An Open Label Investigational Immuno-therapy Trial of Nivolumab in Cancers That Are Advanced or Have Spread (CheckMate 627)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Cancer

Treatments: Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02832167

2016-000461-23 (EudraCT Number)

CA209-627

Details and patient eligibility

About

The purpose of this study is to determine whether nivolumab is an effective treatment for cancer that has advanced or has spread. Various tumor types may be eligible for enrollment.

Enrollment: 239 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with advanced or metastatic malignancy
• Received standard of care treatment for primary malignancy and standard of care treatment for relapsed cancer
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion criteria

• Prior treatment with an antiPD1, antiPDL1, antiPDL2, antiCD137, or antiCTLA4 antibody, or any other antibody or drug specifically targeting Tcell co-stimulation or checkpoint pathways.
• Subjects previously treated with investigational anticancer therapies less than 6 weeks prior to the first dose of Nivolumab
• Subjects with an active, known, or suspected autoimmune disease

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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239 participants in 1 patient group

Nivolumab

Experimental group

Treatment:

Biological: Nivolumab