Study of Urelumab in Subjects With Advanced and/or Metastatic Malignant Tumors

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Malignant Tumors

Treatments: Drug: Urelumab; Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02534506

CA186-110

Details and patient eligibility

About

The purpose of this study is to assess the safety and tolerability of BMS-663513 in subjects with advanced and/or metastatic malignant tumors.

Enrollment: 18 estimated patients

Sex: All

Ages: 20+ 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:

• Subjects with previously treated advanced malignant solid tumor
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
• For certain subjects, willing and able to provide pre-treatment tumor sample

Exclusion Criteria:

• Known or suspected 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Urelumab (+ Nivolumab) intravenous (IV) infusion

Experimental group

Treatment:

Drug: Nivolumab

Drug: Urelumab