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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:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02823574
First received: July 1, 2016
Last updated: September 6, 2017
Last verified: September 2017
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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: | February 25, 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| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02823574
Show 108 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 108 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 ) |
| Study First Received: | July 1, 2016 |
| Last Updated: | September 6, 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 |
ClinicalTrials.gov processed this record on September 21, 2017