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BMS-986012 in Relapsed/Refractory SCLC

Primary Purpose

Small Cell Lung Cancer

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

BMS-986012 (anti-fucosyl-GM1)

Nivolumab

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer

Eligibility Criteria

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

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Experimental

Arm Label

Dose Escalation (Monotherapy) Dose -1

Dose Escalation (Monotherapy) Dose 1

Dose Escalation (Monotherapy) Dose 2

Dose Escalation (Monotherapy) Dose 3

Dose Escalation (Monotherapy) Dose 4

Dose Expansion (Monotherapy)- Cohort A (Refractory)

Dose Expansion (Monotherapy) Cohort B (Refractory)

Dose Expansion (Monotherapy) Cohort C (Sensitive)

Dose Expansion (Monotherapy) Cohort D (Sensitive)

Dose Escalation (Combination) Dose 1

Dose Escalation (Combination) Dose 2

Dose Expansion (Combination)- (Refractory and Sensitive)

Arm Description

BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity

BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity in combination with Nivolumab specified dose on specified days

Outcomes

Primary Outcome Measures

Safety as measured by frequency of worst grade of adverse events (AEs), worst grade of serious adverse events (SAEs), incidence of adverse events leading to discontinuations, and deaths

Safety as measured by frequency of worst grade of adverse events (AEs), worst grade of serious adverse events (SAEs), incidence of adverse events leading to discontinuations, and deaths graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), as appropriate

Secondary Outcome Measures

Maximum observed serum concentration (Cmax) for BMS-986012 (anti-fucosyl-GM1)

Maximum observed serum concentration (Cmax) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab

Time of maximum observed serum concentration (Tmax) for BMS-986012 (anti-fucosyl-GM1)

Time of maximum observed serum concentration (Tmax) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab

Observed serum concentration at the end of a dosing interval (Ctau) for BMS-986012 (anti-fucosyl-GM1)

Observed serum concentration at the end of a dosing interval (Ctau) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab

Area under the serum concentration-time curve from time zero to time t (AUC(0-t)) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab

Area under the serum concentration-time curve from time zero to time t (AUC(0-t)) for BMS-986012 (anti-fucosyl-GM1)

Area under the serum concentration-time curve in one dosing interval (AUC(TAU)) for BMS-986012 (anti-fucosyl-GM1)

Area under the serum concentration-time curve in one dosing interval (AUC(TAU)) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab

Best overall response (BOR) for BMS-986012 (anti-fucosyl-GM1)

Best overall response (BOR): defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy

Objective Response Rate (ORR) for BMS-986012 (anti-fucosyl-GM1)

Objective Response Rate (ORR): defined as the total number of subjects whose best overall response (BOR) is either a complete response (CR) or partial response (PR) divided by the total number of subjects in the population of interest

Duration of Response for BMS-986012 (anti-fucosyl-GM1)

Duration of Response: defined as the time between the date of first response and the subsequent date of objectively documented disease progression or death, whichever occurs first

Progression Free Survival (PFS) for BMS-986012 (anti-fucosyl-GM1)

Progression Free Survival (PFS): defined as the time from the first dose of study medication to the date of the first objective documentation of tumor progression or death due to any cause

Progression Free Survival Rate (PFSR) at week "t"; for BMS-986012 (anti-fucosyl-GM1)

Progression Free Survival Rate (PFSR) at week "t": defined as the proportion of subjects who remain progression free and surviving at "t" weeks (t=12, 24, 36, etc)

Overall Survival (OS) for BMS-986012 (anti-fucosyl-GM1)

Overall Survival (OS): defined as the time between the date of first dose of study medication and the date of death. For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive

Overall Survival Rate (OSR) at month "t" for BMS-986012 (anti-fucosyl-GM1)

Overall Survival Rate (OSR) at month "t": defined as the proportion of subjects surviving at "t" months (eg, t=6, 12, 24 months, etc)

Occurrence of specific anti-drug antibodies (ADA) to BMS-986012 every 3 weeks for first 3 cycles then every 4 cycles, at end of treatment and during clinical follow-up

