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

First listed
Sep 25, 2014
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-

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