Clinical trial NCT02534506: Study of Urelumab in Subjects With Advanced and/or Metastatic Malignant Tumors
Official title: A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics and Immunoregulatory Activity of Urelumab (BMS-663513) in Subjects With Advanced and/or Metastatic Malignant Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malignant Tumors
Keywords: Advanced malignant tumors
Metastatic malignant tumors
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2015-08-27
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Safety of urelumab monotherapy as measured by the dose limiting toxicity (DLT) in subjects with advanced and/or metastatic malignant tumors
timeFrame: From day 1 of treatment up to 60 days of follow-up
measure: Safety of urelumab monotherapy as measured by adverse events (AEs) and serious adverse events (SAEs) in subjects with advanced and/or metastatic malignant tumors
timeFrame: From day 1 of treatment up to 60 days of follow-up
measure: Tolerability of urelumab monotherapy as measured by the DLT in subjects with advanced and/or metastatic malignant tumors
timeFrame: From day 1 of treatment up to 60 days of follow-up
measure: Tolerability of urelumab monotherapy as measured by AEs and SAEs in subjects with advanced and/or metastatic malignant tumors
timeFrame: From day 1 of treatment up to 60 days of follow-up
Secondary outcomes:
measure: Safety of urelumab-nivolumab combination therapy as measured by AEs and SAEs in subjects with advanced and/or metastatic malignant tumors
timeFrame: From day 1 of treatment up to 100 days of follow-up
measure: Tolerability of urelumab-nivolumab combination therapy as measured by AEs and SAEs in subjects with advanced and/or metastatic malignant tumors
timeFrame: From day 1 of treatment up to 100 days of follow-up
measure: Cmax (Maximum observed serum concentration) of urelumab when administered alone
timeFrame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
measure: Ctrough (Trough observed serum concentration) of urelumab when administered alone
timeFrame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
measure: Tmax (Time of maximum observed serum concentration) of urelumab when administered alone
timeFrame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
measure: AUC(0-T) [Area under the concentration-time curve from time zero to the last quantifiable concentration] of urelumab when administered alone
timeFrame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
measure: AUC(TAU) [Area under the concentration-time curve in one dosing interval] of urelumab when administered alone
timeFrame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
measure: AUC(INF) [Area under the concentration-time curve from time zero to infinity and the extrapolated area] of urelumab when administered alone
timeFrame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
measure: T-HALF (Elimination half life) of urelumab when administered alone
timeFrame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
measure: CLT (Total body clearance) of urelumab when administered alone
timeFrame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
measure: Vss (Volume of distribution at steady state) of urelumab when administered alone
timeFrame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
measure: 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
timeFrame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
measure: Cmax of urelumab when co-administered
timeFrame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
measure: Coeff of urelumab when co-administered
timeFrame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
measure: Ctrough of urelumab and nivolumab when co-administered
timeFrame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
measure: Tmax of urelumab and nivolumab when co-administered
timeFrame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
measure: AUC(0-T) of urelumab and nivolumab when co-administered
timeFrame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
measure: AUC(TAU) of urelumab and nivolumab when co-administered
timeFrame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
measure: AUC(INF) of urelumab and nivolumab when co-administered
timeFrame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
measure: T-HALF of urelumab when co-administered
timeFrame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
measure: CLT of urelumab when co-administered
timeFrame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
measure: Vss of urelumab when co-administered
timeFrame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
measure: Anti-drug Antibody (ADA) status of the subject in response to Urelumab when administered alone
timeFrame: Cycle 1, 2, 4, 8, 12, 16, up to 60 days of follow up
measure: ADA status of the subject in response to Urelumab and Nivolumab when co-administered
timeFrame: Cycle 1, 2, 4, 5, 9, up to 100 days of follow up
measure: Best overall response (BOR) of urelumab monotherapy
timeFrame: Every 6-8 weeks during the treatment period
measure: BOR of urelumab and nivolumab combination therapy
timeFrame: Every 6-8 weeks during the treatment period
Other outcomes:
Locations:
city: Kobe-shi
country: Japan
facility: Local Institution
state: Hyogo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: