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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

This study is currently recruiting participants.
Verified November 2017 by Bristol-Myers Squibb
Sponsor:
ClinicalTrials.gov Identifier:
NCT02253992
First Posted: October 1, 2014
Last Update Posted: November 17, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
September 29, 2014
October 1, 2014
November 17, 2017
September 29, 2014
December 26, 2018   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT02253992 on ClinicalTrials.gov Archive Site
  • Best Overall Response (BOR) [ Time Frame: 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 ]
  • Duration of Response (DOR) [ Time Frame: 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 ]
  • Maximum observed serum concentration (Cmax) of Urelumab,(µg/mL) [ Time Frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Total body clearance (CLT) of Urelumab (L/day) [ Time Frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days ]
  • Volume of distribution at steady state (Vss) of Urelumab [ Time Frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days ]
  • Half life (t1/2) of Urelumab [ Time Frame: Cycles 1, 2, 3, 4, 6, , and followup Days up to 100 days ]
  • Trough concentration (Cmin) of Urelumab (µg/mL) [ Time Frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days ]
  • 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 ]
  • 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 ]
  • Nivolumab end of Infusion concentration (EOI) [ Time Frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days ]
  • Trough concentration (Cmin) of Nivolumab (µg/mL) [ Time Frame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days ]
  • Best Overall Response (BOR) [ Time Frame: Every 8 weeks for Cycle 1 through Cycle 12 then every 12 weeks thereafter for approximately 2 years ]
  • Objective response rate (ORR) [ Time Frame: Every 8 weeks for Cycle 1 through Cycle 12 then every 12 weeks thereafter for approximately 2 years ]
  • Duration of Response (DOR) [ Time Frame: Every 8 weeks for Cycle 1 through Cycle 12 then every 12 weeks thereafter for approximately 2 years ]
  • Progression-free survival rate (PFSR) [ Time Frame: Every 8 weeks for Cycle 1 through Cycle 12 then every 12 weeks thereafter for approximately 2 years ]
  • Maximum observed serum concentration (Cmax) of Urelumab,(µg/mL) [ Time Frame: Cycles 1, 2, 3, 4, 6, 8, 10, 12, and followup Days up to 100 days ]
  • Time of maximum observed serum concentration (Tmax) of Urelumab, (hr) [ Time Frame: Cycles 1, 2, 3, 4, 6, 8, 10, 12, and followup Days up to 100 days ]
  • Area under the concentration-time curve in one dosing interval (AUCTAU) of Urelumab (µg.hr/mL) [ Time Frame: Cycles 1, 2, 3, 4, 6, 8, 10, 12, and followup Days up to 100 days ]
  • 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, 8, 10, 12, and followup Days up to 100 days ]
  • Total body clearance (CLT) of Urelumab (L/day) [ Time Frame: Cycles 1, 2, 3, 4, 6, 8, 10, 12, and followup Days up to 100 days ]
  • Volume of distribution at steady state (Vss) of Urelumab [ Time Frame: Cycles 1, 2, 3, 4, 6, 8, 10, 12, and followup Days up to 100 days ]
  • Half life (t1/2) of Urelumab [ Time Frame: Cycles 1, 2, 3, 4, 6, 8, 10, 12, and followup Days up to 100 days ]
  • Trough concentration (Cmin) of Urelumab (µg/mL) [ Time Frame: Cycles 1, 2, 3, 4, 6, 8, 10, 12, and followup Days up to 100 days ]
  • Occurrence of specific anti-drug antibodies (ADA) to Urelumab and Nivolumab [ Time Frame: Cycles 1, 2, 3, 4, 6, 8, 10, 12, and followup Days up to 100 days ]
  • Anti-drug Antibody (ADA) status of the subject in response to Urelumab and Nivolumab [ Time Frame: Cycles 1, 2, 3, 4, 6, 8, 10, 12, and followup Days up to 100 days ]
  • Nivolumab end of Infusion concentration (EOI) [ Time Frame: Cycles 1, 2, 3, 4, 6, 8, 10, 12, and followup Days up to 100 days ]
  • Trough concentration (Cmin) of Nivolumab (µg/mL) [ Time Frame: Cycles 1, 2, 3, 4, 6, 8, 10, 12, and followup Days up to 100 days ]
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Advanced Solid Tumors
  • Advanced B-cell NHL
  • Biological: Urelumab
    Other Name: BMS-663513
  • Biological: Nivolumab
    Other Name: BMS-936558
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

Interventions:
  • Biological: Urelumab
  • Biological: Nivolumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
September 27, 2019
December 26, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.
France,   Germany,   Spain,   United States
 
 
NCT02253992
CA186-107
2014-002241-22 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP