Advanced Cancers MedDRA version: 21.1 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 100000004864
Conditions
Interventions
Product Name: Anti-IL-8
Product Code: BMS-986253
Pharmaceutical Form: Solution for injection
INN or Proposed INN: IL8
Current Sponsor co
Anti-HuMax-IL8
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
Trade Name: OPDIVO
Anti-HuMax-IL8
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. To characterize the PK and immunogenicity of BMS-986253 when administered in combination with nivolumab in participants with advanced solid tumors. 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) Incidence of serious adverse events (SAE) Incidence of AEs meeting protocol defined dose limiting toxicities (DLT) criteria Incidence of AEs leading to discontinuation Incidence of deaths Incidence of laboratory abnormalities ;Timepoint(s) of evaluation of this end point: Approximately 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Approximately 5 years; Secondary end point(s): Overall response rate (ORR) Median duration of response (mDOR) Incidence of anti-drug antibody (ADA) to BMS-986253 Serum biomarker concentration Maximum observed serum concentration (Cmax) Time of maximum observed serum concentration (Tmax) Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] Observed serum concentration at the end of a dosing interval (Ctau) Trough observed serum concentration at the end of the dosing interval (Ctrough) | — |
Countries
Belgium, Canada, Finland, Germany, Norway, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
Public ContactGCT-SU
Bristol-Myers Squibb International Corporation
Outcome results
None listed