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)
Overview
- Phase
- Phase 3
- Intervention
- Nivolumab
- Conditions
- Squamous Cell Carcinoma of the Head and Neck
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 74
- Locations
- 22
- Primary Endpoint
- Number of Participants With an Adverse Event Leading to Dose Modification
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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
Investigators
Eligibility Criteria
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
Arms & Interventions
Arm A
Cohort 1
Intervention: Nivolumab
Arm A
Cohort 1
Intervention: Radiotherapy
Arm B
Cohort 1
Intervention: Cetuximab
Arm B
Cohort 1
Intervention: Radiotherapy
Arm C
Cohort 2
Intervention: Nivolumab
Arm C
Cohort 2
Intervention: Cisplatin
Arm C
Cohort 2
Intervention: Radiotherapy
Arm D
Cohort 2
Intervention: Cisplatin
Arm D
Cohort 2
Intervention: Radiotherapy
Outcomes
Primary Outcomes
Number of Participants With an Adverse Event Leading to Dose Modification
Time Frame: 30 Days
Number of Participants with an Adverse Event Leading to dose modification
Number of Participants With Select Adverse Events
Time Frame: 30 Days
Number of Participants with select adverse events. Select Adverse events include: gastrointestinal, hepatic, hypersensitivity/infusion reaction, pulmonary, renal, or skin.
Number of Participants Who Experienced Death
Time Frame: 100 days
Number of Participants who experienced death
Number of Participants With an Abnormality in Specific Liver Tests
Time Frame: 30 days
Number of participants with an abnormality in specific liver tests
Number of Participants With an Serious Adverse Event (SAE)
Time Frame: 30 days
Number of Participants with an Serious Adverse Event (SAE)
Number of Participants With an Adverse Event Leading to Discontinuation
Time Frame: 30 Days
Number of Participants with an Adverse Event Leading to Discontinuation
Number of Participants With an Adverse Event (AE)
Time Frame: 30 Days
Number of Participants with an Adverse Event
Number of Participants With an Immune-mediated Adverse Event (IMAE)
Time Frame: 100 days
Number of Participants with an immune-mediated adverse event (IMAE)
Time to Onset and Time to Resolution of Immune-related Adverse Events
Time Frame: 100 days
Time to onset and time to resolution of immune-related adverse events
Number of Participants With an Abnormality in Specific Thyroid Tests
Time Frame: 30 Days
Number of participants with an abnormality in specific thyroid tests