NCT02534506

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 27, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

November 6, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2016

Completed
Last Updated

May 18, 2020

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

August 5, 2015

Last Update Submit

May 14, 2020

Conditions

Malignant Tumors

Keywords

Advanced malignant tumorsMetastatic malignant tumors

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (26)

  • 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

  • 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

  • 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 more secondary outcomes

Study Arms (1)

Urelumab (+ Nivolumab) intravenous (IV) infusion

EXPERIMENTAL
Drug: UrelumabDrug: Nivolumab

Interventions

UrelumabDRUG
Urelumab (+ Nivolumab) intravenous (IV) infusion
NivolumabDRUG
Urelumab (+ Nivolumab) intravenous (IV) infusion

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Kobe, Hyōgo, 6500017, Japan

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

urelumabNivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2015

First Posted

August 27, 2015

Study Start

November 6, 2015

Primary Completion

November 11, 2016

Study Completion

November 11, 2016

Last Updated

May 18, 2020

Record last verified: 2020-05

Locations

JP(1)