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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)

Primary Purpose

Head and Neck Cancer

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Nivolumab

Ipilimumab

Placebo

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 apply

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nivolumab and Ipilimumab

Nivolumab and Ipilimumab-placebo

Arm Description

Specified dose on specified days

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup

ORR is defined as best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup

The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.

Time to Response (TTR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup

Time to Response (TTR) for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Secondary Outcome Measures

Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup

ORR is defined as percentage of participants with a complete response (CR) or partial response (PR). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup

The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.

Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup

The time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup

the time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Overall Survival (OS)

Overall Survival (OS) - Platinum Refractory Subgroup

Overall Survival (OS) - Platinum Eligible Subgroup

ORR - Platinum Eligible Subgroup Based on HPV p-16 Status

ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

ORR - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Biomarker

ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

ORR - Platinum Refractory Subgroup Based on HPV p-16 Status

ORR - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Biomarker

Duration of Response (DOR) - Platinum Refractory Subgroup Based on HPV p-16 Status

The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.

Duration of Response (DOR) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status

Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on HPV p-16 Status

Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status

the time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first. Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Overall Survival (OS) - Platinum Refractory Subgroup Based on HPV p-16 Status

Overall Survival (OS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status

Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb

Overall Survival (OS) - Platinum Eligible Subgroup Based on HPV p-16 Status

Overall Survival (OS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status

Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status

Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on HPV p-16 Status

Duration of Response (DOR) - Platinum Eligible Subgroup Based on HPV p-16 Status

The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Duration of Response (DOR) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status

The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Duration of Response (DOR) - Platinum Refractory Subgroup Based on PD-L1 Status

The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

ORR - Platinum Refractory Subgroup Based on PD-L1 Expression

ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Overall Survival (OS) - Platinum Refractory Subgroup Based on PD-L1 Status

Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay

Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on PD-L1 Status

The time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Duration of Response (DOR) - Platinum Eligible Subgroup Based on PD-L1 Status

The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

ORR - Platinum Eligible Subgroup Based on PD-L1 Expression

ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Overall Survival (OS) - Platinum Eligible Subgroup Based on PD-L1 Status

Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay

Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on PD-L1 Status

The time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Full Information

NCT ID

NCT02823574

First Posted

July 1, 2016

Last Updated

April 28, 2023

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT02823574

Brief Title

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

Acronym

CheckMate 714

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)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

November 8, 2016 (Actual)

Primary Completion Date

January 23, 2019 (Actual)

Study Completion Date

April 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

425 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nivolumab and Ipilimumab

Arm Type

Experimental

Arm Description

Specified dose on specified days

Arm Title

Nivolumab and Ipilimumab-placebo

Arm Type

Active Comparator

Arm Description

Specified dose on specified days

Intervention Type

Biological

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

Opdivo

Intervention Type

Biological

Intervention Name(s)

Ipilimumab

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup

Description

Time Frame

Approximately up to 30 months (from FPFV to Data base lock)

Title

Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup

Description

The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.

Time Frame

Approximately up to 30 months (from FPFV to Data base lock)

Title

Time to Response (TTR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup

Description

Time Frame

Approximately up to 30 months (from FPFV to Data base lock)

Secondary Outcome Measure Information:

Title

Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup

Description

Time Frame

From randomization to end of study. Approximately 63 Months

Title

Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup

Description

The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.

Time Frame

From randomization to disease progression or death. Approximately 63 Months

Title

Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup

Description

Time Frame

From randomization to disease progression or death. Approximately 63 Months

Title

Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup

Description

Time Frame

From randomization to disease progression or death. Approximately 63 Months

Title

Overall Survival (OS)

Description

Time Frame

From randomization to death. Approximately 63 Months

Title

Overall Survival (OS) - Platinum Refractory Subgroup

Description

Time Frame

From randomization to death. Approximately 63 Months

Title

Overall Survival (OS) - Platinum Eligible Subgroup

Description

Time Frame

From randomization to death. Approximately 63 Months

Title

ORR - Platinum Eligible Subgroup Based on HPV p-16 Status

Description

Time Frame

From randomization to end of study. Approximately 63 Months

Title

ORR - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Biomarker

Description

Time Frame

From randomization to end of study. Approximately 63 Months

Title

ORR - Platinum Refractory Subgroup Based on HPV p-16 Status

Description

Time Frame

From randomization to end of study. Approximately 63 Months

Title

ORR - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Biomarker

Description

Time Frame

From randomization to end of study. Approximately 63 Months

Title

Duration of Response (DOR) - Platinum Refractory Subgroup Based on HPV p-16 Status

Description

The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.

Time Frame

From randomization to disease progression or death. Approximately 63 Months

Title

Duration of Response (DOR) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status

Description

Time Frame

From randomization to disease progression or death. Approximately 63 Months

Title

Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on HPV p-16 Status

Description

Time Frame

From randomization to disease progression or death. Approximately 63 Months

Title

Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status

Description

Time Frame

From randomization to disease progression or death. Approximately 63 Months

Title

Overall Survival (OS) - Platinum Refractory Subgroup Based on HPV p-16 Status

Description

Time Frame

From randomization to death. Approximately 63 Months

Title

Overall Survival (OS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status

Description

Time Frame

From randomization to death. Approximately 63 Months

Title

Overall Survival (OS) - Platinum Eligible Subgroup Based on HPV p-16 Status

Description

Time Frame

From randomization to death. Approximately 63 Months

Title

Overall Survival (OS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status

Description

Time Frame

From randomization to death. Approximately 63 Months

Title

Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status

Description

Time Frame

From randomization to disease progression or death. Approximately 63 Months

Title

Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on HPV p-16 Status

Description

Time Frame

From randomization to disease progression or death. Approximately 63 Months

Title

Duration of Response (DOR) - Platinum Eligible Subgroup Based on HPV p-16 Status

Description

Time Frame

From randomization to disease progression or death. Approximately 63 Months

Title

Duration of Response (DOR) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status

Description

Time Frame

From randomization to disease progression or death. Approximately 63 Months

Title

Duration of Response (DOR) - Platinum Refractory Subgroup Based on PD-L1 Status

Description

Time Frame

From randomization to disease progression or death. Approximately 63 Months

Title

ORR - Platinum Refractory Subgroup Based on PD-L1 Expression

Description

ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Time Frame

From randomization to end of study. Approximately 63 Months

Title

Overall Survival (OS) - Platinum Refractory Subgroup Based on PD-L1 Status

Description

Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay

Time Frame

From randomization to death. Approximately 63 Months

Title

Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on PD-L1 Status

Description

Time Frame

From randomization to disease progression or death. Approximately 63 Months

Title

Duration of Response (DOR) - Platinum Eligible Subgroup Based on PD-L1 Status

Description

The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Time Frame

From randomization to disease progression or death. Approximately 63 Months

Title

ORR - Platinum Eligible Subgroup Based on PD-L1 Expression

Description

ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Time Frame

From randomization to end of study. Approximately 63 Months

Title

Overall Survival (OS) - Platinum Eligible Subgroup Based on PD-L1 Status

Description

Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay

Time Frame

From randomization to death. Approximately 63 Months

Title

Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on PD-L1 Status

Description

The time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first. Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Time Frame

From randomization to disease progression or death. Approximately 63 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

University of Arizona Cancer Center

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724-5024

Country

United States

Facility Name

Local Institution - 0034

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Facility Name

Los Angeles Cancer Network

City

Los Angeles

State/Province

California

ZIP/Postal Code

90017

Country

United States

Facility Name

Ucla Department Of Medicine

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Local Institution - 0098

City

Redondo Beach

State/Province

California

ZIP/Postal Code

90277

Country

United States

Facility Name

Local Institution - 0004

City

Sacramento

State/Province

California

ZIP/Postal Code

95816

Country

United States

Facility Name

Local Institution - 0072

City

San Francisco

State/Province

California

ZIP/Postal Code

94158

Country

United States

Facility Name

Local Institution - 0097

City

San Luis Obispo

State/Province

California

ZIP/Postal Code

93401

Country

United States

Facility Name

Central Coast Med Oncology

City

Santa Maria

State/Province

California

ZIP/Postal Code

93454

Country

United States

Facility Name

Local Institution - 0101

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Facility Name

Local Institution - 0007

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Local Institution - 0010

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Local Institution - 0015

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

Local Institution - 0087

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Ft. Wayne Med Onco-Hema Inc

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46845

Country

United States

Facility Name

Local Institution - 0005

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Oncology Associated Of Western Kentucky

City

Paducah

State/Province

Kentucky

ZIP/Postal Code

42003

Country

United States

Facility Name

Local Institution - 0001

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Local Institution - 0071

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Local Institution - 0042

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Mission Hospital, Inc

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28801

Country

United States

Facility Name

Local Institution - 0103

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Local Institution - 0070

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Local Institution - 0008

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Local Institution - 0006

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Facility Name

Donald Guthrie Foundation

City

Sayre

State/Province

Pennsylvania

ZIP/Postal Code

18840

Country

United States

Facility Name

Local Institution - 0102

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

Local Institution - 0038

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

Local Institution - 0121

City

Pergamino

State/Province

Buenos Aires

ZIP/Postal Code

Country

Argentina

Facility Name

Local Institution - 0111

City

Buenos Aires

ZIP/Postal Code

C1181ACH

Country

Argentina

Facility Name

Local Institution - 0023

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Local Institution - 0074

City

Sint-Niklaas

ZIP/Postal Code

9100

Country

Belgium

Facility Name

Local Institution - 0053

City

Yvoir

ZIP/Postal Code

5530

Country

Belgium

Facility Name

Local Institution - 0046

City

Belo Horizonte

State/Province

Minas Gerais

ZIP/Postal Code

30130-090

Country

Brazil

Facility Name

Local Institution - 0124

City

Ipatinga

State/Province

Minas Gerais

ZIP/Postal Code

35160-158

Country

Brazil

Facility Name

Local Institution - 0047

City

Curitiba

State/Province

Parana

ZIP/Postal Code

81480-580

Country

Brazil

Facility Name

Local Institution - 0125

City

Caxias do Sul

State/Province

RIO Grande DO SUL

ZIP/Postal Code

95070-560

Country

Brazil

Facility Name

Local Institution - 0051

City

Ijui

State/Province

RIO Grande DO SUL

ZIP/Postal Code

98700-000

Country

Brazil

Facility Name

Local Institution - 0052

City

Porto Alegre

State/Province

RIO Grande DO SUL

ZIP/Postal Code

90035-903

Country

Brazil

Facility Name

Local Institution - 0045

City

Barretos

State/Province

Sao Paulo

ZIP/Postal Code

14784-400

Country

Brazil

Facility Name

Local Institution - 0123

City

Santo Andre

State/Province

Sao Paulo

ZIP/Postal Code

09060-870

Country

Brazil

Facility Name

Local Institution - 0048

City

Sao Jose do Rio Preto

State/Province

SAO Paulo

ZIP/Postal Code

15090-000

Country

Brazil

Facility Name

Local Institution

City

Rio de Janeiro

ZIP/Postal Code

20231-050

Country

Brazil

Facility Name

Local Institution - 0049

City

Sao Paulo

ZIP/Postal Code

04039-004

Country

Brazil

Facility Name

Local Institution - 0050

City

Sao Paulo

ZIP/Postal Code

05403-010

Country

Brazil

Facility Name

Local Institution - 0013

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

Local Institution - 0056

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

Local Institution - 0012

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1Z5

Country

Canada

Facility Name

Local Institution - 0016

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2X 3E4

Country

Canada

Facility Name

Local Institution - 0014

City

Quebec

ZIP/Postal Code

G1J 1Z4

Country

Canada

Facility Name

Local Institution - 0115

City

Santiago

State/Province

Metropolitana

Country

Chile

Facility Name

Local Institution - 0022

City

Brno

ZIP/Postal Code

656 53

Country

Czechia

Facility Name

Local Institution - 0020

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Local Institution - 0021

City

Olomouc

ZIP/Postal Code

779 00

Country

Czechia

Facility Name

Local Institution - 0069

City

Helsinki

ZIP/Postal Code

00290

Country

Finland

Facility Name

Local Institution - 0032

City

Amiens Cedex 1

ZIP/Postal Code

80054

Country

France

Facility Name

Local Institution - 0120

City

Bordeaux

ZIP/Postal Code

33075

Country

France

Facility Name

Local Institution - 0073

City

Clermont Ferrand cedex 01

ZIP/Postal Code

63011

Country

France

Facility Name

Local Institution - 0089

City

Clichy

ZIP/Postal Code

92110

Country

France

Facility Name

Local Institution - 0029

City

Lyon Cedex 08

ZIP/Postal Code

69373

Country

France

Facility Name

Local Institution - 0075

City

Marseille Cedex 5

ZIP/Postal Code

13385

Country

France

Facility Name

Local Institution - 0079

City

Nice

ZIP/Postal Code

06189

Country

France

Facility Name

Local Institution - 0030

City

Rennes Cedex

ZIP/Postal Code

35042

Country

France

Facility Name

Local Institution - 0088

City

Villejuif

ZIP/Postal Code

94805

Country

France

Facility Name

Local Institution - 0026

City

Dublin 8

State/Province

Dublin

Country

Ireland

Facility Name

Local Institution

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

Local Institution - 0119

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Local Institution - 0090

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97070

Country

Mexico

Facility Name

Local Institution - 0107

City

Merida

State/Province

Yucatan

ZIP/Postal Code

97138

Country

Mexico

Facility Name

Local Institution - 0108

City

Oaxaca

ZIP/Postal Code

68040

Country

Mexico

Facility Name

Local Institution - 0068

City

Amsterdam

ZIP/Postal Code

1066 CX

Country

Netherlands

Facility Name

Local Institution - 0028

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

Local Institution - 0027

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

Local Institution - 0065

City

Bergen

ZIP/Postal Code

5021

Country

Norway

Facility Name

Local Institution - 0064

City

Oslo

ZIP/Postal Code

0379

Country

Norway

Facility Name

Local Institution - 0055

City

Bucharest

ZIP/Postal Code

010991

Country

Romania

Facility Name

Local Institution - 0054

City

Cluj-Napoca

ZIP/Postal Code

400015

Country

Romania

Facility Name

Local Institution - 0033

City

Craiova

ZIP/Postal Code

200347

Country

Romania

Facility Name

Local Institution - 0060

City

Iasi

ZIP/Postal Code

700483

Country

Romania

Facility Name

Local Institution - 0059

City

Suceava

ZIP/Postal Code

720237

Country

Romania

Facility Name

Local Institution - 0031

City

Moscow

ZIP/Postal Code

121309

Country

Russian Federation

Facility Name

Local Institution - 0092

City

Ryazan

ZIP/Postal Code

390011

Country

Russian Federation

Facility Name

Local Institution

City

Port Elizabeth

State/Province

Eastern Cape

ZIP/Postal Code

6045

Country

South Africa

Facility Name

Local Institution

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0084

Country

South Africa

Facility Name

Local Institution - 0017

City

Sandton

State/Province

Gauteng

ZIP/Postal Code

2199

Country

South Africa

Facility Name

Local Institution

City

Cape Town

State/Province

Western CAPE

ZIP/Postal Code

7700

Country

South Africa

Facility Name

Local Institution - 0040

City

A Coruna

ZIP/Postal Code

15009

Country

Spain

Facility Name

Local Institution - 0116

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Local Institution - 0039

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Local Institution - 0077

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Local Institution - 0076

City

Marbella

ZIP/Postal Code

29603

Country

Spain

Facility Name

Local Institution - 0041

City

San Sabastian Gipuzkoa

ZIP/Postal Code

20014

Country

Spain

Facility Name

Local Institution - 0067

City

Goteborg

ZIP/Postal Code

413 45

Country

Sweden

Facility Name

Local Institution - 0037

City

Lund

ZIP/Postal Code

221 85

Country

Sweden

Facility Name

Local Institution - 0035

City

Stockholm

ZIP/Postal Code

171 76

Country

Sweden

Facility Name

Local Institution - 0063

City

Adana

ZIP/Postal Code

01250

Country

Turkey

Facility Name

Local Institution - 0066

City

Antalya

ZIP/Postal Code

07070

Country

Turkey

Facility Name

Local Institution - 0062

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Local Institution - 0110

City

Aberdeen

State/Province

Aberdeenshire

ZIP/Postal Code

AB25 2ZN

Country

United Kingdom

Facility Name

Local Institution - 0086

City

London

State/Province

Greater London

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Facility Name

Local Institution - 0083

City

Wirral

State/Province

Merseyside

ZIP/Postal Code

L63 4JY

Country

United Kingdom

Facility Name

Local Institution - 0081

City

Sutton

State/Province

Surrey

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Facility Name

Local Institution - 0114

City

Cardiff

ZIP/Postal Code

CF14 2TL

Country

United Kingdom

Facility Name

Local Institution - 0084

City

Glasgow

ZIP/Postal Code

G12 0YN

Country

United Kingdom

Facility Name

Local Institution - 0082

City

Newcastle Upon Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

12. IPD Sharing Statement

Links:

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

BMS Clinical Trial Information

URL

https://www.bmsstudyconnect.com/s/US/English/USenHome

Description

BMS Clinical Trial Patient Recruiting

URL

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

Description

FDA Safety Alerts and Recalls

Learn more about this trial

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

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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)

Head and Neck Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial