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
FDA Safety Alerts and Recalls
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
ID
NCT02341625
Phase
Phase 1/2
Study Type
Interventional
Last Updated
July 23, 2018