Study of the Safety and Tolerability of Urelumab Administered in Combination with Nivolumab Solid Tumors and B-cell Non-Hodgkins Lymphoma

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.

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002241-22-ES

Enrollment

260

Registered

2014-09-22

Start date

2014-12-26

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors Advanced B-cell NHL MedDRA version: 17.1 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 100000004864 MedDRA version: 17.1 Level: LLT Classification code 10025311 Term: Lymphoma (non-Hodgkin's) System Organ Class: 100000004864

Interventions

Product Name: Urelumab Product Code: BMS-663513-01 Pharmaceutical Form: Solution for infusion INN or Proposed INN: urelumab CAS Number:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: For Dose Escalation: Subjects with any previously treated advanced (metastatic or refractory) solid tumor type and B-cell non-Hodgkin lymphoma except subjects who have primary central nervous system tumors or with central nervous system metastases as the only site of active disease ) 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 221 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 39

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of this study is to determine which doses of urelumab and nivolumab are safe and tolerable when they are given together.; Secondary Objective: Best Overall Response (BOR) Objective response rate (ORR), Duration of Response (DOR) Progression-free survival rate (PFSR). Pharmacokinetics: Urelumab maximum concentration Cmax,(µg/mL), time to maximum concentration Tmax (hr), Area under the curve AUCTAU (µg.hr/mL), Area under the curve AUCinf (µg.hr/mL), Clearance (L/day), Volume of distribution (Vss), half life (t1/2), and trough concentration Cmin (µg/mL) will be evaluated using non compartmental analysis in all study subjects. Immunogenicity: Occurrence of specific anti-drug antibodies (ADA) to urelumab and nivolumab, ADA status of the subject ;Primary end point(s): Safety as measured by the rate of adverse events (AEs) and Serious Adverse Events (SAEs), is the primary endpoint of this Phase 1/2 study. All subjects who receive at least one (full or partial) dose of urelumab or nivolumab will be evaluated for safety during treatment and for up to 100 days in follow-up.;Timepoint(s) of evaluation of this end point: During treatment and first 100 days after treatment	—

Measure

Time frame

Main Objective: The purpose of this study is to determine which doses of urelumab and nivolumab are safe and tolerable when they are given together.; Secondary Objective: Best Overall Response (BOR) Objective response rate (ORR), Duration of Response (DOR) Progression-free survival rate (PFSR). Pharmacokinetics: Urelumab maximum concentration Cmax,(µg/mL), time to maximum concentration Tmax (hr), Area under the curve AUCTAU (µg.hr/mL), Area under the curve AUCinf (µg.hr/mL), Clearance (L/day), Volume of distribution (Vss), half life (t1/2), and trough concentration Cmin (µg/mL) will be evaluated using non compartmental analysis in all study subjects. Immunogenicity: Occurrence of specific anti-drug antibodies (ADA) to urelumab and nivolumab, ADA status of the subject ;Primary end point(s): Safety as measured by the rate of adverse events (AEs) and Serious Adverse Events (SAEs), is the primary endpoint of this Phase 1/2 study. All subjects who receive at least one (full or partial) dose of urelumab or nivolumab will be evaluated for safety during treatment and for up to 100 days in follow-up.;Timepoint(s) of evaluation of this end point: During treatment and first 100 days after treatment

—

Secondary

Measure	Time frame
Secondary end point(s): Best Overall Response (BOR) Objective response rate (ORR), Duration of Response (DOR) Progression-free survival rate (PFSR). Pharmacokinetics: Urelumab maximum concentration Cmax,(µg/mL), time to maximum concentration Tmax (hr), Area under the curve AUCTAU (µg.hr/mL), Area under the curve AUCinf (µg.hr/mL), Clearance (L/day), Volume of distribution (Vss), half life (t1/2), and trough concentration Cmin (µg/mL) will be evaluated using non compartmental analysis in all study subjects. Immunogenicity: Occurrence of specific anti-drug antibodies (ADA) to urelumab and nivolumab, ADA status of the subject ; Timepoint(s) of evaluation of this end point: BOR, ORR, DOR, PFS: Every 8 weeks for Cycle 1 through Cycle 12 then every 12 weeks thereafter for approximately 2 years Pharmacokinetics:Time Frame: Cycles 1, 2, 3, 4, 6, 8, 10, 12, and followup Days up to 100 days Immunogenicity: Time Frame: Cycles 1 ,2, 3, 4, 6, 8, 10, 12, and followup Days up to 100 days	—

Measure

Time frame

Secondary end point(s): Best Overall Response (BOR) Objective response rate (ORR), Duration of Response (DOR) Progression-free survival rate (PFSR). Pharmacokinetics: Urelumab maximum concentration Cmax,(µg/mL), time to maximum concentration Tmax (hr), Area under the curve AUCTAU (µg.hr/mL), Area under the curve AUCinf (µg.hr/mL), Clearance (L/day), Volume of distribution (Vss), half life (t1/2), and trough concentration Cmin (µg/mL) will be evaluated using non compartmental analysis in all study subjects. Immunogenicity: Occurrence of specific anti-drug antibodies (ADA) to urelumab and nivolumab, ADA status of the subject ; Timepoint(s) of evaluation of this end point: BOR, ORR, DOR, PFS: Every 8 weeks for Cycle 1 through Cycle 12 then every 12 weeks thereafter for approximately 2 years Pharmacokinetics:Time Frame: Cycles 1, 2, 3, 4, 6, 8, 10, 12, and followup Days up to 100 days Immunogenicity: Time Frame: Cycles 1 ,2, 3, 4, 6, 8, 10, 12, and followup Days up to 100 days

—

Countries

Canada, France, Germany, Netherlands, Spain, United Kingdom, United States

Contacts

Public ContactGCT-SU

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com900 150 160

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026