Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone and in Combination with Nivolumab in Advanced Solid Tumors.

Phase 1

Conditions: Advanced Solid Tumors
MedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2017-000597-11-NO

Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: _To characterize the safety, tolerability, and DLTs and to determine the MTD/RP2D of BMS-986218 administered as monotherapy and in combination with nivolumab in participants with advanced solid tumors;<br>_To evaluate the efficacy and safety of BMS-986218 monotherapy relative to ipilimumab in participants with advanced cutaneous melanoma previously treated with anti-PD-1/PD-L1 immunotherapy.;Secondary Objective: _To evaluate the preliminary efficacy of BMS-986218 alone and in combination with nivolumab in advanced solid tumors;<br>_To characterize the PK and immunogenicity of BMS-986218 when administered alone and in combination with nivolumab;<br>;Primary end point(s): _Incidence of AEs, SAEs, AEs meeting protocol-defined DLT criteria, AEs leading<br>to discontinuation, death, and laboratory abnormalities<br>_ORR, mDOR, and PFSR at 24, 36, and 48 weeks by RECIST v1.1;Timepoint(s) of evaluation of this end point: _24, 36, and 48 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): _ORR, mDOR, and PFSR at 24, 36, and 48 weeks by RECIST v1.1<br>_Summary measures of PK parameters and incidence of ADA to BMS-986218<br>;Timepoint(s) of evaluation of this end point: at 24, 36, and 48 weeks