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 Squibb74 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Squamous Cell Carcinoma of the Head and Neck

Interventions

Nivolumab

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (55)

Pinnacle Research Group, Llc

Anniston, Alabama, United States

Cancer Treatment Centers of Phoneix

Goodyear, Arizona, United States

University of Arizona Cancer Center

Tucson, Arizona, United States

UCLA Health

Los Angeles, California, United States

Cancer Care - Torrance Memorial Physician Network

Redondo Beach, California, United States

Outcomes

Primary Outcomes

Number of Participants With an Adverse Event (AE)

Number of Participants with an Adverse Event

Time frame: 30 Days

Number of Participants With an Serious Adverse Event (SAE)

Number of Participants with an Serious Adverse Event (SAE)

Time frame: 30 days

Number of Participants With an Adverse Event Leading to Discontinuation

Number of Participants with an Adverse Event Leading to Discontinuation

Time frame: 30 Days

Number of Participants With an Adverse Event Leading to Dose Modification

Number of Participants with an Adverse Event Leading to dose modification

Time frame: 30 Days

Number of Participants With Select Adverse Events

Number of Participants with select adverse events. Select Adverse events include: gastrointestinal, hepatic, hypersensitivity/infusion reaction, pulmonary, renal, or skin.

Time frame: 30 Days

Number of Participants With an Immune-mediated Adverse Event (IMAE)

Number of Participants with an immune-mediated adverse event (IMAE)

Time frame: 100 days

Time to Onset and Time to Resolution of Immune-related Adverse Events

Time to onset and time to resolution of immune-related adverse events

Time frame: 100 days

Number of Participants Who Experienced Death

Number of Participants who experienced death

Time frame: 100 days

Number of Participants With an Abnormality in Specific Thyroid Tests

Number of participants with an abnormality in specific thyroid tests

Time frame: 30 Days

Number of Participants With an Abnormality in Specific Liver Tests

Number of participants with an abnormality in specific liver tests

Time frame: 30 days