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

Phase 1

• Conditions: Advanced Solid Tumors Advanced B-cell NHL; MedDRA version: 20.0 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 100000004864; MedDRA version: 20.0 Level: LLT Classification code 10025311 Term: Lymphoma (non-Hodgkin's) System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-002241-22-DE
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-21
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 260

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 220
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified