Advanced Solid Tumors MedDRA version: 21.1 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: a-CTLA-4 Probody mAb
Product Code: BMS-986249-01
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Anti-CTLA-4 Probody mAb
Current Sponsor code: BMS-986249, BMS-986249-01
MDX1106, ONO-4538
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Trade Name: Opdivo (100 mg/10 ml)
Product Name: NIVOLUMAB - 10ml vial-COMMERCIA
MDX1106, ONO-4538
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Product Name: Ipilimumab
Product Code: BMS-734016
Pharmaceutical Form: Concentr
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 and have at least 1 lesion accessible for biopsy; -Eastern Cooperative Oncology Group Performance Status of 0 or 1; -Some 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; -Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some patients; -Understand and sign an IRB/IEC-approved ICF prior to any study-specific evaluation; -Willing and able to comply with all study procedures. Other protocol defined inclusion criteria could apply. 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 327 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 108
Exclusion criteria
Exclusion criteria: -Participants with primary CNS malignancies, tumors with CNS metastases as the only site of disease or active brain metastases will be excluded; -Active, known, or suspected autoimmune disease; -Participants with other active malignancy requiring concurrent intervention; -Prior organ allograft. Other protocol defined exclusion criteria could apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Parts 1A and 1B: - 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 Part 2A: - To evaluate the preliminary safety and tolerability of BMS-986249 in combination with nivolumab (Arm C and Arm F) relative to ipilimumab in combination with nivolumab (Arm D) in participants with previously untreated, unresectable or metastatic melanoma; _To evaluate the preliminary efficacy of BMS-986249 in combination with nivolumab (Arm C and Arm F) relative to historic nivolumab monotherapy data in participants with previously untreated, unresectable or metastatic melanoma Part 2B: - To evaluate the preliminary safety and tolerability of BMS-986249 in combination with nivolumab in participants with previously treated advanced HCC, CRPC, and TNBC.;Secondary Objective: 1A and 1B: - To characterize the PK of BMS-986249 administered alone and in combination with nivolumab; - To assess the preliminary antitumor activity of BMS-986249 alone and in combination with nivolumab in advanced solid tumors 2A: - To assess the anti-tumor activity and the safety and tolerability of BMS-986249 in combination with nivolumab (Arm C and Arm F) and ipilimumab in combination with nivolumab (Arm D) in participants with previously untreated, unresectable or metastatic melanoma - To characterize the PK of BMS-986249 when administered in combination with nivolumab - To evaluate TTD in Quality of Life (QoL) and physical functioning 2B (previously treated advanced HCC, CRPC, and TNBC): - To assess the preliminary anti-tumor activity of BMS-986249 in combination with nivolumab - To characterize the safety and tolerability of BMS-986249 in combination with nivolumab - To characterize the PK of BMS-986249 when administered in combination with nivolumab;Primary end point(s): _Incidence of AEs, SAEs, death, laboratory abnormalities, treatment-related Gr | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): _Summary measures of PK parameters of BMS-986249; _Summary measures of PK parameters of BMS-986249 in combination with nivolumab; _OOR, DOR, PFS, and TTR per RECIST v1.1 or PCWG3 (for prostate cancer); _Incidence of AEs, SAEs, death, laboratory abnormalities, AEs leading to discontinuation; _TTD.;Timepoint(s) of evaluation of this end point: Up to 2 years and 3 months | — |
Countries
Argentina, Australia, Canada, Chile, Finland, Germany, Italy, Poland, Romania, Spain, United States
Contacts
Public ContactGSM-CT
Bristol-Myers Squibb International Corporation
Outcome results
None listed