Study of BMS-986178 Monotherapy or in Combination With Nivolumab and/or Ipilimumab in Subjects With Advanced Solid Tumors.
- Conditions
- Advanced Solid TumorsMedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-004816-39-NL
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 166
• Subjects must be refractory to or intolerant of established therapy known to provide clinical benefit for their condition, i.e., subjects must not be candidates for regimens known to provide clinical benefit
• 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 247
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 357
• 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method