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 2TerminatedNCT02253992

Bristol-Myers Squibb232 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

232

Conditions

Advanced Solid Tumors Advanced B-cell NHL

Interventions

UrelumabBIOLOGICAL

NivolumabBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

Stanford University School Of Medicine

Palo Alto, California, United States

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Outcomes

Primary Outcomes

The Incidence of Adverse Events.

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

The Incidence of Seriuos Adverse Events.

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

The Incidence of Death.

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

Secondary Outcomes

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.

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

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.

Time frame: 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

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

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.

Data from ClinicalTrials.gov

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