Nivolumab Results Prompt Early Halt to Metastatic Head and Neck Cancer Trial

Nivolumab (Opdivo) demonstrated superior overall survival (OS) among patients diagnosed with metastatic, platinum-refractory head and neck squamous cell carcinoma, prompting a decision to halt the randomized phase III CheckMate-141 clinical trial, Bristol-Myers Squibb has announced.

“With the results of CheckMate-141, Opdivo moves closer to providing a potential treatment option for patients with head and neck cancer, a cancer with high unmet need and limited treatment options,” said Michael Giordano, MD, head of Oncology Development at Bristol-Myers Squibb, in a press release.

Nivolumab is a programmed cell death receptor 1 (PD-1) immune checkpoint inhibitor. It is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma, metastatic non-small cell lung cancer (NSCLC) refractory to platinum-based therapy, and advanced renal cell carcinoma (RCC) among patients who have received prior antiangiogenic therapy.

CheckMate-141 was an open-label, randomized phase III clinical trial comparing 3 mg/kg nivolumab against investigator’s choice of cetuximab (Erbitux), methotrexate, or docetaxel in 361 patients with platinum-therapy-refractory squamous cell carcinoma of the head and neck. The trial randomly assigned participants 2:1 to receive either nivolumab intravenously every two weeks, or investigator’s choice therapy.

Participating investigators were informed of the analysis and resulting decision to halt the trial early to allow cross-over to nivolumab treatment among patients in the study’s control arm. The company announced plans to “complete a full evaluation of the final CheckMate-141 data, and work with investigators on the future presentation and publication of the results.”

Patients administered nivolumab should be monitored for clinical or radiographic signs or symptoms of potentially fatal immune-mediated pneumonitis, as well as immune-mediated colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, rash, encephalitis, or other immune-mediated adverse reactions, including uveitis, pancreatitis, facial and abducens nerve paresis, demyelination, polymyalgia rheumatica, autoimmune neuropathy, and Guillain-Barré syndrome, among others. Nivolumab may also cause harm to a fetus if administered to a pregnant woman, the company cautioned.