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

Bristol-Myers Squibb (BMS)

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Advanced Solid Tumors

Advanced B-cell NHL

Treatments

Biological: Nivolumab

Biological: Urelumab

Study type

Interventional

Funder types

Industry

Identifiers

2014-002241-22 (EudraCT Number)

CA186-107

Details and patient eligibility

About

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

Enrollment

232 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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