Phase 3 N=74 Randomized Treatment

Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer

Squamous Cell Carcinoma of the Head and Neck

Bottom Line

View on ClinicalTrials.gov: NCT03349710 ↗

Enrolled (actual)

Serious AEs

38.4%

Results posted

Aug 2021

Primary outcome: Primary: Number of Participants With an Adverse Event (AE) — 12; 10; 27; 24 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Nivolumab (Biological); Cetuximab (Drug); Cisplatin (Drug); Radiotherapy (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: Oct 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With an Adverse Event (AE)	12; 10; 27; 24	—
PRIMARY Number of Participants With an Serious Adverse Event (SAE)	5; 5; 9; 6	—
PRIMARY Number of Participants With an Adverse Event Leading to Discontinuation	2; 3; 8; 4	—
PRIMARY Number of Participants With an Adverse Event Leading to Dose Modification	0; 0; 0; 0	—
PRIMARY Number of Participants With Select Adverse Events	4; 3; 3; 1; 1; 2	—
PRIMARY Number of Participants With an Immune-mediated Adverse Event (IMAE)	1; 0; 3; 0; 0; 0	—
PRIMARY Time to Onset and Time to Resolution of Immune-related Adverse Events	—	—
PRIMARY Number of Participants Who Experienced Death	2; 2; 2; 1	—
PRIMARY Number of Participants With an Abnormality in Specific Thyroid Tests	5; 1; 7; 1; 5; 1	—
PRIMARY Number of Participants With an Abnormality in Specific Liver Tests	2; 0; 0; 0; 1; 0	—

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

Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria

Histologically proven squamous cell carcinoma of the head and neck (SCCHN) from one of the following primary sites: oral cavity, oropharynx, hypopharynx, and larynx
Locally advanced disease which is unresectable, or resectable but suitable for an organ sparing approach
No previous radiotherapy or systemic treatment for SCCHN

Exclusion Criteria

Carcinoma originating in the nasopharynx or paranasal sinus, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histology (e.g., mucosal melanoma), squamous cell carcinoma of unknown primary
Clinical or radiological evidence of metastatic disease
Prior radiotherapy that overlaps with radiation fields

Other protocol defined inclusion/exclusion criteria could apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03349710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.