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

Head and Neck Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02823574
• Other study ID #: CA209-714
• Secondary ID: 2016-001645-64
• Status: Completed
• Phase: Phase 2
• Start date: November 8, 2016
• Est. completion date: April 21, 2022

Study information

• Verified date: April 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 425
• Est. completion date: April 21, 2022
• Est. primary completion date: January 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Squamous Cell Carcinoma of Head and Neck

Intervention

Biological:
• Nivolumab

• Ipilimumab

Other:
• Placebo

Locations

Country	Name	City	State
Argentina	Local Institution - 0111	Buenos Aires
Argentina	Local Institution - 0121	Pergamino	Buenos Aires
Belgium	Local Institution - 0023	Gent
Belgium	Local Institution - 0074	Sint-Niklaas
Belgium	Local Institution - 0053	Yvoir
Brazil	Local Institution - 0045	Barretos	Sao Paulo
Brazil	Local Institution - 0046	Belo Horizonte	Minas Gerais
Brazil	Local Institution - 0125	Caxias do Sul	RIO Grande DO SUL
Brazil	Local Institution - 0047	Curitiba	Parana
Brazil	Local Institution - 0051	Ijui	RIO Grande DO SUL
Brazil	Local Institution - 0124	Ipatinga	Minas Gerais
Brazil	Local Institution - 0052	Porto Alegre	RIO Grande DO SUL
Brazil	Local Institution	Rio de Janeiro
Brazil	Local Institution - 0123	Santo Andre	Sao Paulo
Brazil	Local Institution - 0048	Sao Jose do Rio Preto	SAO Paulo
Brazil	Local Institution - 0049	Sao Paulo
Brazil	Local Institution - 0050	Sao Paulo
Canada	Local Institution - 0013	Edmonton	Alberta
Canada	Local Institution - 0016	Montreal	Quebec
Canada	Local Institution - 0056	Ottawa	Ontario
Canada	Local Institution - 0014	Quebec
Canada	Local Institution - 0012	Toronto	Ontario
Chile	Local Institution - 0115	Santiago	Metropolitana
Czechia	Local Institution - 0022	Brno
Czechia	Local Institution - 0020	Hradec Kralove
Czechia	Local Institution - 0021	Olomouc
Finland	Local Institution - 0069	Helsinki
France	Local Institution - 0032	Amiens Cedex 1
France	Local Institution - 0120	Bordeaux
France	Local Institution - 0073	Clermont Ferrand cedex 01
France	Local Institution - 0089	Clichy
France	Local Institution - 0029	Lyon Cedex 08
France	Local Institution - 0075	Marseille Cedex 5
France	Local Institution - 0079	Nice
France	Local Institution - 0030	Rennes Cedex
France	Local Institution - 0088	Villejuif
Ireland	Local Institution - 0026	Dublin 8	Dublin
Italy	Local Institution	Milano
Italy	Local Institution - 0119	Napoli
Mexico	Local Institution - 0090	Merida	Yucatan
Mexico	Local Institution - 0107	Merida	Yucatan
Mexico	Local Institution - 0108	Oaxaca
Netherlands	Local Institution - 0028	Amsterdam
Netherlands	Local Institution - 0068	Amsterdam
Netherlands	Local Institution - 0027	Groningen
Norway	Local Institution - 0065	Bergen
Norway	Local Institution - 0064	Oslo
Romania	Local Institution - 0055	Bucharest
Romania	Local Institution - 0054	Cluj-Napoca
Romania	Local Institution - 0033	Craiova
Romania	Local Institution - 0060	Iasi
Romania	Local Institution - 0059	Suceava
Russian Federation	Local Institution - 0031	Moscow
Russian Federation	Local Institution - 0092	Ryazan
South Africa	Local Institution	Cape Town	Western CAPE
South Africa	Local Institution	Port Elizabeth	Eastern Cape
South Africa	Local Institution	Pretoria	Gauteng
South Africa	Local Institution - 0017	Sandton	Gauteng
Spain	Local Institution - 0040	A Coruna
Spain	Local Institution - 0039	Barcelona
Spain	Local Institution - 0116	Barcelona
Spain	Local Institution - 0077	Madrid
Spain	Local Institution - 0076	Marbella
Spain	Local Institution - 0041	San Sabastian Gipuzkoa
Sweden	Local Institution - 0067	Goteborg
Sweden	Local Institution - 0037	Lund
Sweden	Local Institution - 0035	Stockholm
Turkey	Local Institution - 0063	Adana
Turkey	Local Institution - 0066	Antalya
Turkey	Local Institution - 0062	Izmir
United Kingdom	Local Institution - 0110	Aberdeen	Aberdeenshire
United Kingdom	Local Institution - 0114	Cardiff
United Kingdom	Local Institution - 0084	Glasgow
United Kingdom	Local Institution - 0086	London	Greater London
United Kingdom	Local Institution - 0082	Newcastle Upon Tyne
United Kingdom	Local Institution - 0081	Sutton	Surrey
United Kingdom	Local Institution - 0083	Wirral	Merseyside
United States	Mission Hospital, Inc	Asheville	North Carolina
United States	Local Institution - 0010	Atlanta	Georgia
United States	Local Institution - 0001	Boston	Massachusetts
United States	Local Institution - 0071	Boston	Massachusetts
United States	Local Institution - 0087	Chicago	Illinois
United States	Local Institution - 0103	Cincinnati	Ohio
United States	Local Institution - 0070	Cleveland	Ohio
United States	Local Institution - 0102	Dallas	Texas
United States	Local Institution - 0015	Decatur	Georgia
United States	Local Institution - 0034	Duarte	California
United States	Ft. Wayne Med Onco-Hema Inc	Fort Wayne	Indiana
United States	Los Angeles Cancer Network	Los Angeles	California
United States	Ucla Department Of Medicine	Los Angeles	California
United States	Local Institution - 0005	Louisville	Kentucky
United States	Local Institution - 0101	New Haven	Connecticut
United States	Oncology Associated Of Western Kentucky	Paducah	Kentucky
United States	Local Institution - 0006	Pittsburgh	Pennsylvania
