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Trial ID CA008-002  |   NCT02341625

A Study of BMS-986148 in Patients With Select Advanced Solid Tumors

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Summary

  • Phase 1/Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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.

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Key Eligibility Criteria

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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Part 1: Ascending dose of BMS-986148

ASSIGNED INTERVENTION
  • Drug: BMS-986148

Study Arms

Experimental: Part 2: Expansion dose of BMS-986148

ASSIGNED INTERVENTION
  • Drug: BMS-986148

Study Arms

Experimental: Part 3A: Ascending dose of BMS-986148

ASSIGNED INTERVENTION
  • Biological: Nivolumab Drug: BMS-986148

Study Arms

Experimental: Part 3B: Expansion dose of BMS-986148

ASSIGNED INTERVENTION
  • Biological: Nivolumab Drug: BMS-986148