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Active, Not Recruiting

BMS-986012 in Relapsed/Refractory SCLC - CA001-030

Updated: 20 July, 2021   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1/Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Dose Escalation (Combination) Dose 1
Biological: BMS-986012 (anti-fucosyl-GM1) Biological: Nivolumab
Experimental: Dose Escalation (Combination) Dose 2
Biological: BMS-986012 (anti-fucosyl-GM1) Biological: Nivolumab
Experimental: Dose Escalation (Monotherapy) Dose -1
Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Escalation (Monotherapy) Dose 1
Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Escalation (Monotherapy) Dose 2
Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Escalation (Monotherapy) Dose 3
Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Escalation (Monotherapy) Dose 4
Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Expansion (Combination)- (Refractory and Sensitive)
Biological: Nivolumab Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Expansion (Monotherapy) Cohort B (Refractory)
Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Expansion (Monotherapy) Cohort C (Sensitive)
Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Expansion (Monotherapy) Cohort D (Sensitive)
Biological: BMS-986012 (anti-fucosyl-GM1)
Experimental: Dose Expansion (Monotherapy)- Cohort A (Refractory)
Biological: BMS-986012 (anti-fucosyl-GM1)

Key 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

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com