Occurrence of specific anti-drug antibodies (ADA) to BMS-986012 in combination with Nivolumab every 3 weeks for first 3 cycles then every 4 cycles, at end of treatment and during clinical follow-up

Changes in the QTcF following administration of BMS-986012 at multiple timepoints during first cycle, then Day 1 of subsequent cycles and at end of treatment

Changes in the QTcF following administration of BMS-986012 in combination with Nivolumab at multiple timepoints during first cycle, then Day 1 of subsequent cycles and at end of treatment

Full Information

NCT ID

NCT02247349

First Posted

September 19, 2014

Last Updated

February 6, 2023

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT02247349

Brief Title

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

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

November 14, 2014 (Actual)

Primary Completion Date

December 21, 2022 (Actual)

Study Completion Date

December 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

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

Small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

106 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose Escalation (Monotherapy) Dose -1

Arm Type

Experimental

Arm Description

BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity

Arm Title

Dose Escalation (Monotherapy) Dose 1

Arm Type

Experimental

Arm Description

BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity

Arm Title

Dose Escalation (Monotherapy) Dose 2

Arm Type

Experimental

Arm Description

BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity

Arm Title

Dose Escalation (Monotherapy) Dose 3

Arm Type

Experimental

Arm Description

BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity

Arm Title

Dose Escalation (Monotherapy) Dose 4

Arm Type

Experimental

Arm Description

BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity

Arm Title

Dose Expansion (Monotherapy)- Cohort A (Refractory)

Arm Type

Experimental

Arm Description

BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity

Arm Title

Dose Expansion (Monotherapy) Cohort B (Refractory)

Arm Type

Experimental

Arm Description

BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity

Arm Title

Dose Expansion (Monotherapy) Cohort C (Sensitive)

Arm Type

Experimental

Arm Description

BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity

Arm Title

Dose Expansion (Monotherapy) Cohort D (Sensitive)

Arm Type

Experimental

Arm Description

BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity

Arm Title

Dose Escalation (Combination) Dose 1

Arm Type

Experimental

Arm Description

Arm Title

Dose Escalation (Combination) Dose 2

Arm Type

Experimental

Arm Description

Arm Title

Dose Expansion (Combination)- (Refractory and Sensitive)

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

BMS-986012 (anti-fucosyl-GM1)

Intervention Type

Biological

Intervention Name(s)

Nivolumab

Primary Outcome Measure Information:

Title

Safety as measured by frequency of worst grade of adverse events (AEs), worst grade of serious adverse events (SAEs), incidence of adverse events leading to discontinuations, and deaths

Description

Time Frame

Weekly for 1st and 2nd 21-day cycles, then once every 3 weeks during study treatment, at end of treatment and every 30 days during clinical follow-up until resolution of adverse events or 100 days after the last dose of study medication (Approx 3 years)

Secondary Outcome Measure Information:

Title

Maximum observed serum concentration (Cmax) for BMS-986012 (anti-fucosyl-GM1)

Time Frame

At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)

Title

Maximum observed serum concentration (Cmax) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab

Time Frame

At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)

Title

Time of maximum observed serum concentration (Tmax) for BMS-986012 (anti-fucosyl-GM1)

Time Frame

At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)

Title

Time of maximum observed serum concentration (Tmax) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab

Time Frame

At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)

Title

Observed serum concentration at the end of a dosing interval (Ctau) for BMS-986012 (anti-fucosyl-GM1)

Time Frame

At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)

Title

Observed serum concentration at the end of a dosing interval (Ctau) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab

Time Frame

At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)

Title

Area under the serum concentration-time curve from time zero to time t (AUC(0-t)) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab

Time Frame

At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)

Title

Area under the serum concentration-time curve from time zero to time t (AUC(0-t)) for BMS-986012 (anti-fucosyl-GM1)

Time Frame

At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)

Title

Area under the serum concentration-time curve in one dosing interval (AUC(TAU)) for BMS-986012 (anti-fucosyl-GM1)

Time Frame

At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)

Title

Area under the serum concentration-time curve in one dosing interval (AUC(TAU)) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab

Time Frame

At multiple timepoints during first 4 cycles then every 4th cycle, at end of treatment and during clinical follow-up (Approx duration of study 3 years)

