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Closed (no longer recruiting)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

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 patients with Small Cell Lung Cancer (SCLC).

Cancer

Lung Cancers Lung cancer

Age

People18 - 75

Phase

I/II

Trial Acronym

anti-fucosyl-GM1

More information

Trial Identifiers

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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

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.

Ask your doctor if this trial could be right for you.

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