Head and Neck CancerPhase 2CheckMate 714NCT02823574
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
A Phase 2 study testing Nivolumab and Ipilimumab in people with Head and Neck Cancer, run by Bristol-Myers Squibb at 105 sites in 21 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Nivolumab and Ipilimumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 425 participants
- Where
- 105 sitesin 21 countries
- Study dates
- 8 Nov 2016to 21 Apr 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
105 sites in 21 countries.
105 sites in 21 countries
United States28 sites
Mission Hospital, Inc
Asheville, North Carolina, 28801
Local Institution - 0010
Atlanta, Georgia, 30322
Local Institution - 0001
Boston, Massachusetts, 02215
Local Institution - 0071
Boston, Massachusetts, 02215
Local Institution - 0087
Chicago, Illinois, 60637
Local Institution - 0103
Cincinnati, Ohio, 45219
Local Institution - 0070
Cleveland, Ohio, 44106
Local Institution - 0102
Dallas, Texas, 75390
Local Institution - 0015
Decatur, Georgia, 30033
Local Institution - 0034
Duarte, California, 91010
Ft. Wayne Med Onco-Hema Inc
Fort Wayne, Indiana, 46845
Los Angeles Cancer Network
Los Angeles, California, 90017
Ucla Department Of Medicine
Los Angeles, California, 90095
Local Institution - 0005
Louisville, Kentucky, 40202
Local Institution - 0101
New Haven, Connecticut, 06520
Oncology Associated Of Western Kentucky
Paducah, Kentucky, 42003
Local Institution - 0006
Pittsburgh, Pennsylvania, 15232
Local Institution - 0008
Portland, Oregon, 97239
Local Institution - 0098
Redondo Beach, California, 90277
Local Institution - 0042
Rochester, Minnesota, 55905
Local Institution - 0004
Sacramento, California, 95816
Local Institution - 0072
San Francisco, California, 94158
Local Institution - 0097
San Luis Obispo, California, 93401
Central Coast Med Oncology
Santa Maria, California, 93454
Donald Guthrie Foundation
Sayre, Pennsylvania, 18840
Local Institution - 0038
Seattle, Washington, 98109
Local Institution - 0007
Tampa, Florida, 33612
University of Arizona Cancer Center
Tucson, Arizona, 85724-5024
Brazil12 sites
Local Institution - 0045
Barretos, São Paulo, 14784-400
Local Institution - 0046
Belo Horizonte, Minas Gerais, 30130-090
Local Institution - 0125
Caxias do Sul, Rio Grande do Sul, 95070-560
Local Institution - 0047
Curitiba, Paraná, 81480-580
Local Institution - 0051
Ijuí, Rio Grande do Sul, 98700-000
Local Institution - 0124
Ipatinga, Minas Gerais, 35160-158
Local Institution - 0052
Porto Alegre, Rio Grande do Sul, 90035-903
Local Institution
Rio de Janeiro, 20231-050
Local Institution - 0123
Santo André, São Paulo, 09060-870
Local Institution - 0048
São José do Rio Preto, São Paulo, 15090-000
Local Institution - 0049
São Paulo, 04039-004
Local Institution - 0050
São Paulo, 05403-010
France9 sites
Local Institution - 0032
Amiens, 80054
Local Institution - 0120
Bordeaux, 33075
Local Institution - 0073
Clermont-Ferrand, 63011
Local Institution - 0089
Clichy, 92110
Local Institution - 0029
Lyon, 69373
Local Institution - 0075
Marseille, 13385
Local Institution - 0079
Nice, 06189
Local Institution - 0030
Rennes, 35042
Local Institution - 0088
Villejuif, 94805
United Kingdom7 sites
Local Institution - 0110
Aberdeen, Aberdeenshire, AB25 2ZN
Local Institution - 0114
Cardiff, CF14 2TL
Local Institution - 0084
Glasgow, G12 0YN
Local Institution - 0086
London, Greater London, SW3 6JJ
Local Institution - 0083
Metropolitan Borough of Wirral, Merseyside, L63 4JY
Local Institution - 0082
Newcastle upon Tyne, NE7 7DN
Local Institution - 0081
Sutton, Surrey, SM2 5PT
Spain6 sites
Local Institution - 0040
A Coruña, 15009
Local Institution - 0116
Barcelona, 08035
Local Institution - 0039
Barcelona, 08036
Local Institution - 0077
Madrid, 28041
Local Institution - 0076
Marbella, 29603
Local Institution - 0041
San Sabastian Gipuzkoa, 20014
Canada5 sites
Local Institution - 0013
Edmonton, Alberta, T6G 1Z2
Local Institution - 0016
Montreal, Quebec, H2X 3E4
Local Institution - 0056
Ottawa, Ontario, K1H 8L6
Local Institution - 0014
Québec, Quebec, G1J 1Z4
Local Institution - 0012
Toronto, Ontario, M5G 1Z5
Romania5 sites
Local Institution - 0055
Bucharest, 010991
Local Institution - 0054
Cluj-Napoca, 400015
Local Institution - 0033
Craiova, 200347
Local Institution - 0060
Iași, 700483
Local Institution - 0059
Suceava, 720237
South Africa4 sites
Local Institution
Cape Town, Western Cape, 7700
Local Institution
Port Elizabeth, Eastern Cape, 6045
Local Institution
Pretoria, Gauteng, 0084
Local Institution - 0017
Sandton, Gauteng, 2199
Belgium3 sites
Local Institution - 0023
Ghent, 9000
Local Institution - 0074
Sint-Niklaas, 9100
Local Institution - 0053
Yvoir, 5530
Czechia3 sites
Local Institution - 0022
Brno, 656 53
Local Institution - 0020
Hradec Králové, 500 05
Local Institution - 0021
Olomouc, 779 00
Mexico3 sites
Local Institution - 0090
Mérida, Yucatán, 97070
Local Institution - 0107
Mérida, Yucatán, 97138
Local Institution - 0108
Oaxaca City, 68040
Netherlands3 sites
Local Institution - 0068
Amsterdam, 1066 CX
Local Institution - 0028
Amsterdam, 1081 HV
Local Institution - 0027
Groningen, 9713 GZ
Sweden3 sites
Local Institution - 0067
Gothenburg, 413 45
Local Institution - 0037
Lund, 221 85
Local Institution - 0035
Stockholm, 171 76
Turkey (Türkiye)3 sites
Local Institution - 0063
Adana, 01250
Local Institution - 0066
Antalya, 07070
Local Institution - 0062
Izmir, 35340
Argentina2 sites
Local Institution - 0111
Buenos Aires, C1181ACH
Local Institution - 0121
Pergamino, Buenos Aires, 0
Italy2 sites
Local Institution
Milan, 20133
Local Institution - 0119
Naples, 80131
Norway2 sites
Local Institution - 0065
Bergen, 5021
Local Institution - 0064
Oslo, 0379
Russia2 sites
Local Institution - 0031
Moscow, 121309
Local Institution - 0092
Ryazan, 390011
About this study
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)
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)
- Conditions
- Head and Neck Cancer
- Being tested
- Nivolumab, Ipilimumab, Placebo
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabBiological
Also called Opdivo
IpilimumabBiological
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab and Ipilimumab | Experimental | Specified dose on specified days Receives: Biological: Nivolumab; Biological: Ipilimumab |
| Nivolumab and Ipilimumab-placebo | Active comparator | Specified dose on specified days Receives: Biological: Nivolumab; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately up to 30 months (from FPFV to Data base lock)
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.
Measured: Approximately up to 30 months (from FPFV to Data base lock)
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.
Measured: Approximately up to 30 months (from FPFV to Data base lock)
Secondary outcomes (31)
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.
Measured: From randomization to end of study. Approximately 63 Months
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.
Measured: From randomization to disease progression or death. Approximately 63 Months
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).
Measured: From randomization to disease progression or death. Approximately 63 Months
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).
Measured: From randomization to disease progression or death. Approximately 63 Months
Overall Survival (OS)
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.
Measured: From randomization to death. Approximately 63 Months
Overall Survival (OS) - Platinum Refractory Subgroup
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.
Measured: From randomization to death. Approximately 63 Months
Overall Survival (OS) - Platinum Eligible Subgroup
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.
Measured: From randomization to death. Approximately 63 Months
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.
Measured: From randomization to end of study. Approximately 63 Months
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.
Measured: From randomization to end of study. Approximately 63 Months
ORR - Platinum Refractory 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.
