An Investigational Immuno-therapy Safety Trial of Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma (CheckMate 374)

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 4

Conditions

Renal Cell Carcinoma

Treatments

Drug: Nivolumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02596035

CA209-374

2015-003286-28 (EudraCT Number)

Details and patient eligibility

About

This study will generate safety data on Nivolumab given by itself in treatment of advanced Renal Cell Carcinoma (RCC). The primary objective of this study is to assess immune related side effects, also known as immune-mediated adverse events (IMAEs), in patients treated with Nivolumab.

Enrollment

197 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Advanced or Metastatic renal cell carcinoma (RCC)
Predominant clear cell histology:
1. At least 1 but no more than 2 prior systemic anti vascular endothelial growth factor (anti-VEGF) treatments
2. No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting
3. Subjects with prior treatment with a mechanistic target of rapamycin (mTOR) are eligible
Non-clear cell histology: 0-3 prior systemic therapies and may include mTOR inhibitor
Brain metastases allowed if asymptomatic, without edema, and not receiving corticosteroids or radiation
Performance Status (PS): ≥ 70% Karnofsky Performance Scale (KPS)
All Memorial Sloan-Kettering Cancer Center (MSKCC) prognostic scores allowed

Exclusion criteria

Subjects with any active autoimmune disease or a history of known autoimmune disease
History of severe hypersensitivity reaction to other monoclonal antibodies
Prior malignancy, active within the last 3 years, except for locally curable cancers which have been apparently cured
Known HIV or AIDS-related illness
Any positive tests for Hepatitis B or Hepatitis C virus indicating acute or chronic infection

Other protocol-defined inclusion/exclusion criteria apply