Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

Summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics, immunogenicity, antitumor activity and pharmacodynamics of BMS-986148 administered alone and in combination with nivolumab in patients with mesothelioma, non-small cell lung cancer, ovarian cancer, pancreatic cancer and gastric cancer.

Official Title

A Phase I/IIa Study of BMS-986148, a Mesothelin Directed Antibody Drug Conjugate, in Subjects With Select Advanced Solid Tumors

Keywords

Advanced Cancer Nivolumab BMS-986148

Eligibility

For people ages 18 years and up

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

Inclusion Criteria:

  • Must have pancreatic, ovarian, gastric, non-small cell cancer or mesothelioma. For dose expansion, must have tumor that is positive for mesothelin
  • Expected to have life expectancy of at least 3 months
  • Men and women 18 years old or older (or local age of majority)
  • Must have measurable tumor per Response Evaluation Criteria In Solid Tumors (RECIST)or modified RECIST for malignant pleural mesothelioma
  • ECOG of 0 to 1

Exclusion Criteria:

  • Cancer metastases in the brain
  • Moderate eye disorders
  • Active infection or past hepatitis B or C infection
  • Major surgery less than 1 month before the start of the study
  • Uncontrolled heart disease
  • Impaired liver or bone marrow function
  • History of allergy to mesothelin-directed antibodies, tubulysin, monoclonal antibodies, nivolumab or related compounds

Locations

  • UC San Diego Moores Cancer Ctr
    La Jolla California 92093-0698 United States
  • Cross Cancer Institute
    Edmonton Alberta T6G 1Z2 Canada

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
ID
NCT02341625
Phase
Phase 1/2
Study Type
Interventional
Last Updated