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Completed

NCT Number: NCT03349710

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

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

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Key information

Conditions

Squamous Cell Carcinoma of the Head and Neck Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Grenoble, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab

Biological

Specified dose on specified day

Other names: BMS-936558, Opdivo

Cetuximab

Drug

Specified dose on specified day

Other names: Erbitux

Cisplatin

Drug

Specified dose on specified day

Radiotherapy

Radiation

Specified dose on specified day

Primary outcomes

  1. Number of Participants With an Adverse Event (AE)

    Time frame: 30 Days

    Number of Participants with an Adverse Event

  2. Number of Participants With an Serious Adverse Event (SAE)

    Time frame: 30 days

    Number of Participants with an Serious Adverse Event (SAE)

  3. Number of Participants With an Adverse Event Leading to Discontinuation

    Time frame: 30 Days

    Number of Participants with an Adverse Event Leading to Discontinuation

  4. 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

  5. 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.

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

    Time frame: 100 days

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

  7. 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

  8. Number of Participants Who Experienced Death

    Time frame: 100 days

    Number of Participants who experienced death

  9. Number of Participants With an Abnormality in Specific Thyroid Tests

    Time frame: 30 Days

    Number of participants with an abnormality in specific thyroid tests

  10. Number of Participants With an Abnormality in Specific Liver Tests

    Time frame: 30 days

    Number of participants with an abnormality in specific liver tests

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Ono Pharmaceutical Co., Ltd.

Registry information

Official study 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)

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 21, 2017
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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