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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02253992
Recruitment Status : Terminated
First Posted : October 1, 2014
Results First Posted : October 5, 2020
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Advanced B-cell NHL Biological: Urelumab Biological: Nivolumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 232 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 29, 2014
Actual Primary Completion Date : May 24, 2019
Actual Study Completion Date : May 24, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Nivolumab

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: Urelumab
Other Name: BMS-663513

Biological: Nivolumab
Other Name: BMS-936558




Primary Outcome Measures :
  1. The Incidence of Adverse Events. [ Time Frame: From day 1 until 100 days after participant last dose of study drug. ]
  2. The Incidence of Seriuos Adverse Events. [ Time Frame: From day 1 until 100 days after participant last dose of the study drug. ]
  3. The Incidence of Death. [ Time Frame: From day 1 until 100 days after participant last dose of study drug. ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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. ]
  4. 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.


  5. 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.


  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02253992


Locations
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United States, California
Stanford University School Of Medicine
Palo Alto, California, United States, 94304
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Illinois
University Of Chicago
Chicago, Illinois, United States, 60637
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Lutherville, Maryland, United States, 21093
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
Memorial Sloan Kettering Nassau
New York, New York, United States, 10065
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Pennsylvania
UPMC Cancer Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Md Anderson
Houston, Texas, United States, 77030
France
Local Institution
Besancon, France, 25000
Local Institution
Marseille, France, 13005
Local Institution
Rennes Cedex 9, France, 35033
Local Institution
Villejuif, France, 94805
Germany
Universitaetsklinikum Essen
Essen, Germany, 45147
Spain
Clinica Universidad de Navarra
Pamplona, Spain, 31008
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Statistical Analysis Plan  [PDF] July 18, 2016
Study Protocol  [PDF] March 22, 2017

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02253992    
Other Study ID Numbers: CA186-107
2014-002241-22 ( EudraCT Number )
First Posted: October 1, 2014    Key Record Dates
Results First Posted: October 5, 2020
Last Update Posted: October 5, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents