Title: An Open Label, Randomized, Two Arm Phase III Study of Nivolumab in Combination With Ipilimumab Versus Extreme Study Regimen (Cetuximab + Cisplatin/Carboplatin + Fluorouracil) as First Line Therapy in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)1
Funded by: Bristol-Myers Squibb
Description: The international, open-label, phase 3 CheckMate 651 study (ClinicalTrials.gov Identifier: NCT02741570) is recruiting participants with recurrent or metastatic SCCHN to evaluate the safety and efficacy of nivolumab and ipilimumab as first-line therapy compared with the standard of care EXTREME chemoimmunotherapy regimen.
The study is randomly assigning adult patients who have not received prior systemic cancer therapy for recurrent or metastatic disease, with the exception of patients who have completed chemotherapy as part of multimodal therapy 6 months prior to enrollment, to receive nivolumab plus ipilimumab or cetuximab plus a platinum agent and fluorouracil.
The primary outcome measures are overall survival and progression-free survival. Secondary end points include objective response rate, time to deterioration, and PD-L1 expression as a predictive biomarker for efficacy.
For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/study/NCT02741570.
Status: This study is recruiting patients as of February 24, 2017.
Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody approved by the U.S. Food and Drug Administration as a single agent for the treatment of advanced SCCHN, non-small cell lung cancer, renal cell carcinoma, classical Hodgkin lymphoma, and urothelial carcinoma, and as combination therapy with ipilimumab for advanced melanoma.
Ipilimumab is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for the treatment of advanced melanoma and the adjuvant treatment of cutaneous melanoma with regional lymph node involvement.
- ClinicalTrials.gov. Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Study Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (CheckMate 651). NCT02741570. https://clinicaltrials.gov/ct2/show/study/NCT02741570. Accessed February 24, 2017.