An Investigational Immuno-Therapy Study of Experimental Medication BMS-986253 Given in Combination with Nivolumab in Patients with Advanced Cancers
- Conditions
- Advanced CancersMedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-000340-26-IT
- Lead Sponsor
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 800
- Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with
measurable disease per RECIST v1.1
- At least 1 lesion accessible for biopsy
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
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 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400
- Participants with primary central nervous system (CNS) tumors, or with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)
- Participants with active, known or suspected autoimmune disease
- Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
- Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)
- Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
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 RP2D of BMS-986253 administered in combination with nivolumab in participants with advanced solid tumors.;Secondary Objective: To evaluate the preliminary efficacy of BMS-986253 in combination with nivolumab in participants with advanced solid tumors using RECIST v1.1.<br><br>To characterize the PK and immunogenicity of BMS-986253 when administered in combination with nivolumab in participants with advanced solid tumors.<br><br>To assess serum IL-8 levels at baseline (ie,screening) and changes in IL-8 levels on-treatment.;Primary end point(s): Incidence of adverse events (AE)<br>Incidence of serious adverse events (SAE)<br>Incidence of AEs meeting protocol defined dose limiting toxicities (DLT) criteria<br>Incidence of AEs leading to discontinuation<br>Incidence of deaths<br>Incidence of laboratory abnormalities;Timepoint(s) of evaluation of this end point: Approximately 5 years
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Overall response rate (ORR)<br>Median duration of response (mDOR)<br>Incidence of anti-drug antibody (ADA) to BMS-986253<br>Serum biomarker concentration<br>Maximum observed serum concentration (Cmax)<br>Time of maximum observed serum concentration (Tmax)<br>Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]<br>Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]<br>Observed serum concentration at the end of a dosing interval (Ctau)<br>Trough observed serum concentration at the end of the dosing interval (Ctrough)<br>;Timepoint(s) of evaluation of this end point: Approximately 5 years