivolumab and chemoradiotherapy works in treating patients with stage II-IVB nasopharyngeal cancer. Monoclonal antibodies, such as nivolumab, may block tumor growth in different ways by targeting certain cells. Chemoradiotherapy is the combination of chemotherapy and radiation therapy and may prevent the cancer from spreading when combined with nivolumab. Giving nivolumab and chemoradiotherapy may work better in treating patients with stage II-IVB nasopharyngeal cancer.
Research Team
Sue S. Yom
Principal Investigator
University of California, San Francisco
Eligibility Criteria
Adults (β₯18 years) with stage II-IVB nasopharyngeal carcinoma, who can undergo radiation therapy and have no severe allergies to immunotherapy or chemotherapy. They must not have other active cancers, untreated brain metastases, recent monoclonal antibody treatment, or certain autoimmune diseases. Participants need functioning major organs and agree to use effective contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nivolumab intravenously and undergo chemoradiotherapy with cisplatin and radiation therapy
Adjuvant Therapy
Participants receive adjuvant nivolumab treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Survival and disease status are collected for up to an additional 4 years
Treatment Details
Interventions
- Cisplatin
- Nivolumab
- Radiation Therapy
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sue Yom
Lead Sponsor
National University of Singapore
Collaborator
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
National University Cancer Institute, Singapore
Collaborator