Safety and Efficacy Study of Ulocuplumab and Nivolumab in Subjects With Solid Tumors (CXCessoR4)

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Solid Tumor

Treatments: Drug: Ulocuplumab; Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02472977

2015-000136-15 (EudraCT Number)

CA212-115

Details and patient eligibility

About

The purpose of this study is to determine whether the combination of Ulocuplumab and Nivolumab is safe and effective in the treatment of pancreatic cancer and small cell lung cancer.

Full description

• Intervention model: Single group for Stage 1 DLT, then Parallel
• Data Monitoring Committee: No (Stage 1) Yes (Stage 2 Randomized Ph2)

Enrollment: 61 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:

• SCLC or PAC that is advanced or has spread to other parts of the body
• Treated with at least one other chemotherapy that did not work or where cancer relapsed
• Minimal limitations on activities of daily living as measured by Eastern Cooperative Oncology Group (ECOG) score of 0-1

Exclusion Criteria:

• Patients with cancer that spread to the brain
• Active, known or suspected autoimmune disease
• Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (SCLC)

Active Comparator group

Description:

Small cell lung cancer (SCLC)

Treatment:

Drug: Ulocuplumab

Drug: Nivolumab

BMS-936564 (Ulocuplumab) + Nivolumab, Tumor type arm (PAC)

Active Comparator group

Description:

Pancreatic cancer (PAC)

Treatment:

Drug: Ulocuplumab

Drug: Nivolumab