A Dose Frequency Optimization,Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received Up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks

Lung Cancer Clinical Trial

— CheckMate 384  

Official title:

A Dose Frequency Optimization, Phase IIIB/IV Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02713867
• Other study ID #: CA209-384
• Status: Completed
• Phase: Phase 3
• Start date: May 24, 2016
• Est. completion date: January 18, 2022

Study information

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

Clinical Trial Summary

The primary objective of this study is to compare PFS (progression-free survival) rate at 6 months and at 1 year after randomization, of Nivolumab 480 mg every 4 weeks with nivolumab 240 mg every 2 weeks in subjects with advanced/metastatic (Stage IIIb/IV) NSCLC (non-Sq and Sq).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: January 18, 2022
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Histologically or cytologically documented Squamous or non-Squamous Non-small cell lung cancer (NSCLC) (Stage IIIB/IV), or recurrent or progressive disease following multimodal therapy

• Patients must have received pre-study nivolumab for up to 12 months and have 2 consecutive tumor assessments confirming Complete response (CR), Partial response (PR), or Stable disease (SD)

• Measurable disease before start of pre-study nivolumab treatment

• Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2

Exclusion Criteria:

• Carcinomatous meningitis

• Untreated, symptomatic Central nervous system (CNS) metastases

• Symptomatic interstitial lung disease

Other protocol defined inclusion/exclusion criteria could apply

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Biological:
• Nivolumab

Locations

Country	Name	City	State
Australia	Local Institution - 0054	Bedford Park	South Australia
Australia	Local Institution - 0056	Elizabeth Vale	South Australia
Australia	Local Institution - 0053	Heidelberg	Victoria
Australia	Local Institution - 0057	Hobart	Tasmania
Australia	Local Institution - 0055	Kurralta Park	South Australia
Australia	Local Institution - 0058	Murdoch	Western Australia
Australia	Local Institution - 0052	St. Leonards	New South Wales
Australia	Local Institution - 0118	Waratah	New South Wales
Australia	Local Institution - 0117	Westmead,	New South Wales
Australia	Local Institution - 0093	Woolloongabba	Queensland
Austria	Local Institution	Wien
Canada	Local Institution - 0146	Laval	Quebec
Canada	Local Institution - 0145	Montreal	Quebec
Canada	Local Institution - 0059	Newmarket	Ontario
Canada	Local Institution	Quebec
Canada	Local Institution - 0060	St. Jerome	Quebec
France	Local Institution - 0081	Angers
France	Local Institution - 0105	Angers
France	Local Institution - 0080	Bayonne
France	Local Institution - 0076	Clermont-Ferrand Cedex 01
France	Local Institution - 0077	Le Mans
France	Local Institution - 0072	Mulhouse
France	Local Institution - 0078	Nimes
France	Local Institution - 0083	Paris
France	Local Institution - 0095	Paris
France	Local Institution	Pontoise
France	Local Institution - 0075	Suresnes Cedex
France	Local Institution - 0079	Tours
France	Local Institution - 0097	Vandoeuvre-les-Nancy
France	Local Institution - 0096	Villefranche-sur-Saone Cedex
Germany	Local Institution	Bad Berka
Germany	Local Institution - 0073	Berlin
Germany	Local Institution - 0063	Dresden
Germany	Local Institution	Freiburg
Germany	Local Institution - 0102	Gauting
Germany	Local Institution - 0062	Greifenstein
Germany	Local Institution - 0061	Hamburg
Germany	Local Institution - 0113	Hannover
Germany	Local Institution - 0064	Kassel
Germany	Local Institution - 0106	Kiel
Germany	Local Institution - 0065	Leipzig
Germany	Local Institution	Lostau
Germany	Local Institution - 0066	Moers
Germany	Local Institution - 0067	Nürnberg
Italy	Local Institution - 0086	Localita San Filippo Lucca
Italy	Local Institution - 0085	Monza
Italy	Local Institution - 0088	Napoli
Italy	Local Institution - 0087	Roma
Spain	Local Institution - 0069	Barcelona
Spain	Local Institution - 0104	El Palmar
Spain	Local Institution - 0068	Las Palmas de Gran Canaria
Spain	Local Institution - 0070	Sevilla
United States	Local Institution - 0023	Abilene	Texas
United States	Local Institution - 0035	Albany	New York
United States	Texas Oncology - Amarillo	Amarillo	Texas
United States	Local Institution - 0008	Athens	Georgia
United States	CBCC Global Research, Inc.	Bakersfield	California
United States	Mary Bird Perkins Cancer Center	Baton Rouge	Louisiana
United States	Southern California Permanente Medical Group	Bellflower	California
United States	Local Institution - 0042	Bethesda	Maryland
United States	Local Institution - 0004	Birmingham	Alabama
United States	Local Institution - 0109	Brewer	Maine
United States	Hematology And Oncology Associates	Canton	Ohio
United States	Local Institution - 0020	Charleston	South Carolina
United States	Local Institution - 0037	Cincinnati	Ohio
United States	Local Institution - 0132	Cincinnati	Ohio
United States	MetroHealth Cancer Care Center	Cleveland	Ohio
United States	Local Institution - 0142	Columbus	Georgia
United States	Local Institution - 0011	Dallas	Texas
United States	Local Institution - 0022	Dallas	Texas
United States	Texas Oncology, P.A.	Denton	Texas
United States	Local Institution - 0017	Denver	Colorado
United States	Texas Oncology, P.A.	El Paso	Texas
United States	Innova Schar Cancer Institute	Falls Church	Virginia
United States	Local Institution - 0025	Flower Mound	Texas
United States	Local Institution - 0122	Fort Collins	Colorado
United States	Local Institution - 0038	Fort Myers	Florida
United States	Local Institution - 0050	Fort Wayne	Indiana
United States	Local Institution - 0099	Fort Wayne	Indiana
United States	St Jude Hospital Yorba Linda	Fullerton	California
United States	Jones Clinic PC	Germantown	Tennessee
United States	Ingalls Health System	Harvey	Illinois
United States	Local Institution - 0089	Hollywood	Florida
United States	Texas Oncology, P.A.	Houston	Texas
United States	Innova Schar Cancer Institute	Indianapolis	Indiana
United States	Local Institution - 0013	Johnson City	New York
United States	Local Institution - 0141	Lebanon	New Hampshire
United States	Texas Oncology, P.A.	Longview	Texas
United States	Local Institution - 0046	Los Angeles	California
United States	Local Institution - 0121	Marietta	Georgia
United States	Local Institution - 0129	Massillon	Ohio
United States	Hematology Oncology Consultants, Pc	Medford	Oregon
United States	Local Institution - 0119	Midland	Texas
United States	Local Institution - 0120	Minneapolis	Minnesota
United States	Local Institution - 0036	Nashville	Tennessee
United States	Local Institution - 0137	New Orleans	Louisiana
United States	Local Institution - 0098	Niles	Illinois
United States	Local Institution - 0026	Ocala	Florida
United States	Local Institution - 0014	Omaha	Nebraska
United States	Local Institution - 0126	Orange	California
United States	Local Institution - 0112	Paducah	Kentucky
United States	Local Institution - 0001	Pensacola	Florida
United States	Local Institution - 0100	Peoria	Illinois
United States	Local Institution - 0030	Phoenix	Arizona
United States	Local Institution - 0041	Phoenix	Arizona
United States	Local Institution - 0127	Pinehurst	North Carolina
United States	Local Institution - 0005	Pittsburgh	Pennsylvania
United States	Texas Oncology, P.A.	Plano	Texas
United States	Torrance Health Association	Redondo Beach	California
United States	Local Institution - 0039	Saint Petersburg	Florida
United States	Texas Oncology, P.A.	San Antonio	Texas
United States	Sharp Memorial Hospital	San Diego	California
United States	Local Institution - 0010	Santa Barbara	California
United States	Local Institution - 0044	Santa Maria	California
United States	Texas Oncology, P.A.	Sherman	Texas
United States	Local Institution - 0124	Sioux Falls	South Dakota
United States	Local Institution - 0136	Southfield	Michigan
United States	Cancer Care Northwest	Spokane Valley	Washington
United States	Local Institution - 0125	Springfield	Massachusetts
United States	Mercy Medical Research Institute	Springfield	Missouri
United States	Texas Oncology, P.A.	Sugar Land	Texas
United States	Local Institution - 0116	Tupelo	Mississippi
United States	Local Institution - 0143	Urbana	Illinois
United States	Local Institution - 0130	Vallejo	California
United States	Local Institution - 0031	Vancouver	Washington
United States	Local Institution - 0123	Wichita	Kansas
United States	Local Institution - 0034	Wichita Falls	Texas
United States	Shenandoah Oncology	Winchester	Virginia
United States	Yakima Valley Memorial Hospital/North Star Lodge	Yakima	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  France,  Germany,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival Rate (PFSR) at 6 Months	The proportion of participants remaining progression free and surviving at 6 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Progression is defined as 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.	At 6 Months
Primary	Progression Free Survival Rate (PFSR) at 12 Months	The proportion of participants remaining progression free and surviving at 6 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Progression is defined as 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.	At 12 Months
Secondary	Progression Free Survival Rate (PFSR) at 24 Months	The proportion of participants remaining progression free and surviving at 6 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Progression is defined as 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.	At 24 Months
