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

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02253992
• Other study ID #: CA186-107
• Secondary ID: 2014-002241-22
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: September 29, 2014
• Est. completion date: May 24, 2019

Study information

• Verified date: September 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine which doses of Urelumab and Nivolumab are safe and tolerable when they are given together.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 232
• Est. completion date: May 24, 2019
• Est. primary completion date: May 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced B-cell NHL
• Advanced Solid Tumors
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin

Intervention

Biological:
• Urelumab

• Nivolumab

Locations

Country	Name	City	State
France	Local Institution	Besancon
France	Local Institution	Marseille
France	Local Institution	Rennes Cedex 9
France	Local Institution	Villejuif
Germany	Universitaetsklinikum Essen	Essen
Spain	Clinica Universidad de Navarra	Pamplona
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	University Of Chicago	Chicago	Illinois
United States	Md Anderson	Houston	Texas
United States	Johns Hopkins Sidney Kimmel Comprehensive Cancer Center	Lutherville	Maryland
United States	Memorial Sloan Kettering Nassau	New York	New York
United States	NYU Langone Medical Center	New York	New York
United States	Stanford University School Of Medicine	Palo Alto	California
United States	UPMC Cancer Center	Pittsburgh	Pennsylvania
United States	Providence Portland Medical Center	Portland	Oregon
United States	H. Lee Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  France,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Incidence of Adverse Events.		From day 1 until 100 days after participant last dose of study drug.
Primary	The Incidence of Seriuos Adverse Events.		From day 1 until 100 days after participant last dose of the study drug.
Primary	The Incidence of Death.		From day 1 until 100 days after participant last dose of study drug.
Secondary	Best Overall Response (BOR)	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.	Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.
Secondary	Objective Response Rate (ORR)	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.	Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.
Secondary	Occurrence of Specific Anti-drug Antibodies (ADA) to Urelumab and Nivolumab		Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Secondary	Duration of Response (DOR)	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.	Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years
Secondary	Progression-free Survival Rate (PFSR)	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.	Every 8 weeks for Cycle 1 through Cycle 6 then every 12 weeks thereafter for approximately 2 years.
Secondary	Maximum Observed Serum Concentration (Cmax)	Data was not collected due to discontinuation of the study/Due to study termination.	Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Secondary	Time of Maximum Observed Serum Concentration (Tmax)	Data was not collected due to discontinuation of the study/Due to study termination.	Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Secondary	Area Under the Concentration-time Curve in One Dosing Interval (AUCTAU)	Data was not collected due to discontinuation of the study/Due to study termination.	Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days
Secondary	Trough Observed Plasma Concentration(Ctrough)	Data was not collected due to discontinuation of the study/Due to study termination.	Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Secondary	End of Infusion Concentration (Ceoinf)	Data was not collected due to discontinuation of the study/Due to study termination.	Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.
Secondary	Area Under the Plasma Concentration-time Curve, 0 to Time of Last Quantifiable Concentration (AUC(0-T)	Data was not collected due to discontinuation of the study/Due to study termination.	Cycles 1, 2, 3, 4, 6, and followup Days up to 100 days.

External Links

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