Measured: From randomization to end of study. Approximately 63 Months
ORR - Platinum Refractory 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.
Measured: From randomization to end of study. Approximately 63 Months
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.
Measured: From randomization to disease progression or death. Approximately 63 Months
Duration of Response (DOR) - Platinum Refractory 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
Measured: From randomization to disease progression or death. Approximately 63 Months
Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on HPV p-16 Status
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).
Measured: From randomization to disease progression or death. Approximately 63 Months
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).
Measured: From randomization to disease progression or death. Approximately 63 Months
Overall Survival (OS) - Platinum Refractory Subgroup Based on HPV p-16 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.
Measured: From randomization to death. Approximately 63 Months
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
Measured: From randomization to death. Approximately 63 Months
Overall Survival (OS) - Platinum Eligible Subgroup Based on HPV p-16 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.
Measured: From randomization to death. Approximately 63 Months
Overall Survival (OS) - Platinum Eligible 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
Measured: From randomization to death. Approximately 63 Months
Progression Free Survival (PFS) - Platinum Eligible 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).
Measured: From randomization to disease progression or death. Approximately 63 Months
Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on HPV p-16 Status
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).
Measured: From randomization to disease progression or death. Approximately 63 Months
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).
Measured: From randomization to disease progression or death. Approximately 63 Months
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).
Measured: From randomization to disease progression or death. Approximately 63 Months
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).
Measured: From randomization to disease progression or death. Approximately 63 Months
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.
Measured: From randomization to end of study. Approximately 63 Months
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
Measured: From randomization to death. Approximately 63 Months
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).
Measured: From randomization to disease progression or death. Approximately 63 Months
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).
Measured: From randomization to disease progression or death. Approximately 63 Months
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.
Measured: From randomization to end of study. Approximately 63 Months
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
Measured: From randomization to death. Approximately 63 Months
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).
Measured: From randomization to disease progression or death. Approximately 63 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study start8 Nov 2016
- Primary completion23 Jan 2019
- Study completion21 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823574
- Sponsor's protocol ID
- CA209-714
- Other IDs
- 2016-001645-64, 2016
- Acronym
- CheckMate 714
- Status last verified
- Apr 2023
- First submitted
- 1 Jul 2016
- Last updated
- 3 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Expanded access
- Available
Publications
Harrington KJ, Ferris RL, Gillison M, Tahara M, Argiris A, Fayette J, Schenker M, Bratland A, Walker JWT, Grell P, Even C, Chung CH, Redman R, Coutte A, Salas S, Grant C, de Azevedo S, Soulieres D, Hansen AR, Wei L, Khan TA, Miller-Moslin K, Roberts M, Haddad R. Efficacy and Safety of Nivolumab Plus Ipilimumab vs Nivolumab Alone for Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: The Phase 2 CheckMate 714 Randomized Clinical Trial. JAMA Oncol. 2023 Jun 1;9(6):779-789. doi: 10.1001/jamaoncol.2023.0147.
PubMed 37022706
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02823574
- Acronym / sponsor ID
- CheckMate 714 / CA209-714
- Conditions
- Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2016 (actual)
- Primary completion
- 23 Jan 2019 (actual)
- Study completion
- 21 Apr 2022 (actual)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Posted 21 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nivolumab and Ipilimumab | Experimental | Biological: Nivolumab, Biological: IpilimumabSpecified dose on specified days |
| Nivolumab and Ipilimumab-placebo | Active comparator | Biological: Nivolumab, Other: PlaceboSpecified dose on specified days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: Opdivo | Biological | Nivolumab and Ipilimumab, Nivolumab and Ipilimumab-placebo |
| Ipilimumab | Biological | Nivolumab and Ipilimumab |
| Placebo | Other | Nivolumab and Ipilimumab-placebo |
Primary outcome
Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup
Time frame: Approximately up to 30 months (from FPFV to Data base lock)
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
Time frame: Approximately up to 30 months (from FPFV to Data base lock)
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 frame: Approximately up to 30 months (from FPFV to Data base lock)
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.
31 secondary outcomes
Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup
Time frame: From randomization to end of study. Approximately 63 Months
Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup
Time frame: From randomization to disease progression or death. Approximately 63 Months
Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup
Time frame: From randomization to disease progression or death. Approximately 63 Months
Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup
Time frame: From randomization to disease progression or death. Approximately 63 Months
Overall Survival (OS)
Time frame: From randomization to death. Approximately 63 Months
Overall Survival (OS) - Platinum Refractory Subgroup
Time frame: From randomization to death. Approximately 63 Months
Overall Survival (OS) - Platinum Eligible Subgroup
Time frame: From randomization to death. Approximately 63 Months
ORR - Platinum Eligible Subgroup Based on HPV p-16 Status
Time frame: From randomization to end of study. Approximately 63 Months
ORR - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Biomarker
Time frame: From randomization to end of study. Approximately 63 Months
ORR - Platinum Refractory Subgroup Based on HPV p-16 Status
Time frame: From randomization to end of study. Approximately 63 Months
ORR - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Biomarker
Time frame: From randomization to end of study. Approximately 63 Months
Duration of Response (DOR) - Platinum Refractory Subgroup Based on HPV p-16 Status
Time frame: From randomization to disease progression or death. Approximately 63 Months
Duration of Response (DOR) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status
Time frame: From randomization to disease progression or death. Approximately 63 Months
Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on HPV p-16 Status
Time frame: From randomization to disease progression or death. Approximately 63 Months
Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status
Time frame: From randomization to disease progression or death. Approximately 63 Months
Overall Survival (OS) - Platinum Refractory Subgroup Based on HPV p-16 Status
Time frame: From randomization to death. Approximately 63 Months
Overall Survival (OS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status
Time frame: From randomization to death. Approximately 63 Months
Overall Survival (OS) - Platinum Eligible Subgroup Based on HPV p-16 Status
Time frame: From randomization to death. Approximately 63 Months
Overall Survival (OS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status
Time frame: From randomization to death. Approximately 63 Months
Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status
Time frame: From randomization to disease progression or death. Approximately 63 Months
Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on HPV p-16 Status
Time frame: From randomization to disease progression or death. Approximately 63 Months
Duration of Response (DOR) - Platinum Eligible Subgroup Based on HPV p-16 Status
Time frame: From randomization to disease progression or death. Approximately 63 Months
Duration of Response (DOR) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status
Time frame: From randomization to disease progression or death. Approximately 63 Months
Duration of Response (DOR) - Platinum Refractory Subgroup Based on PD-L1 Status
Time frame: From randomization to disease progression or death. Approximately 63 Months
ORR - Platinum Refractory Subgroup Based on PD-L1 Expression
Time frame: From randomization to end of study. Approximately 63 Months
Overall Survival (OS) - Platinum Refractory Subgroup Based on PD-L1 Status
Time frame: From randomization to death. Approximately 63 Months
Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on PD-L1 Status
Time frame: From randomization to disease progression or death. Approximately 63 Months
Duration of Response (DOR) - Platinum Eligible Subgroup Based on PD-L1 Status
Time frame: From randomization to disease progression or death. Approximately 63 Months
ORR - Platinum Eligible Subgroup Based on PD-L1 Expression
Time frame: From randomization to end of study. Approximately 63 Months
Overall Survival (OS) - Platinum Eligible Subgroup Based on PD-L1 Status
Time frame: From randomization to death. Approximately 63 Months
Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on PD-L1 Status
Time frame: From randomization to disease progression or death. Approximately 63 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37022706Harrington KJ, Ferris RL, Gillison M, Tahara M, Argiris A, Fayette J, Schenker M, Bratland A, Walker JWT, Grell P, Even C, Chung CH, Redman R, Coutte A, Salas S, Grant C, de Azevedo S, Soulieres D, Hansen AR, Wei L, Khan TA, Miller-Moslin K, Roberts M, Haddad R. Efficacy and Safety of Nivolumab Plus Ipilimumab vs Nivolumab Alone for Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: The Phase 2 CheckMate 714 Randomized Clinical Trial. JAMA Oncol. 2023 Jun 1;9(6):779-789. doi: 10.1001/jamaoncol.2023.0147.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
105 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab and Ipilimumab in people with Head and Neck Cancer, run by Bristol-Myers Squibb at 105 sites in 21 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 105 sites in United States, Brazil, France, United Kingdom, Spain and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup (time frame: Approximately up to 30 months (from FPFV to Data base lock)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02823574, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.