United States	Local Institution - 0008	Portland	Oregon
United States	Local Institution - 0098	Redondo Beach	California
United States	Local Institution - 0042	Rochester	Minnesota
United States	Local Institution - 0004	Sacramento	California
United States	Local Institution - 0072	San Francisco	California
United States	Local Institution - 0097	San Luis Obispo	California
United States	Central Coast Med Oncology	Santa Maria	California
United States	Donald Guthrie Foundation	Sayre	Pennsylvania
United States	Local Institution - 0038	Seattle	Washington
United States	Local Institution - 0007	Tampa	Florida
United States	University of Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Canada,  Chile,  Czechia,  Finland,  France,  Ireland,  Italy,  Mexico,  Netherlands,  Norway,  Romania,  Russian Federation,  South Africa,  Spain,  Sweden,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Approximately up to 30 months (from FPFV to Data base lock)
Primary	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.	Approximately up to 30 months (from FPFV to Data base lock)
Primary	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.	Approximately up to 30 months (from FPFV to Data base lock)
Secondary	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.	From randomization to end of study. Approximately 63 Months
Secondary	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.	From randomization to disease progression or death. Approximately 63 Months
Secondary	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).	From randomization to disease progression or death. Approximately 63 Months
Secondary	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).	From randomization to disease progression or death. Approximately 63 Months
Secondary	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.	From randomization to death. Approximately 63 Months
Secondary	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.	From randomization to death. Approximately 63 Months
Secondary	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.	From randomization to death. Approximately 63 Months
Secondary	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.	From randomization to end of study. Approximately 63 Months
Secondary	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.	From randomization to end of study. Approximately 63 Months
Secondary	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.	From randomization to end of study. Approximately 63 Months
Secondary	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.	From randomization to end of study. Approximately 63 Months
Secondary	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.	From randomization to disease progression or death. Approximately 63 Months
Secondary	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	From randomization to disease progression or death. Approximately 63 Months
Secondary	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).	From randomization to disease progression or death. Approximately 63 Months
Secondary	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).	From randomization to disease progression or death. Approximately 63 Months
Secondary	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.	From randomization to death. Approximately 63 Months
Secondary	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	From randomization to death. Approximately 63 Months
Secondary	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.	From randomization to death. Approximately 63 Months
Secondary	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	From randomization to death. Approximately 63 Months
Secondary	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).	From randomization to disease progression or death. Approximately 63 Months
Secondary	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).	From randomization to disease progression or death. Approximately 63 Months
Secondary	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).	From randomization to disease progression or death. Approximately 63 Months
Secondary	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).	From randomization to disease progression or death. Approximately 63 Months
Secondary	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).	From randomization to disease progression or death. Approximately 63 Months
Secondary	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.	From randomization to end of study. Approximately 63 Months
Secondary	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	From randomization to death. Approximately 63 Months
Secondary	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).	From randomization to disease progression or death. Approximately 63 Months
Secondary	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).	From randomization to disease progression or death. Approximately 63 Months
Secondary	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.	From randomization to end of study. Approximately 63 Months
Secondary	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	From randomization to death. Approximately 63 Months
Secondary	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).	From randomization to disease progression or death. Approximately 63 Months

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