search
Back to results

An Investigational Immuno-therapy Study to Determine the Safety of Urelumab Given in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkin's Lymphoma

Primary Purpose

Advanced Solid Tumors, Advanced B-cell NHL

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Urelumab
Nivolumab
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • For Dose Escalation:

    • Subjects with any previously treated advanced (metastatic or refractory) solid tumor type and B-cell non-Hodgkin lymphoma

  • For Cohort Expansion:

    • Subjects must have a previously treated advanced solid tumor or B cell non-Hodgkin's lymphoma to be eligible
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    • For certain subjects, willing and able to provide pre-treatment and on-treatment fresh tumor biopsy
    • Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men

Exclusion Criteria:

  • Known 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
  • Uncontrolled or significant cardiovascular disease
  • History of hepatitis (B or C)
  • History of active or latent tuberculosis

Sites / Locations

  • Stanford University School Of Medicine
  • H. Lee Moffitt Cancer Center
  • University Of Chicago
  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
  • Dana Farber Cancer Institute
  • Dana-Farber Cancer Institute
  • NYU Langone Medical Center
  • Memorial Sloan Kettering Nassau
  • Providence Portland Medical Center
  • UPMC Cancer Center
  • Md Anderson
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Universitaetsklinikum Essen
  • Clinica Universidad de Navarra

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dose Escalation and Cohort expansion: Urelumab + Nivolumab

Arm Description

Nivolumab followed by Urelumab Nivolumab every 2 weeks up to 12 cycles and Urelumab every 4 weeks up to 6 cycles

Outcomes

Primary Outcome Measures

The Incidence of Adverse Events.
The Incidence of Seriuos Adverse Events.
The Incidence of Death.

Secondary Outcome Measures

Best Overall Response (BOR)
The total number of subjects whose best overall response (BOR) is either a complete response or partial response for solid tumors and complete remission or partial remission for B-cell NHL, divided by the total number of subjects in the population of interest.
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the total number of subjects whose BOR is either CR or PR divided by the total number of subjects in the population of interest.
Occurrence of Specific Anti-drug Antibodies (ADA) to Urelumab and Nivolumab
Duration of Response (DOR)
DOR is defined as the number of days between the date of first response and the subsequent date of objectively documented disease progression based on the criteria (RECIST v1.1) or relapse based on IWG, or death due to any cause, if death occurred within 100 days after last dose, whichever occurs first. Data was not collected due to discontinuation of the study/Due to study termination.
Progression-free Survival Rate (PFSR)
PFSR is defined as the probability of a subject remaining progression-free and surviving a specific length of time. Data was not collected due to discontinuation of the study/Due to study termination.
Maximum Observed Serum Concentration (Cmax)
Data was not collected due to discontinuation of the study/Due to study termination.
Time of Maximum Observed Serum Concentration (Tmax)
Data was not collected due to discontinuation of the study/Due to study termination.
Area Under the Concentration-time Curve in One Dosing Interval (AUCTAU)
Data was not collected due to discontinuation of the study/Due to study termination.
Trough Observed Plasma Concentration(Ctrough)
Data was not collected due to discontinuation of the study/Due to study termination.
End of Infusion Concentration (Ceoinf)
Data was not collected due to discontinuation of the study/Due to study termination.
Area Under the Plasma Concentration-time Curve, 0 to Time of Last Quantifiable Concentration (AUC(0-T)
Data was not collected due to discontinuation of the study/Due to study termination.