Secondary	Progression Free Survival Rate (PFSR) by Tumor Histology at 12 Months	The proportion of participants remaining progression free and surviving at 6 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Progression is defined as 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.	At 12 Months
Secondary	Progression Free Survival Rate (PFSR) by Response Criteria at 12 Months	The proportion of participants remaining progression free and surviving at 12 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.; 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.; Stable Disease (SD): Neither sufficient shrinkage from the baseline study to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.	At 12 Months
Secondary	Overall Survival (OS) Rate at 12 Months	The proportion of participants alive at 12 months. OS is defined as time from the date of randomization to the date of death. Participants who did not die by the end of the study will be censored at the last known date alive.	At 12 Months
Secondary	Overall Survival (OS) Rate up to 60 Months	The proportion of participants alive up to 60 months. OS is defined as time from the date of randomization to the date of death. Participants who did not die by the end of the study will be censored at the last known date alive.	From randomization to the date of death, Up to 60 Months
Secondary	Overall Survival Rate by Histology at 12 Months	The proportion of participants alive at 12 months. OS is defined as time from the date of randomization to the date of death. Participants who did not die by the end of the study will be censored at the last known date alive.; OS rate by histology did not have data collected after 12 months randomization.	at 12 Months
Secondary	Overall Survival Rate by Response Criteria at 12 Months	The proportion of participants alive at 12 months. OS is defined as time from the date of randomization to the date of death. Participants who did not die by the end of the study will be censored at the last known date alive.; 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.; Stable Disease (SD): Neither sufficient shrinkage from the baseline study to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.; OS rate by response did not have data collected after 12 months randomization.	12 Months
Secondary	Percentage of Participants With an Adverse Events (AEs)	Percentage of participants with an Adverse Event due to any cause; An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.	Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
Secondary	Percentage of Participants With an Serious Adverse Events (SAEs)	Percentage of participants with an Serious Adverse Event due to any cause.; A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death; is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe); requires inpatient hospitalization or causes prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is an important medical event (defined as a medical event(s) that may not be immediately life-threatening or result in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the participant or may require intervention [eg, medical, surgical] to prevent one of the other serious outcomes listed in the definition above.)	Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
Secondary	Percentage of Participants With an Adverse Events Leading to Discontinuation (AEsDC)	Percentage of Participants with an Adverse Event leading to discontinuation (AEsDC) due to any cause.; An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.	Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
Secondary	Percentage of Participants With an Immune Mediated Adverse Events (IMAEs)	Percentage of Participants with an Immune Mediated Adverse Events treated with Immune-Modulating Medication	Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
Secondary	Percentage of Participants With an Select Adverse Events	Percentage of Participants with an Select Adverse Event due to any cause; Select adverse events include adverse events in the following systems: Gastrointestinal, Hepatic, Pulmonary, Renal, Skin, Hypersensitivity/Infusion reaction and Endocrine.	Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
Secondary	Percentage of Participants With an Event of Special Interest (ESI)	Other ESI included the following categories: demyelination, encephalitis, Guillain-Barré syndrome (GBS), myasthenic syndrome, pancreatitis, uveitis, myositis, myocarditis, rhabdomyolysis, and Graft Versus Host Disease (GVHD).	Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
Secondary	Percentage of Participants Who Experienced Death	Percentage of Participants who experienced Death due to any cause	Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)
Secondary	Number of Participants With Laboratory Test Abnormalities	Number of participants with any laboratory test result that is clinically significant or meets the definition of an SAE (Grade 3+4 combined)	Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls