Clinical trial NCT02253992: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
Advanced B-cell NHL
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-10-01
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: The Incidence of Adverse Events.
timeFrame: From day 1 until 100 days after participant last dose of study drug.
measure: The Incidence of Seriuos Adverse Events.
timeFrame: From day 1 until 100 days after participant last dose of the study drug.
measure: The Incidence of Death.
timeFrame: From day 1 until 100 days after participant last dose of study drug.
Secondary outcomes:
measure: Best Overall Response (BOR)
timeFrame: Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.
measure: Objective Response Rate (ORR)
timeFrame: Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.
measure: Occurrence of Specific Anti-drug Antibodies (ADA) to Urelumab and Nivolumab
timeFrame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
measure: Duration of Response (DOR)
timeFrame: Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years
measure: Progression-free Survival Rate (PFSR)
timeFrame: Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.
measure: Maximum Observed Serum Concentration (Cmax)
timeFrame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
measure: Time of Maximum Observed Serum Concentration (Tmax)
timeFrame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
measure: Area Under the Concentration-time Curve in One Dosing Interval (AUCTAU)
timeFrame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days
measure: Trough Observed Plasma Concentration(Ctrough)
timeFrame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
measure: End of Infusion Concentration (Ceoinf)
timeFrame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
measure: Area Under the Plasma Concentration-time Curve, 0 to Time of Last Quantifiable Concentration (AUC(0-T)
timeFrame: Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University School Of Medicine
state: California
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: University Of Chicago
state: Illinois
city: Lutherville
country: United States
facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: Md Anderson
state: Texas
city: Besancon
country: France
facility: Local Institution
city: Marseille
country: France
facility: Local Institution
city: Rennes Cedex 9
country: France
facility: Local Institution
city: Villejuif
country: France
facility: Local Institution
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: