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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

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ClinicalTrials.gov Identifier: NCT02253992
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : May 1, 2019
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
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 : March 29, 2019
Actual Study Completion Date : March 29, 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. Safety as measured by the rate of adverse events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 100 days after last dose of treatment ]
    Safety as measured by the rate of adverse events (AEs) and Serious Adverse Events (SAEs), is the primary endpoint of this Phase 1/2 study. All subjects who receive at least one (full or partial) dose of Urelumab or Nivolumab will be evaluated for safety during treatment and for up to 100 days in follow-up


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 ]
  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 ]
  3. Duration of Response (DOR) [ Time Frame: Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years ]
  4. 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 ]
  5. Maximum observed serum concentration (Cmax) of Urelumab,(µg/mL) [ Time Frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days ]
  6. Time of maximum observed serum concentration (Tmax) of Urelumab, (hr) [ Time Frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days ]
  7. Area under the concentration-time curve in one dosing interval (AUCTAU) of Urelumab (µg.hr/mL) [ Time Frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days ]
  8. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUCinf) of Urelumab (µg.hr/mL) [ Time Frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days ]
  9. Total body clearance (CLT) of Urelumab (L/day) [ Time Frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days ]
  10. Volume of distribution at steady state (Vss) of Urelumab [ Time Frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days ]
  11. Half life (t1/2) of Urelumab [ Time Frame: Cycles 1, 2, 3, 4, 6, , and followup Days up to 100 days ]
  12. Trough concentration (Cmin) of Urelumab (µg/mL) [ Time Frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days ]
  13. 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 ]
  14. Anti-drug Antibody (ADA) status of the subject in response to Urelumab and Nivolumab [ Time Frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days ]
  15. Nivolumab end of Infusion concentration (EOI) [ Time Frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days ]
  16. Trough concentration (Cmin) of Nivolumab (µg/mL) [ Time Frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days ]


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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 Cancer Center
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

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02253992     History of Changes
Other Study ID Numbers: CA186-107
2014-002241-22 ( EudraCT Number )
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019

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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
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs