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No longer recruiting (closed or complete)Last updated: 21 December 2023

anti-fucosyl-GM1: This phase I/II trial is investigating BMS-986012 alone and in combination with nivolumab for the treatment of relapsed or refractory Small Cell Lung Cancer (SCLC)A Phase 1/2 Multicenter Study of BMS-986012 in Subjects With Relapsed/Refractory Small Cell Lung Cancer

Trial purpose

Medical clipboardCancer treatment

Tumor type

Lung Cancers Lung cancer

Age

People18 - 75

Trial acronym

anti-fucosyl-GM1

Clinical summary

Summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics, immunogenicity, antitumor activity and pharmacodynamics of BMS-986012 in subjects with relapsed/refractory SCLC.

Conditions

This trial is treating people with Small Cell Lung Cancer (SCLC)

Eligibility

Inclusion

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

  • Histological or cytological confirmed small cell lung cancer (SCLC)
  • Performance Status 0-1
  • Adequate organ function
  • Measurable disease

Exclusion

  • 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

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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No longer recruiting (closed or complete) hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

A Phase 1/2 Multicenter Study of BMS-986012 in Subjects With Relapsed/Refractory Small Cell Lung Cancer

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