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

September 10, 2020 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

232

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France, 25000
        • Local Institution
      • Marseille, France, 13005
        • Local Institution
      • Rennes Cedex 9, France, 35033
        • Local Institution
      • Villejuif, France, 94805
        • Local Institution
  • Germany
      • Essen, Germany, 45147
        • Universitaetsklinikum Essen
  • Spain
      • Pamplona, Spain, 31008
        • Clínica Universidad de Navarra
  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University School of Medicine
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Maryland
      • Lutherville, Maryland, United States, 21093
        • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Medical Center
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Nassau
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation and Cohort expansion: Urelumab + Nivolumab

Nivolumab followed by Urelumab

Nivolumab every 2 weeks up to 12 cycles and Urelumab every 4 weeks up to 6 cycles
Biological: Nivolumab
Other Names:
  • BMS-936558
Biological: Urelumab
Other Names:
  • BMS-663513

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Incidence of Adverse Events.
Time Frame: From day 1 until 100 days after participant last dose of study drug.
From day 1 until 100 days after participant last dose of study drug.
The Incidence of Seriuos Adverse Events.
Time Frame: From day 1 until 100 days after participant last dose of the study drug.
From day 1 until 100 days after participant last dose of the study drug.
The Incidence of Death.
Time Frame: From day 1 until 100 days after participant last dose of study drug.
From day 1 until 100 days after participant last dose of study drug.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Overall Response (BOR)
Time Frame: Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.
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.
Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.
Objective Response Rate (ORR)
Time Frame: Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.
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.
Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.
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.
Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Duration of Response (DOR)
Time Frame: Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years

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.
Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years
Progression-free Survival Rate (PFSR)
Time Frame: Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.

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.
Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.
Maximum Observed Serum Concentration (Cmax)
Time Frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Data was not collected due to discontinuation of the study/Due to study termination.
Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Time of Maximum Observed Serum Concentration (Tmax)
Time Frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Data was not collected due to discontinuation of the study/Due to study termination.
Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Area Under the Concentration-time Curve in One Dosing Interval (AUCTAU)
Time Frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days
Data was not collected due to discontinuation of the study/Due to study termination.
Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days
Trough Observed Plasma Concentration(Ctrough)
Time Frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Data was not collected due to discontinuation of the study/Due to study termination.
Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
End of Infusion Concentration (Ceoinf)
Time Frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Data was not collected due to discontinuation of the study/Due to study termination.
Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Area Under the Plasma Concentration-time Curve, 0 to Time of Last Quantifiable Concentration (AUC(0-T)
Time Frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Data was not collected due to discontinuation of the study/Due to study termination.
Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2014

Primary Completion (Actual)

May 24, 2019

Study Completion (Actual)

May 24, 2019

Study Registration Dates

First Submitted

September 29, 2014

First Submitted That Met QC Criteria

September 29, 2014

First Posted (Estimate)

October 1, 2014

Study Record Updates

Last Update Posted (Actual)

October 5, 2020

Last Update Submitted That Met QC Criteria

September 10, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA186-107
  • 2014-002241-22 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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