At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed squamous cell carcinoma of head and neck from oral cavity, oropharynx, hypopharynx, or larynx
- ✓Locally advanced disease that is unresectable or resectable but suitable for organ-sparing approach
- ✓No previous radiotherapy or systemic treatment for SCCHN
- ✕Primary tumor from nasopharynx, paranasal sinus, skin, or salivary gland
- ✕Non-squamous histology (e.g., mucosal melanoma) or squamous cell carcinoma of unknown primary
- ✕Clinical or radiological evidence of metastatic disease
- ✕Prior radiotherapy overlapping with planned radiation fields
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Participants With Cisplatin Ineligible and Cisplatin Eligible Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)
In Brief
A Phase 3 clinical trial evaluating Nivolumab, Cetuximab, and 2 other interventions for Squamous Cell Carcinoma of the Head and Neck. Completed, enrolled 74 participants across 55 sites in 10 countries.
Detailed Summary
This study has two, independent, cohorts, both in locally advanced squamous cell head and neck cancer. The purpose of the first cohort is to determine whether nivolumab in combination with radiotherapy is more effective than cetuximab in combination with radiotherapy, in subjects who are ineligible for cisplatin. The purpose of the second cohort is to determine whether nivolumab, cisplatin, and radiotherapy is more effective than cisplatin and radiotherapy in subjects who are eligible to receive cisplatin
Study Details
Timeline
Interventions
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