This study is in progress, not accepting new patients

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

a study on Lung Cancer Non-Small Cell Lung Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

Summary

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.

Official Title

A Phase 3b/4 Safety Trial of Flat Dose Nivolumab In Combination With Ipilimumab in Participants With Non-Small Cell Lung Cancer

Keywords

Lung Cancer Lung Neoplasms Nivolumab Ipilimumab Nivolumab in combination with Ipilimumab

Eligibility

For people ages 18 years and up

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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 could apply

Locations

  • Va San Diego Healthcare System
    San Diego California 92161 United States
  • Innovative Clinical Research Institute
    Whittier California 90603 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting FDA Safety Alerts and Recalls
ID
NCT02869789
Phase
Phase 4 Research Study
Study Type
Interventional
Participants
At least 1036 people participating
Last Updated