Clinical trial NCT02247349: BMS-986012 in Relapsed/Refractory SCLC
Official title: A Phase 1/2 Multicenter Study of BMS-986012 in Subjects With Relapsed/Refractory Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-09-25
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety, tolerability, pharmacokinetics, immunogenicity, antitumor activity and pharmacodynamics of BMS-986012 alone and in combination with nivolumab in patients with relapsed/refractory SCLC.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Histological or cytological confirmed small cell lung cancer (SCLC)
* Performance Status 0-1
* Adequate organ function
* Measurable disease

Exclusion Criteria:

* Known or suspected brain metastasis
* Small cell cancer not lung in origin
* Significant or acute medical illness
* Uncontrolled or significant cardiac disease
* Infection
* ≥ Grade 2 peripheral neuropathy
* Concomitant malignancies
* HIV related disease or known or suspected HIV+
* Hepatitis B or C infection
* ECG abnormalities as defined by the protocol
* Allergies or hypersensitivities to monoclonal antibodies, BMS-986012 or related compounds, including fucosyl-GM1 vaccine and Nivolumab

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From first dose to 100 days post last dose (Up to 64 months)
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From first dose to 100 days post last dose (Up to 64 months)
measure: Number of Participants With Adverse Events (AEs) Leading to Discontinuation
timeFrame: From first dose to 100 days post last dose (Up to 64 months)
measure: Number of Participants Who Died
timeFrame: From first dose to 100 days post last dose (Up to 64 months)
measure: Number of Participants With Abnormal Hepatic Test
timeFrame: From first dose to 100 days post last dose (Up to 64 months)
Secondary outcomes:
measure: BMS-986012 Maximum Observed Serum Concentration (Cmax)
timeFrame: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
measure: BMS-986012 Time of Maximum Observed Serum Concentration (Tmax)
timeFrame: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
measure: BMS-986012 Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC (0-T))
timeFrame: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
measure: BMS-986012 Area Under the Serum Concentration-time Curve in One Dosing Interval AUC (TAU)
timeFrame: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
measure: BMS-986012 Observed Serum Concentration at the End of a Dosing Interval (Ctau)
timeFrame: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
measure: BMS-986012 Total Body Clearance (CLT)
timeFrame: Cycle 1 day 1, cycle 3 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
measure: BMS-986012 Trough Observed Serum Concentration (Ctrough)
timeFrame: Cycle 2 day 1, cycle 3 day 1, cycle 4 day 1, cycle 7 day 1, cycle 11 day 1. cycle 15 day 1 (including pre-dose, 1, 2, 4, 8, 24, 72, 168, 336 hours post dose)
measure: BMS-986012 Average Concentration Over a Dosing Interval (Css-avg)
timeFrame: Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
measure: BMS-986012 Accumulation Index (AI_AUC)
timeFrame: Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
measure: BMS-986012 Cmax Accumulation Index (AI_Cmax)
timeFrame: Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
measure: BMS-986012 Ctau Accumulation Index (AI_Ctau)
timeFrame: Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
measure: BMS-986012 Effective Elimination (T-HALFeff)
timeFrame: Cycle 3 day 1 (including pre-dose, 1, 2, 4, and 8 hours post dose)
measure: Best Overall Response (BOR)
timeFrame: From first dose to the last tumor assessment prior to subsequent therapy (Up to 97 months)
measure: Objective Response Rate (ORR)
timeFrame: From first dose date to the date of first documented disease progression (Up to 97 months)
measure: Duration of Response (DoR)
timeFrame: From the date of first dose to the date of the first documented tumor progression or death due to any cause, whichever occurs first (Up to 97 months)
measure: Progression Free Survival (PFS)
timeFrame: From first dose to the date of first documented disease progression or death due to any cause, if death occurred within 100 days after last BMS-986012 dose (Up to 97 months)
measure: Progression Free Survival Rate (PFSR)
timeFrame: Weeks 12, 24, 36, 48, 60, 72
measure: Number of Participants With Anti-BMS-986012 Antibodies (ADA)
timeFrame: From first dose to 100 days following the last BMS-986012 dose (Up to 64 months)
Other outcomes:
Locations:
city: New York
country: United States
facility: Local Institution - 0004
state: New York
city: Durham
country: United States
facility: Local Institution - 0001
state: North Carolina
city: Winston-Salem
country: United States
facility: Local Institution - 0021
state: North Carolina
city: St. Leonards
country: Australia
facility: Local Institution - 0020
state: New South Wales
city: Brisbane
country: Australia
facility: Local Institution - 0011
state: Queensland
city: Clayton
country: Australia
facility: Local Institution - 0002
state: Victoria
city: Gent
country: Belgium
facility: Local Institution - 0015
city: Liege
country: Belgium
facility: Local Institution - 0012
city: Edmonton
country: Canada
facility: Local Institution - 0003
state: Alberta
city: Halifax
country: Canada
facility: Local Institution - 0017
state: Nova Scotia
city: Hamilton
country: Canada
facility: Local Institution - 0019
state: Ontario
city: London
country: Canada
facility: Local Institution - 0010
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0007
state: Ontario
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0008
city: Nijmegen
country: Netherlands
facility: Local Institution - 0013
city: San Juan
country: Puerto Rico
facility: Local Institution - 0009
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: