Study of BMS-986178 Monotherapy or in Combination With Nivolumab or Ipilimumab in Subjects With Advanced Solid Tumors

Phase 1

• Conditions: MedDRA version: 19.0 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]; Advanced Solid Tumors

• Registration Number: EUCTR2015-004816-39-ES
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-06
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 245

Inclusion Criteria

• Patients must have at least 1 standard treatment regimen in the advanced, recurrent or metastatic setting
• ECOG (Eastern Cooperative Oncology Group) 0-1
• Men and women 18 years old or older
• At least one measurable lesion at baseline by CT (computed tomography) or MRI (magnetic resonance imaging) as per RECIST (Response Evaluation Criteria In Solid Tumors) v1.1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 145

Exclusion Criteria

• Known central nervous system metastases or central nervous system as the only source of disease
• Concomitant malignancies
• Active known or suspected autoimmune disease
• Uncontrolled or significant cardiovascular disease
• Major surgery less than 4 weeks before the start of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified