drugset / Trial / NCT03162731
Nivolumab, Ipilimumab, and Radiation Therapy in Treating Patients With Stage III-IVB Head and Neck Cancer
Phase 0
Completed
24 enrolled
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Bristol-Myers Squibb · collab
NaSingle-groupOpen-labelTreatment
Summary
This pilot clinical trial studies the side effects of nivolumab, ipilimumab and radiation therapy in treating patients with stage IVA-B head and neck cancer. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving nivolumab, ipilimumab, and radiation therapy may work better in treating patients with stage IVA-B head and neck cancer.
Timeline
- Start
- 2017-05-11
- Primary completion
- 2020-09-27
- Completion
- 2022-11-16
Publications
- Johnson JM, Vathiotis IA, Harshyne LA, Ali A, Bar Ad V, Axelrod R, Lorber E, Curry J, Cognetti DM, Luginbuhl AJ, Tuluc M, Keith S, Mahoney MG, Argiris A. Nivolumab and ipilimumab in combination with radiotherapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck. J Immunother Cancer. 2023 Aug;11(8):e007141. doi: 10.1136/jitc-2023-007141.
- Ali AS, Manukian G, Johnson JM, Vathiotis I, Axelrod R, Keith SW, Curry J, Cognetti D, Luginbuhl A, Argiris A, Bar-Ad V. In-Field Toxicity Analysis of a Phase 1 Clinical Trial of Nivolumab and Ipilimumab With Definitive Radiation Therapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck. Int J Radiat Oncol Biol Phys. 2023 Sep 1;117(1):181-185. doi: 10.1016/j.ijrobp.2023.03.065. Epub 2023 Apr 3. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 3 mg/kg | Intravenous |