A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination with Nivolumab in Advanced Solid Tumors

Phase 1

• Conditions: Advanced Solid Tumors; MedDRA version: 20.0Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-000416-21-ES
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-10
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 300

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
_Have at least 1 lesion accessible for biopsy;
_Eastern Cooperative Oncology Group Performance Status of 0 or 1;
_Participants must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to solid tumor histologies.
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 225
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

_Participants with primary CNS malignancies or tumors with CNS metastases as the only site of disease;
_Participants with other active malignancy requiring concurrent intervention;

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-986249 administered as monotherapy and in combination with nivolumab in participants with advanced solid tumors (Parts 1A and 1B).;Secondary Objective: _To characterize the PK of BMS-986249 when administered alone and in combination with nivolumab;<br>_To assess the preliminary efficacy of BMS-986249 alone and in combination with nivolumab in advanced solid tumors (Parts 1A and 1B) using RECIST v1.1 or PCWG3 (for prostate cancer).;Primary end point(s): _Incidence of AEs, SAEs, AEs meeting protocol-defined DLT criteria, _AEs leading to discontinuation, death, and laboratory abnormalities;Timepoint(s) of evaluation of this end point: Up to 4 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): _Summary measures of PK parameters of BMS-986249 up to 2 years;<br>_BOR, DOR, PFS, and TTR per RECIST v1.1 or PCWG3 (for prostate cancer) up to 4 years;Timepoint(s) of evaluation of this end point: Up to 2 years or up to 4 years