Malignant Tumors
Conditions
Keywords
Advanced malignant tumors, Metastatic malignant tumors
Brief summary
The purpose of this study is to assess the safety and tolerability of BMS-663513 in subjects with advanced and/or metastatic malignant tumors.
Interventions
DRUGUrelumab
DRUGNivolumab
Sponsors
Ono Pharmaceutical Co. Ltd
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Subjects with previously treated advanced malignant solid tumor * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 * For certain subjects, willing and able to provide pre-treatment tumor sample
Exclusion criteria
* Known or suspected central nervous system metastases or central nervous system as the only source of disease * Other concomitant malignancies (with some exceptions per protocol) * Active, known or suspected autoimmune disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of urelumab monotherapy as measured by the dose limiting toxicity (DLT) in subjects with advanced and/or metastatic malignant tumors | From day 1 of treatment up to 60 days of follow-up |
| Safety of urelumab monotherapy as measured by adverse events (AEs) and serious adverse events (SAEs) in subjects with advanced and/or metastatic malignant tumors | From day 1 of treatment up to 60 days of follow-up |
| Tolerability of urelumab monotherapy as measured by the DLT in subjects with advanced and/or metastatic malignant tumors | From day 1 of treatment up to 60 days of follow-up |
| Tolerability of urelumab monotherapy as measured by AEs and SAEs in subjects with advanced and/or metastatic malignant tumors | From day 1 of treatment up to 60 days of follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ctrough (Trough observed serum concentration) of urelumab when administered alone | Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up | 21 days/cycle for Urelumab monotherapy |
| Tmax (Time of maximum observed serum concentration) of urelumab when administered alone | Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up | 21 days/cycle for Urelumab monotherapy |
| AUC(0-T) [Area under the concentration-time curve from time zero to the last quantifiable concentration] of urelumab when administered alone | Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up | 21 days/cycle for Urelumab monotherapy |
| AUC(TAU) [Area under the concentration-time curve in one dosing interval] of urelumab when administered alone | Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up | 21 days/cycle for Urelumab monotherapy |
| AUC(INF) [Area under the concentration-time curve from time zero to infinity and the extrapolated area] of urelumab when administered alone | Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up | 21 days/cycle for Urelumab monotherapy |
| T-HALF (Elimination half life) of urelumab when administered alone | Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up | 21 days/cycle for Urelumab monotherapy |
| CLT (Total body clearance) of urelumab when administered alone | Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up | 21 days/cycle for Urelumab monotherapy |
| Vss (Volume of distribution at steady state) of urelumab when administered alone | Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up | 21 days/cycle for Urelumab monotherapy |
| AI (Accumulation Index: ratio of AUC(TAU) and Cmax in cycle at steady state to those after the first cycle) of urelumab when administered alone | Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up | 21 days/cycle for Urelumab monotherapy |
| Cmax of urelumab when co-administered | Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up | 28 days/cycle for combination therapy of Urelumab and Nivolumab |
| Ctrough of urelumab and nivolumab when co-administered | Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up | 28 days/cycle for combination therapy of Urelumab and Nivolumab |
| Coeff of urelumab when co-administered | Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up | 28 days/cycle for combination therapy of Urelumab and Nivolumab |
| AUC(0-T) of urelumab and nivolumab when co-administered | Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up | 28 days/cycle for combination therapy of Urelumab and Nivolumab |
| AUC(TAU) of urelumab and nivolumab when co-administered | Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up | 28 days/cycle for combination therapy of Urelumab and Nivolumab |
| AUC(INF) of urelumab and nivolumab when co-administered | Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up | 28 days/cycle for combination therapy of Urelumab and Nivolumab |
| T-HALF of urelumab when co-administered | Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up | 28 days/cycle for combination therapy of Urelumab and Nivolumab |
| CLT of urelumab when co-administered | Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up | 28 days/cycle for combination therapy of Urelumab and Nivolumab |
| Vss of urelumab when co-administered | Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up | 28 days/cycle for combination therapy of Urelumab and Nivolumab |
| Anti-drug Antibody (ADA) status of the subject in response to Urelumab when administered alone | Cycle 1, 2, 4, 8, 12, 16, up to 60 days of follow up | 21 days/cycle for Urelumab monotherapy |
| ADA status of the subject in response to Urelumab and Nivolumab when co-administered | Cycle 1, 2, 4, 5, 9, up to 100 days of follow up | 28 days/cycle for combination therapy of Urelumab and Nivolumab |
| Best overall response (BOR) of urelumab monotherapy | Every 6-8 weeks during the treatment period | — |
| BOR of urelumab and nivolumab combination therapy | Every 6-8 weeks during the treatment period | — |
| Tmax of urelumab and nivolumab when co-administered | Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up | 28 days/cycle for combination therapy of Urelumab and Nivolumab |
| Safety of urelumab-nivolumab combination therapy as measured by AEs and SAEs in subjects with advanced and/or metastatic malignant tumors | From day 1 of treatment up to 100 days of follow-up | — |
| Tolerability of urelumab-nivolumab combination therapy as measured by AEs and SAEs in subjects with advanced and/or metastatic malignant tumors | From day 1 of treatment up to 100 days of follow-up | — |
| Cmax (Maximum observed serum concentration) of urelumab when administered alone | Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up | 21 days/cycle for Urelumab monotherapy |
Countries
Japan
Outcome results
None listed