A Phase I/2a study of BMS-986156 given alone and in combination with nivolumab in subjects with advanced solid tumors.
- Conditions
- Advanced Solid TumorsMedDRA version: 20.0Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-002505-11-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
- 380
For Dose Escalation:
- Subjects with any previously treated advanced (metastatic or refractory) solid tumor
For Cohort Expansion:
- Subjects must have a previously treated advanced solid tumor to be eligible
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Willing and able to provide pre-treatment and on-treatment fresh tumor biopsy
- Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men
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 304
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 76
- Known central nervous system metastases or central nervous system as the only source of disease
- Other concomitant malignancies (with some exceptions per protocol)
- Active, known or suspected autoimmune disease
- Uncontrolled or significant cardiovascular disease
- History of chronic hepatitis
- History of active hepatitis (B or C)
- Impaired liver or bone marrow function
- Major surgery less than 1 month before 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