EUCTR2017-000597-11-BEActive, not recruitingPhase 1
Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone and in Combination with Nivolumab in Advanced Solid Tumors.
Bristol-Myers Squibb International Corporation0 sites600 target enrollmentStarted: July 23, 2020Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 600
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •_Participants must be at least 18 years old;
- •_have histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1 (Appendix 5) or per PCWG 3 criteria for prostate (Appendix 12);
- •_have at least one soft-tissue lesion accessible for biopsy;
- •_Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the start of study treatment;
- •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 360
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 240
Exclusion Criteria
- •_Participants with primary CNS malignancies, or tumors with CNS metastases as the only site of disease, will be excluded.
Investigators
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