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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 (CheckMate 384)

Primary Purpose

Lung Cancer

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Nivolumab

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

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

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Nivolumab 240 mg

Nivolumab 480 mg

Arm Description

Nivolumab 240 mg Every 2 Weeks

Nivolumab 480 mg Every 4 Weeks

Outcomes

Primary Outcome Measures

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.

Progression Free Survival Rate (PFSR) at 12 Months

Secondary Outcome Measures

Progression Free Survival Rate (PFSR) at 24 Months

Progression Free Survival Rate (PFSR) by Tumor Histology at 12 Months

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.

Overall Survival (OS) Rate at 12 Months

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.

Overall Survival Rate by Histology at 12 Months

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.

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.

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.)

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.

Percentage of Participants With an Immune Mediated Adverse Events (IMAEs)

Percentage of Participants with an Immune Mediated Adverse Events treated with Immune-Modulating Medication

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.

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).

Percentage of Participants Who Experienced Death

Percentage of Participants who experienced Death due to any cause

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)

Full Information

NCT ID

NCT02713867

First Posted

March 11, 2016

Last Updated

January 18, 2023

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT02713867

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

May 24, 2016 (Actual)

Primary Completion Date

July 15, 2019 (Actual)

Study Completion Date

January 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

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

Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

363 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nivolumab 240 mg

Arm Type

Active Comparator

Arm Description

Nivolumab 240 mg Every 2 Weeks

Arm Title

Nivolumab 480 mg

Arm Type

Experimental

Arm Description

Nivolumab 480 mg Every 4 Weeks

Intervention Type

Biological

Intervention Name(s)

Nivolumab

Primary Outcome Measure Information:

Title

Progression Free Survival Rate (PFSR) at 6 Months

Description

Time Frame

At 6 Months

Title

Progression Free Survival Rate (PFSR) at 12 Months

Description

Time Frame

At 12 Months

Secondary Outcome Measure Information:

Title

Progression Free Survival Rate (PFSR) at 24 Months

Description

Time Frame

At 24 Months

Title

Progression Free Survival Rate (PFSR) by Tumor Histology at 12 Months

Description

Time Frame

At 12 Months

Title

Progression Free Survival Rate (PFSR) by Response Criteria at 12 Months

Description

Time Frame

At 12 Months

Title

Overall Survival (OS) Rate at 12 Months

Description

Time Frame

At 12 Months

Title

Overall Survival (OS) Rate up to 60 Months

Description

Time Frame

From randomization to the date of death, Up to 60 Months

Title

Overall Survival Rate by Histology at 12 Months

Description

Time Frame

at 12 Months

Title

Overall Survival Rate by Response Criteria at 12 Months

Description

Time Frame

12 Months

Title

Percentage of Participants With an Adverse Events (AEs)

Description

Time Frame