BMS-986012 in Relapsed/Refractory SCLC

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Small Cell Lung Cancer

Treatments: Biological: BMS-986012 (anti-fucosyl-GM1); Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02247349

CA001-030

2014-002372-89 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 12 patient groups

Dose Escalation (Monotherapy) Dose -1

Experimental group

Description:

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

Treatment:

Biological: BMS-986012 (anti-fucosyl-GM1)

Dose Escalation (Monotherapy) Dose 1

Experimental group

Description:

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

Treatment:

Biological: BMS-986012 (anti-fucosyl-GM1)

Dose Escalation (Monotherapy) Dose 2

Experimental group

Description:

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

Treatment:

Biological: BMS-986012 (anti-fucosyl-GM1)

Dose Escalation (Monotherapy) Dose 3

Experimental group

Description:

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

Treatment:

Biological: BMS-986012 (anti-fucosyl-GM1)

Dose Escalation (Monotherapy) Dose 4

Experimental group

Description:

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

Treatment:

Biological: BMS-986012 (anti-fucosyl-GM1)

Dose Expansion (Monotherapy)- Cohort A (Refractory)

Experimental group

Description:

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

Treatment:

Biological: BMS-986012 (anti-fucosyl-GM1)

Dose Expansion (Monotherapy) Cohort B (Refractory)

Experimental group

Description:

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

Treatment:

Biological: BMS-986012 (anti-fucosyl-GM1)

Dose Expansion (Monotherapy) Cohort C (Sensitive)

Experimental group

Description:

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

Treatment:

Biological: BMS-986012 (anti-fucosyl-GM1)

Dose Expansion (Monotherapy) Cohort D (Sensitive)

Experimental group

Description:

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

Treatment:

Biological: BMS-986012 (anti-fucosyl-GM1)

Dose Escalation (Combination) Dose 1

Experimental group

Description:

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

Treatment:

Biological: BMS-986012 (anti-fucosyl-GM1)

Biological: Nivolumab

Dose Escalation (Combination) Dose 2

Experimental group

Description:

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

Treatment:

Biological: BMS-986012 (anti-fucosyl-GM1)

Biological: Nivolumab

Dose Expansion (Combination)- (Refractory and Sensitive)

Experimental group

Description:

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

Treatment:

Biological: BMS-986012 (anti-fucosyl-GM1)

Biological: Nivolumab