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

Completed · Phase 4

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT02869789

Run by

Bristol-Myers Squibb

People needed

1041

Starts

2016-10-05

Expected to finish

2022-05-13

Last updated by the study team

2023-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution - 0148 — Phoenix, Arizona, United States
• Local Institution - 0085 — Tucson, Arizona, United States
• Local Institution - 0164 — Little Rock, Arkansas, United States
• Local Institution - 0146 — Bakersfield, California, United States
• Marin Cancer Care, Inc — Greenbrae, California, United States
• Los Angeles Hematology/Oncology Medical Group — Los Angeles, California, United States
• Local Institution - 0115 — Los Angeles, California, United States
• Torrance Health Association — Redondo Beach, California, United States
• Va San Diego Healthcare System — San Diego, California, United States
• Local Institution - 0143 — San Luis Obispo, California, United States
• Local Institution - 0144 — Santa Maria, California, United States
• Gene Upshaw Memorial Tahoe Forest Cancer Center — Truckee, California, United States
• Local Institution - 0161 — Whittier, California, United States
• Local Institution - 0083 — Denver, Colorado, United States
• Local Institution - 0141 — Grand Junction, Colorado, United States
• Cancer Specialists of North FL — Jacksonville, Florida, United States
• Local Institution - 0082 — Ocala, Florida, United States
• Local Institution - 0147 — Pembroke Pines, Florida, United States
• Local Institution - 0163 — Athens, Georgia, United States
• Local Institution - 0002 — Atlanta, Georgia, United States
• Local Institution - 0166 — Atlanta, Georgia, United States
• Local Institution - 0088 — Niles, Illinois, United States
• Local Institution - 0108 — Wichita, Kansas, United States
• Kentucky One Health St. Joseph East Cancer Center — Lexington, Kentucky, United States
• Local Institution - 0121 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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