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Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (CheckMate 714)

This study is currently recruiting participants.
Verified September 2017 by Bristol-Myers Squibb
Sponsor:
ClinicalTrials.gov Identifier:
NCT02823574
First Posted: July 6, 2016
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
A study in patients with metastatic or recurrent squamous cell cancer of the head and neck to evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate 714)

Condition Intervention Phase
Head and Neck Cancer Biological: Nivolumab Biological: Ipilimumab Other: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Two Arm Phase 2 Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Overall response rate (ORR) in platinum refractory subgroup [ Time Frame: 19 months ]

    Subjects that are platinum refractory are defined as:

    • squamous cell cancer of the head and neck
    • recurrence < 6 months after completion of previous platinum based chemotherapy
    • no prior therapy for recurrent or metastatic disease

  • Duration of Response (DOR) in platinum refractory subgroup [ Time Frame: 19 months ]

    Subjects that are platinum refractory are defined as:

    • squamous cell cancer of the head and neck
    • recurrence < 6 months after completion of previous platinum based chemotherapy
    • no prior therapy for recurrent or metastatic disease


Secondary Outcome Measures:
  • ORR in platinum eligible subgroup [ Time Frame: 19 months ]

    Subjects that are platinum eligible are defined as:

    • squamous cell cancer of the head and neck
    • recurrence ≥6 months after completion of previous platinum based chemotherapy
    • no prior therapy for recurrent or metastatic disease

  • Progression Free Survival (PFS) in platinum eligible and refractory subgroups [ Time Frame: 19 months ]
  • Overall Survival (OS) in platinum eligible and refractory subgroups [ Time Frame: 19 months ]
  • DOR in platinum eligible subgroup [ Time Frame: 19 months ]

    Subjects that are platinum eligible are defined as:

    • squamous cell cancer of the head and neck
    • recurrence ≥6 months after completion of previous platinum based chemotherapy
    • no prior therapy for recurrent or metastatic disease


Estimated Enrollment: 400
Actual Study Start Date: September 22, 2016
Estimated Study Completion Date: October 17, 2020
Estimated Primary Completion Date: May 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nivolumab and Ipilimumab
Specified dose on specified days
Biological: Nivolumab Biological: Ipilimumab
Active Comparator: Nivolumab and Ipilimumab-placebo
Specified dose on specified days
Biological: Nivolumab Other: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Confirmed squamous cell head and neck cancer
  • Widespread (metastatic) disease, or returned after previous treatment (recurrent)
  • Tumor sample must be available for analysis of PDL1 (Programmed death-ligand 1) and HPV [Human Papilloma Virus (oropharynx only)]
  • Performance status ECOG 0-1 (Eastern Cooperative Oncology Group)

Exclusion Criteria:

  • Previous treatment for metastatic or recurrent disease
  • Cancer arising from one of the following primary sites: paranasal sinus, nasopharynx, salivary gland, skin
  • Any non-squamous subtype
  • Active autoimmune disease
  • Positive test for hepatitis B, C or HIV (Human Immunodeficiency Virus) virus
  • Previous treatment with checkpoint inhibitor drugs
  • Active CNS metastases or carcinomatous meningitis

Other protocol defined inclusion/exclusion criteria could apply

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02823574


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 111 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02823574     History of Changes
Other Study ID Numbers: CA209-714
2016-001645-64 ( EudraCT Number )
First Submitted: July 1, 2016
First Posted: July 6, 2016
Last Update Posted: October 2, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs