An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 4

Conditions

Lung Cancer

Treatments

Drug: Nivolumab in combination with Ipilimumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02869789

2016-002621-10 (EudraCT Number)

CA209-817

Details and patient eligibility

About

A study to evaluate the safety of Nivolumab given in combination with Ipilimumab in patients with advanced cancers. The initial group will enroll patients with newly diagnosed Stage 4 or non-small cell lung cancer that has come back.

Enrollment

1,041 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically confirmed Stage 4 or recurrent non-small cell lung cancer
Eastern Cooperative Oncology Group (ECOG) score 0-1 (Physically able to carry out light housework or office work through to being fully active as you were before cancer)
No prior systemic anticancer therapy (including EGFR and ALK inhibitors)
Tissue or Programmed death-ligand 1 (PD-L1) results available

Cohort 1A Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) score 2 or
Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria as listed in the protocol

Cohort C Inclusion Criteria:

High Tumor Mutation Burden

Exclusion criteria

Untreated brain metastases
An active malignancy that requires concurrent intervention
Active, known or suspected autoimmune disease
Carcinomatous meningitis, which means there is inflammation of the covering of the brain, caused by cancer

Other protocol-defined inclusion/exclusion criteria apply