Phase 1 Study of Urelumab in Subjects With Advanced and/or Metastatic Malignant Tumors

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

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223015

Enrollment

Registered

2015-11-13

Start date

2015-11-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Tumors

Interventions

investigational material(s) Generic name etc : Urelumab (BMS-663513) INN of investigational material : Urelumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Inv

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Previously treated advanced malignant solid tumor Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1 For certain subjects, willing and able to provide pre-treatment tumor sample

Exclusion criteria

Exclusion criteria: Known or suspected central nervous system metastases or central nervous system as the only source of disease Prior malignancy (with some exceptions per protocol) Active, known or suspected autoimmune disease

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of urelumab monotherapy Measured by the DLT, AEs and SAEs	—

Secondary

Measure	Time frame
Safety and tolerability of urelumab-nivolumab combination therapy PK of urelumab under urelumab monotherapy and urelumab-nivolumab combination therapy PK of nivolumab under urelumab-nivolumab combination therapy Immunogenicity of urelumab under urelumab monotherapy and urelumab-nivolumab combination therapy Immunogenicity of nivolumab underurelumab-nivolumab combination therapy Preliminary anti-tumor activity of urelumab monotherapy and urelumab-nivolumab combination therapy Measured by AEs and SAEs The following PK parameters for urelumab when administered as monotherapy: Cmax, Ctrough, Tmax, AUC(0-T), AUC(TAU), AUC(INF), T-HALF, CLT, Vss and AI. The following PK parameters for urelumab and/or nivolumab when administered as combination therapy: Cmax, Ctrough, Tmax, AUC(0-T), AUC(TAU), AUC(INF), T-HALF, CLT and Vss. ADA status in response to urelumab monotherapy and urelumab-nivolumab combination therapy. Investigator assessed best overall response	—

Measure

Time frame

Safety and tolerability of urelumab-nivolumab combination therapy PK of urelumab under urelumab monotherapy and urelumab-nivolumab combination therapy PK of nivolumab under urelumab-nivolumab combination therapy Immunogenicity of urelumab under urelumab monotherapy and urelumab-nivolumab combination therapy Immunogenicity of nivolumab underurelumab-nivolumab combination therapy Preliminary anti-tumor activity of urelumab monotherapy and urelumab-nivolumab combination therapy Measured by AEs and SAEs The following PK parameters for urelumab when administered as monotherapy: Cmax, Ctrough, Tmax, AUC(0-T), AUC(TAU), AUC(INF), T-HALF, CLT, Vss and AI. The following PK parameters for urelumab and/or nivolumab when administered as combination therapy: Cmax, Ctrough, Tmax, AUC(0-T), AUC(TAU), AUC(INF), T-HALF, CLT and Vss. ADA status in response to urelumab monotherapy and urelumab-nivolumab combination therapy. Investigator assessed best overall response

—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026