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

NCT02253992 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: CA186-1072014-002241-22
• Study Type: interventional
• Target: 232
• Locations: 4 countries
• Sites: 17

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.

Conditions

Advanced Solid Tumors; Advanced B-cell NHL

Outcome Measures

Primary Outcomes (3)

• The Incidence of Adverse Events.

  From day 1 until 100 days after participant last dose of study drug.

• The Incidence of Seriuos Adverse Events.

  From day 1 until 100 days after participant last dose of the study drug.

• The Incidence of Death.

  From day 1 until 100 days after participant last dose of study drug.

Secondary Outcomes (11)

• Best Overall Response (BOR)

  Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.

• Objective Response Rate (ORR)

  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

  Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.

• Duration of Response (DOR)

  Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years

• Progression-free Survival Rate (PFSR)

  Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.

Study Arms (1)

Dose Escalation and Cohort expansion: Urelumab + Nivolumab

EXPERIMENTAL

Nivolumab followed by Urelumab Nivolumab every 2 weeks up to 12 cycles and Urelumab every 4 weeks up to 6 cycles

Biological: Urelumab; Biological: Nivolumab

Interventions

Urelumab BIOLOGICAL

Also known as: BMS-663513

Dose Escalation and Cohort expansion: Urelumab + Nivolumab

Nivolumab BIOLOGICAL

Also known as: BMS-936558

Dose Escalation and Cohort expansion: Urelumab + Nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (17)

Stanford University School Of Medicine

Palo Alto, California, 94304, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

University Of Chicago

Chicago, Illinois, 60637, United States

Location

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Lutherville, Maryland, 21093, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Memorial Sloan Kettering Nassau

New York, New York, 10065, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

UPMC Cancer Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Md Anderson

Houston, Texas, 77030, United States

Location

Local Institution

Besançon, 25000, France

Location

Local Institution

Marseille, 13005, France

Location

Local Institution

Rennes, 35033, France

Location

Local Institution

Villejuif, 94805, France

Location

Universitaetsklinikum Essen

Essen, 45147, Germany

Location

Clinica Universidad de Navarra

Pamplona, 31008, Spain

Location

Related Publications (1)

• Khushalani NI, Ott PA, Ferris RL, Cascone T, Schadendorf D, Le DT, Sharma MR, Barlesi F, Sharfman W, Luke JJ, Melero I, Lathers D, Neely J, Suryawanshi S, Sanyal A, Holloway JL, Suryawanshi R, Ely S, Segal NH. Final results of urelumab, an anti-CD137 agonist monoclonal antibody, in combination with cetuximab or nivolumab in patients with advanced solid tumors. J Immunother Cancer. 2024 Mar 7;12(3):e007364. doi: 10.1136/jitc-2023-007364.

  PMID: 38458639 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Interventions

urelumab; Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 1, 2014
• Study Start: September 29, 2014
• Primary Completion: May 24, 2019
• Study Completion: May 24, 2019
• Last Updated: October 5, 2020
• Results First Posted: October 5, 2020

Record last verified: 2020-09

Locations

US (11); DE (1); ES (1); FR (4)