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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Squamous Cell Carcinoma of the Head and Neck

Treatments: Drug: Cetuximab; Drug: Cisplatin; Radiation: Radiotherapy; Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03349710

CA209-9TM

2017-002676-87 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 4 patient groups

Arm A

Experimental group

Description:

Cohort 1

Treatment:

Biological: Nivolumab

Radiation: Radiotherapy

Arm B

Experimental group

Description:

Cohort 1

Treatment:

Radiation: Radiotherapy

Drug: Cetuximab

Arm C

Experimental group

Description:

Cohort 2

Treatment:

Biological: Nivolumab

Radiation: Radiotherapy

Drug: Cisplatin

Arm D

Experimental group

Description:

Cohort 2

Treatment:

Radiation: Radiotherapy

Drug: Cisplatin