Title

Best overall response (BOR) for BMS-986012 (anti-fucosyl-GM1)

Description

Best overall response (BOR): defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy

Time Frame

Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)

Title

Objective Response Rate (ORR) for BMS-986012 (anti-fucosyl-GM1)

Description

Time Frame

Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)

Title

Duration of Response for BMS-986012 (anti-fucosyl-GM1)

Description

Duration of Response: defined as the time between the date of first response and the subsequent date of objectively documented disease progression or death, whichever occurs first

Time Frame

Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)

Title

Progression Free Survival (PFS) for BMS-986012 (anti-fucosyl-GM1)

Description

Progression Free Survival (PFS): defined as the time from the first dose of study medication to the date of the first objective documentation of tumor progression or death due to any cause

Time Frame

Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)

Title

Progression Free Survival Rate (PFSR) at week "t"; for BMS-986012 (anti-fucosyl-GM1)

Description

Progression Free Survival Rate (PFSR) at week "t": defined as the proportion of subjects who remain progression free and surviving at "t" weeks (t=12, 24, 36, etc)

Time Frame

Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)

Title

Overall Survival (OS) for BMS-986012 (anti-fucosyl-GM1)

Description

Time Frame

Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)

Title

Overall Survival Rate (OSR) at month "t" for BMS-986012 (anti-fucosyl-GM1)

Description

Overall Survival Rate (OSR) at month "t": defined as the proportion of subjects surviving at "t" months (eg, t=6, 12, 24 months, etc)

Time Frame

Approximately every 6 weeks until disease progression or every 3-4 months for subjects with a confirmed response (Approx duration of study 3 years)

Title

Occurrence of specific anti-drug antibodies (ADA) to BMS-986012 every 3 weeks for first 3 cycles then every 4 cycles, at end of treatment and during clinical follow-up

Time Frame

Every 3 weeks for first 3 cycles then every 4 cycles, at end of treatment and during clinical follow-up (Approx duration of study 3 years)

Title

Occurrence of specific anti-drug antibodies (ADA) to BMS-986012 in combination with Nivolumab every 3 weeks for first 3 cycles then every 4 cycles, at end of treatment and during clinical follow-up

Time Frame

Every 3 weeks for first 3 cycles then every 4 cycles, at end of treatment and during clinical follow-up (Approx duration of study 3 years)

Title

Changes in the QTcF following administration of BMS-986012 at multiple timepoints during first cycle, then Day 1 of subsequent cycles and at end of treatment

Time Frame

At multiple timepoints during first cycle, then Day 1 of subsequent cycles and at end of treatment (Approx duration of study 3 years)

Title

Changes in the QTcF following administration of BMS-986012 in combination with Nivolumab at multiple timepoints during first cycle, then Day 1 of subsequent cycles and at end of treatment

Time Frame

At multiple timepoints during first cycle, then Day 1 of subsequent cycles and at end of treatment (Approx duration of study 3 years)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Memorial Sloan Kettering Nassau

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Local Institution - 0001

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Wake Forest Baptist Health

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Local Institution

City

St. Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

Local Institution - 0011

City

Brisbane

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Local Institution

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

Local Institution - 0015

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Local Institution - 0012

City

Liege

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Cross Cancer Institute

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

Nova Scotia Health Authority QEII Health Sciences Centre

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

Juravinski Cancer Centre

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8V 5C2

Country

Canada

Facility Name

Local Institution - 0010

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4L6

Country

Canada

Facility Name

University Health Network - Princess Margaret Cancer Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Local Institution - 0008

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Radboud Universitair Medisch Centrum

City

Nijmegen

ZIP/Postal Code

6525 GA

Country

Netherlands

Facility Name

Local Institution - 0009

City

San Juan

ZIP/Postal Code

00927

Country

Puerto Rico

12. IPD Sharing Statement

Links:

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

BMS Clinical Trial Information

URL

https://www.bmsstudyconnect.com/us/en/home.html

Description

BMS Clinical Trial Patient Recruiting

Learn more about this trial

BMS-986012 in Relapsed/Refractory SCLC

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BMS-986012 in Relapsed/Refractory SCLC

Small Cell Lung Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial