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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000597-11-DE

Enrollment

600

Registered

2019-07-24

Start date

2019-12-17

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors MedDRA version: 21.1 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 100000004864

Interventions

Product Name: anti-CTLA4-NF mAb Product Code: BMS-986218 Pharmaceutical Form: Solution for injection INN or Proposed INN: BMS-986218 Other descriptive name: BMS986218, BMS-986218-01 Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: _Participants with primary CNS malignancies, or tumors with CNS metastases as the only site of disease, will be excluded.

Design outcomes

Primary

Measure	Time frame
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; _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 (Part 2A only) - To evaluate the efficacy and safety of BMS-986218 alone and in combination with nivolumab in NSCLC (Part 2B and Part 2C) _To evaluate the efficacy and safety of BMS-986218 alone and in combination with nivolumab in MSS CRC (Part 2D);Secondary Objective: _To evaluate the preliminary efficacy of BMS-986218 alone and in combination with nivolumab in advanced solid tumors (Part 1A and Part 1B); _To characterize the PK and immunogenicity of BMS-986218 when administered alone and in combination with nivolumab; ;Primary end point(s): _Incidence of AEs, SAEs, AEs meeting protocol-defined DLT criteria, AEs leading to discontinuation and death _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	—

Measure

Time frame

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; _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 (Part 2A only) - To evaluate the efficacy and safety of BMS-986218 alone and in combination with nivolumab in NSCLC (Part 2B and Part 2C) _To evaluate the efficacy and safety of BMS-986218 alone and in combination with nivolumab in MSS CRC (Part 2D);Secondary Objective: _To evaluate the preliminary efficacy of BMS-986218 alone and in combination with nivolumab in advanced solid tumors (Part 1A and Part 1B); _To characterize the PK and immunogenicity of BMS-986218 when administered alone and in combination with nivolumab; ;Primary end point(s): _Incidence of AEs, SAEs, AEs meeting protocol-defined DLT criteria, AEs leading to discontinuation and death _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

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

Countries

Argentina, Australia, Belgium, Canada, Chile, Denmark, Finland, France, Germany, Israel, Italy, Netherlands, Norway, Poland, Romania, Spain, Switzerland, United States

Contacts

Public ContactGSM-CT

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026