Intensity-Modulated Radiation Therapy & Nivolumab for Recurrent or Second Primary Head & Neck Squamous Cell Cancer

Phase 2 Completed 62 enrolled Emory University Bristol-Myers Squibb · collab Medical College of Wisconsin · collab National Cancer Institute (NCI) · collab National Institutes of Health (NIH) · collab The Cleveland Clinic · collab

NaSingle-groupOpen-labelTreatment

Summary

This phase II trial studies how well intensity-modulated radiotherapy and nivolumab work together in treating patients with head and neck squamous cell cancer that has come back. Intensity-modulation radiation therapy uses varying intensities of radiation beams to kill cancer cells and shrink tumors, thereby reducing the damage to nearby healthy tissue. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving intensity-modulated radiation therapy and nivolumab may work better at treating head and neck squamous cell cancer.

Timeline

Start: 2018-06-28
Primary completion: 2022-07-25
Completion: 2023-09-07

Outcome

Met primary endpoint

paper rejecting the null hypothesis of 1-year PFS rate of less than 43.8% with 1-arm log-rank test P = .002 PMID 38780927 ↗

paper suggested a promising improvement in PFS over historical controls. PMID 38780927 ↗

Publications

Saba NF, Wong SJ, Nasti T, McCook-Veal AA, McDonald MW, Stokes WA, Anderson AM, Ekpenyong A, Rupji M, Abousaud M, Rudra S, Bates JE, Remick JS, Joshi NP, Woody NM, Awan M, Geiger JL, Shreenivas A, Samsa J, Ward MC, Schmitt NC, Patel MR, Higgins KA, Teng Y, Steuer CE, Shin DM, Liu Y, Ahmed R, Koyfman SA. Intensity-Modulated Reirradiation Therapy With Nivolumab in Recurrent or Second Primary Head and Neck Squamous Cell Carcinoma: A Nonrandomized Controlled Trial. JAMA Oncol. 2024 Jul 1;10(7):896-904. doi: 10.1001/jamaoncol.2024.1143.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nivolumab	Monoclonal antibody	480 mg	Intravenous