Full Information

First Posted
September 29, 2014
Last Updated
September 10, 2020
Sponsor
Bristol-Myers Squibb
search

1. Study Identification

Unique Protocol Identification Number
NCT02253992
Brief Title
An Investigational Immuno-therapy Study to Determine the Safety of Urelumab Given in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkin's Lymphoma
Official Title
A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety and Tolerability of Urelumab Administered in Combination With Nivolumab in Advanced/Metastatic Solid Tumors and B-cell Non-Hodgkins Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Study Start Date
September 29, 2014 (Actual)
Primary Completion Date
May 24, 2019 (Actual)
Study Completion Date
May 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine which doses of Urelumab and Nivolumab are safe and tolerable when they are given together.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumors, Advanced B-cell NHL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
232 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation and Cohort expansion: Urelumab + Nivolumab
Arm Type
Experimental
Arm Description
Nivolumab followed by Urelumab Nivolumab every 2 weeks up to 12 cycles and Urelumab every 4 weeks up to 6 cycles
Intervention Type
Biological
Intervention Name(s)
Urelumab
Other Intervention Name(s)
BMS-663513
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
BMS-936558
Primary Outcome Measure Information:
Title
The Incidence of Adverse Events.
Time Frame
From day 1 until 100 days after participant last dose of study drug.
Title
The Incidence of Seriuos Adverse Events.
Time Frame
From day 1 until 100 days after participant last dose of the study drug.
Title
The Incidence of Death.
Time Frame
From day 1 until 100 days after participant last dose of study drug.
Secondary Outcome Measure Information:
Title
Best Overall Response (BOR)
Description
The total number of subjects whose best overall response (BOR) is either a complete response or partial response for solid tumors and complete remission or partial remission for B-cell NHL, divided by the total number of subjects in the population of interest.
Time Frame
Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.
Title
Objective Response Rate (ORR)
Description
Objective response rate (ORR) is defined as the total number of subjects whose BOR is either CR or PR divided by the total number of subjects in the population of interest.
Time Frame
Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.
Title
Occurrence of Specific Anti-drug Antibodies (ADA) to Urelumab and Nivolumab
Time Frame
Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Title
Duration of Response (DOR)
Description
DOR is defined as the number of days between the date of first response and the subsequent date of objectively documented disease progression based on the criteria (RECIST v1.1) or relapse based on IWG, or death due to any cause, if death occurred within 100 days after last dose, whichever occurs first. Data was not collected due to discontinuation of the study/Due to study termination.
Time Frame
Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years
Title
Progression-free Survival Rate (PFSR)
Description
PFSR is defined as the probability of a subject remaining progression-free and surviving a specific length of time. Data was not collected due to discontinuation of the study/Due to study termination.
Time Frame
Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.
Title
Maximum Observed Serum Concentration (Cmax)
Description
Data was not collected due to discontinuation of the study/Due to study termination.
Time Frame
Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Title
Time of Maximum Observed Serum Concentration (Tmax)
Description
Data was not collected due to discontinuation of the study/Due to study termination.
Time Frame
Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Title
Area Under the Concentration-time Curve in One Dosing Interval (AUCTAU)
Description
Data was not collected due to discontinuation of the study/Due to study termination.
Time Frame
Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days
Title
Trough Observed Plasma Concentration(Ctrough)
Description
Data was not collected due to discontinuation of the study/Due to study termination.
Time Frame
Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Title
End of Infusion Concentration (Ceoinf)
Description
Data was not collected due to discontinuation of the study/Due to study termination.
Time Frame
Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Title
Area Under the Plasma Concentration-time Curve, 0 to Time of Last Quantifiable Concentration (AUC(0-T)
Description
Data was not collected due to discontinuation of the study/Due to study termination.
Time Frame
Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: For Dose Escalation: Subjects with any previously treated advanced (metastatic or refractory) solid tumor type and B-cell non-Hodgkin lymphoma For Cohort Expansion: Subjects must have a previously treated advanced solid tumor or B cell non-Hodgkin's lymphoma to be eligible Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 For certain subjects, willing and able to provide pre-treatment and on-treatment fresh tumor biopsy Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men Exclusion Criteria: Known 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 Uncontrolled or significant cardiovascular disease History of hepatitis (B or C) History of active or latent tuberculosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University School Of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University Of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan Kettering Nassau
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
UPMC Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Md Anderson
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Local Institution
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
Local Institution
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Local Institution
City
Rennes Cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
Local Institution
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Clinica Universidad de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

An Investigational Immuno-therapy Study to Determine the Safety of Urelumab Given in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkin's Lymphoma

We'll reach out to this number within 24 hrs