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

Phase 1

Terminated

• Conditions: Advanced B-cell NHL; Advanced Solid Tumors
• Interventions: Biological: Urelumab; Biological: Nivolumab

• Registration Number: NCT02253992
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-29
• Study First Submitted: 2014-09-29
• Study First Submitted QC: 2014-09-29
• Study First Posted: 2014-10-01
• Primary Completion: 2019-05-24
• Study Completion: 2019-05-24
• Results First Submitted: 2020-05-19
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-10
• Last Update Submitted: 2020-09-10
• Results First Posted: 2020-10-05
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 232

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose Escalation and Cohort expansion: Urelumab + Nivolumab	Urelumab	Nivolumab followed by Urelumab Nivolumab every 2 weeks up to 12 cycles and Urelumab every 4 weeks up to 6 cycles
Dose Escalation and Cohort expansion: Urelumab + Nivolumab	Nivolumab	Nivolumab followed by Urelumab Nivolumab every 2 weeks up to 12 cycles and Urelumab every 4 weeks up to 6 cycles

Primary Outcome Measures

Name	Time	Method
The Incidence of Adverse Events.	From day 1 until 100 days after participant last dose of study drug.
The Incidence of Death.	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.

Secondary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve in One Dosing Interval (AUCTAU)	Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days	Data was not collected due to discontinuation of the study/Due to study termination.
Objective Response Rate (ORR)	Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.	Objective response rate (ORR) is defined as the total number of subjects whose BOR is either CR or PR divided by the total number of subjects in the population of interest.
Area Under the Plasma Concentration-time Curve, 0 to Time of Last Quantifiable Concentration (AUC(0-T)	Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.	Data was not collected due to discontinuation of the study/Due to study termination.
Best Overall Response (BOR)	Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.	The total number of subjects whose best overall response (BOR) is either a complete response or partial response for solid tumors and complete remission or partial remission for B-cell NHL, divided by the total number of subjects in the population of interest.
Progression-free Survival Rate (PFSR)	Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.	PFSR is defined as the probability of a subject remaining progression-free and surviving a specific length of time.; Data was not collected due to discontinuation of the study/Due to study termination.
Trough Observed Plasma Concentration(Ctrough)	Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.	Data was not collected due to discontinuation of the study/Due to study termination.
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	DOR is defined as the number of days between the date of first response and the subsequent date of objectively documented disease progression based on the criteria (RECIST v1.1) or relapse based on IWG, or death due to any cause, if death occurred within 100 days after last dose, whichever occurs first.; Data was not collected due to discontinuation of the study/Due to study termination.
Maximum Observed Serum Concentration (Cmax)	Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.	Data was not collected due to discontinuation of the study/Due to study termination.
Time of Maximum Observed Serum Concentration (Tmax)	Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.	Data was not collected due to discontinuation of the study/Due to study termination.
End of Infusion Concentration (Ceoinf)	Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.	Data was not collected due to discontinuation of the study/Due to study termination.

Trial Locations

Locations (14)

Stanford University School Of Medicine; 🇺🇸 Palo Alto, California, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

UPMC Cancer Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

NYU Langone Medical Center; 🇺🇸 New York, New York, United States

University Of Chicago; 🇺🇸 Chicago, Illinois, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center; 🇺🇸 Lutherville, Maryland, United States

Memorial Sloan Kettering Nassau; 🇺🇸 New York, New York, United States

Providence Portland Medical Center; 🇺🇸 Portland, Oregon, United States

Clinica Universidad de Navarra; 🇪🇸 Pamplona, Spain

Local Institution; 🇫🇷 Villejuif, France

Universitaetsklinikum Essen; 🇩🇪 Essen, Germany

Md Anderson; 🇺🇸 Houston, Texas, United States

H. Lee Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States