Study of Urelumab in Subjects With Advanced and/or Metastatic Malignant Tumors
- Registration Number
- NCT02534506
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Urelumab (+ Nivolumab) intravenous (IV) infusion Urelumab - Urelumab (+ Nivolumab) intravenous (IV) infusion Nivolumab -
- Primary Outcome Measures
Name Time Method 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 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 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 Outcome Measures
Name Time Method 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
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
BOR of urelumab and nivolumab combination therapy Every 6-8 weeks during the treatment period 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
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
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
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
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 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
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
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 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
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
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
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
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
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
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
Trial Locations
- Locations (1)
Local Institution
🇯🇵Kobe-shi, Hyogo, Japan