BMS-986012 in Relapsed/Refractory SCLC

Part of paid clinical trials in New York, New York.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02247349
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BMS-986012 (anti-fucosyl-GM1) — BIOLOGICAL
  • Nivolumab — BIOLOGICAL

Study Details

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.

Key Dates

Start date
Nov 14, 2014
Status verified
Feb 2024
Primary completion
Dec 21, 2022
Completion
Dec 22, 2022

Study Design

Enrollment
106 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation (Monotherapy) Dose -1
    BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
  • Experimental: Dose Escalation (Monotherapy) Dose 1
    BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
  • Experimental: Dose Escalation (Monotherapy) Dose 2
    BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
  • Experimental: Dose Escalation (Monotherapy) Dose 3
    BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
  • Experimental: Dose Escalation (Monotherapy) Dose 4
    BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
  • Experimental: Dose Expansion (Monotherapy)- Cohort A (Refractory)
    BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
  • Experimental: Dose Expansion (Monotherapy) Cohort B (Refractory)
    BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
  • Experimental: Dose Expansion (Monotherapy) Cohort C (Sensitive)
    BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
  • Experimental: Dose Expansion (Monotherapy) Cohort D (Sensitive)
    BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
  • Experimental: Dose Escalation (Combination) Dose 1
    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
  • Experimental: Dose Escalation (Combination) Dose 2
    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
  • Experimental: Dose Expansion (Combination)- (Refractory and Sensitive)
    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

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) [ Time Frame: From first dose to 100 days post last dose (Up to 64 months) ]

Locations (3)

FacilityCityStateZIPSite coordinators
Local Institution - 0004New YorkNew York10065-
Local Institution - 0001DurhamNorth Carolina27710-
Local Institution - 0021Winston-SalemNorth Carolina27157-

Find similar trials in New York, NY

By condition
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By specialty
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By research site
Local Institution - 0004· New York, NYLocal Institution - 0001· Durham, NCLocal Institution - 0021· Winston-Salem, NC

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