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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)

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ClinicalTrials.gov Identifier: NCT02823574
Recruitment Status : Active, not recruiting
First Posted : July 6, 2016
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Head and Neck Cancer Biological: Nivolumab Biological: Ipilimumab Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
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)
Actual Study Start Date : September 22, 2016
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : January 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Nivolumab and Ipilimumab
Specified dose on specified days
 Biological: Nivolumab
Other Name: Opdivo

Biological: Ipilimumab
Active Comparator: Nivolumab and Ipilimumab-placebo
Specified dose on specified days
 Biological: Nivolumab
Other Name: Opdivo

Other: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Overall response rate (ORR) in platinum refractory subgroup [ Time Frame: 28 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

  2. Duration of Response (DOR) in platinum refractory subgroup [ Time Frame: 28 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 :
  1. ORR in platinum eligible subgroup [ Time Frame: 28 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

  2. Progression Free Survival (PFS) in platinum eligible and refractory subgroups [ Time Frame: 28 months ]
  3. Overall Survival (OS) in platinum eligible and refractory subgroups [ Time Frame: 28 months ]
  4. DOR in platinum eligible subgroup [ Time Frame: 28 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

  5. Tumor mutation burden (TMB) in platinum eligible and refractory subgroups [ Time Frame: 28 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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


  Show 105 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS Clinical Trial Patient Recruiting  This link exits the ClinicalTrials.gov site
Investigator Inquiry Form  This link exits the ClinicalTrials.gov site
FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02823574     History of Changes
Other Study ID Numbers: CA209-714
2016-001645-64 ( EudraCT Number )
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

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