Study of Urelumab in Subjects With Advanced and/or Metastatic Malignant Tumors

Malignant Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02534506
• Other study ID #: CA186-110
• Status: Completed
• Phase: Phase 1
• Start date: November 6, 2015
• Est. completion date: November 11, 2016

Study information

• Verified date: May 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 11, 2016
• Est. primary completion date: November 11, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Tumors
• Neoplasms

Intervention

Drug:
• Urelumab

• Nivolumab

Locations

Country	Name	City	State
Japan	Local Institution	Kobe-shi	Hyogo

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Cmax (Maximum observed serum concentration) of urelumab when administered alone	21 days/cycle for Urelumab monotherapy	Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
Secondary	Ctrough (Trough observed serum concentration) of urelumab when administered alone	21 days/cycle for Urelumab monotherapy	Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
Secondary	Tmax (Time of maximum observed serum concentration) of urelumab when administered alone	21 days/cycle for Urelumab monotherapy	Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
Secondary	AUC(0-T) [Area under the concentration-time curve from time zero to the last quantifiable concentration] of urelumab when administered alone	21 days/cycle for Urelumab monotherapy	Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
Secondary	AUC(TAU) [Area under the concentration-time curve in one dosing interval] of urelumab when administered alone	21 days/cycle for Urelumab monotherapy	Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
Secondary	AUC(INF) [Area under the concentration-time curve from time zero to infinity and the extrapolated area] of urelumab when administered alone	21 days/cycle for Urelumab monotherapy	Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
Secondary	T-HALF (Elimination half life) of urelumab when administered alone	21 days/cycle for Urelumab monotherapy	Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
Secondary	CLT (Total body clearance) of urelumab when administered alone	21 days/cycle for Urelumab monotherapy	Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
Secondary	Vss (Volume of distribution at steady state) of urelumab when administered alone	21 days/cycle for Urelumab monotherapy	Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
Secondary	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	21 days/cycle for Urelumab monotherapy	Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up
Secondary	Cmax of urelumab when co-administered	28 days/cycle for combination therapy of Urelumab and Nivolumab	Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
Secondary	Coeff of urelumab when co-administered	28 days/cycle for combination therapy of Urelumab and Nivolumab	Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
Secondary	Ctrough of urelumab and nivolumab when co-administered	28 days/cycle for combination therapy of Urelumab and Nivolumab	Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
Secondary	Tmax of urelumab and nivolumab when co-administered	28 days/cycle for combination therapy of Urelumab and Nivolumab	Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
Secondary	AUC(0-T) of urelumab and nivolumab when co-administered	28 days/cycle for combination therapy of Urelumab and Nivolumab	Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
Secondary	AUC(TAU) of urelumab and nivolumab when co-administered	28 days/cycle for combination therapy of Urelumab and Nivolumab	Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
Secondary	AUC(INF) of urelumab and nivolumab when co-administered	28 days/cycle for combination therapy of Urelumab and Nivolumab	Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
Secondary	T-HALF of urelumab when co-administered	28 days/cycle for combination therapy of Urelumab and Nivolumab	Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
Secondary	CLT of urelumab when co-administered	28 days/cycle for combination therapy of Urelumab and Nivolumab	Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
Secondary	Vss of urelumab when co-administered	28 days/cycle for combination therapy of Urelumab and Nivolumab	Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up
Secondary	Anti-drug Antibody (ADA) status of the subject in response to Urelumab when administered alone	21 days/cycle for Urelumab monotherapy	Cycle 1, 2, 4, 8, 12, 16, up to 60 days of follow up
Secondary	ADA status of the subject in response to Urelumab and Nivolumab when co-administered	28 days/cycle for combination therapy of Urelumab and Nivolumab	Cycle 1, 2, 4, 5, 9, up to 100 days of follow up
Secondary	Best overall response (BOR) of urelumab monotherapy		Every 6-8 weeks during the treatment period
Secondary	BOR of urelumab and nivolumab combination therapy		Every 6-8 weeks during the treatment period

External Links

•   BMS Clinical Trial Patient Recruiting
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