Try our beta test site

Study of the Safety and Tolerability of Urelumab Administered in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkins Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02253992
First received: September 29, 2014
Last updated: March 3, 2017
Last verified: August 2016
  Purpose
The purpose of this study is to determine which doses of Urelumab and Nivolumab are safe and tolerable when they are given together.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: September 2014
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02253992

Contacts
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 #.

Locations
United States, California
Stanford University School Of Medicine Recruiting
Palo Alto, California, United States, 94304
Contact: Shivaani Kummar, Site 0016    650-498-8604      
United States, Florida
H. Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Nikhil Khushalani, Site 0001    813-745-4617      
United States, Illinois
University Of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Jason Luke, Site 0017         
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Recruiting
Lutherville, Maryland, United States, 21093
Contact: William Sharfman, Site 0006         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Patrick Ott, Site 0009    617-724-4000      
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Patrick Ott, Site 0015    617-632-9285      
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Patrick A. Ott, Site 0005    617-632-5055      
United States, New York
Nyu Langone Medical Center Recruiting
New York, New York, United States, 10016
Contact: Jeffrey Weber, Site 0020    212-263-4428      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Neil Segal, Site 0007    646-888-3359      
United States, Oregon
Providence Portland Medical Center Active, not recruiting
Portland, Oregon, United States, 97213
United States, Pennsylvania
Upmc Eye And Ear Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Robert Ferris, Site 0003    412-623-7957      
United States, Texas
Md Anderson Recruiting
Houston, Texas, United States, 77030
Contact: Vassiliki Papadimitrakopoulou, Site 0002    713-792-6363      
France
Local Institution Recruiting
Besancon, France, 25000
Contact: Site 0014         
Local Institution Recruiting
Marseille, France, 13005
Contact: Site 0013         
Local Institution Recruiting
Rennes Cedex 9, France, 35033
Contact: Site 0012         
Local Institution Recruiting
Villejuif, France, 94805
Contact: Site 0011         
Germany
Universitaetsklinikum Essen Recruiting
Essen, Germany, 45147
Contact: Dirk Schadendorf, Site 0008    +492017234342      
Spain
Local Institution Recruiting
Pamplona, Spain, 31008
Contact: Site 0004         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02253992     History of Changes
Other Study ID Numbers: CA186-107
2014-002241-22 ( EudraCT Number )
Study First Received: September 29, 2014
Last Updated: March 3, 2017

Additional relevant MeSH terms:
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
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 28, 2017