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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 August 2021
• Main ID: NCT03349710
• Date of registration: 17/11/2017
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer
• Scientific title: 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)
• Date of first enrolment: December 15, 2017
• Target sample size: 74
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03349710
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Australia, Brazil, Canada, Colombia, France, Italy, Japan, Korea, Republic of, Poland, Romania, Russian Federation, Spain, Taiwan, Turkey, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Squamous Cell Carcinoma of the Head and Neck

Intervention(s)

Biological: Nivolumab

Drug: Cetuximab

Drug: Cisplatin

Radiation: Radiotherapy

Primary Outcome(s)

Number of Participants With an Adverse Event Leading to Discontinuation [Time Frame: 30 Days]

Time to Onset and Time to Resolution of Immune-related Adverse Events [Time Frame: 100 days]

Number of Participants With an Immune-mediated Adverse Event (IMAE) [Time Frame: 100 days]

Number of Participants With an Adverse Event Leading to Dose Modification [Time Frame: 30 Days]

Number of Participants With an Abnormality in Specific Liver Tests [Time Frame: 30 days]

Number of Participants With an Adverse Event (AE) [Time Frame: 30 Days]

Number of Participants Who Experienced Death [Time Frame: 100 days]

Number of Participants With an Serious Adverse Event (SAE) [Time Frame: 30 days]

Number of Participants With an Abnormality in Specific Thyroid Tests [Time Frame: 30 Days]

Number of Participants With Select Adverse Events [Time Frame: 30 Days]

Secondary ID(s)

2017-002676-87

CA209-9TM

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ono Pharmaceutical Co. Ltd

Results

• Results available: Yes
• Date Posted: 09/08/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03349710