test

A Multi-arm Phase I Safety Study of Nivolumab in Combination with Gemcitabine/Cisplatin, Pemetrexed/Cisplatin, Carboplatin/Paclitaxel, Bevacizumab Maintenance, Erlotinib, Ipilimumab or as Monotherapy in Subjects with Stage IIIB/IV Non-small Cell Lung Cancer

Conditions

Lung

Trial Phase

Phase I

Trial Purpose and Description

Trial Purpose

The primary objective is safety and tolerability of BMS-936558 in combination with chemotherapy. The primary objective will be measured by: 1) Frequency of adverse events occurring up to 30 days after the last dose of study drug (or longer for drug-related AEs that have not resolved, stabilized, retuned to baseline or been deemed irreversible by 30 days after the last dose) 2) Frequency of serious adverse events occurring up to 90 days after the last dose of study drug (or longer for drug-related SAEs that have notresolved, stabilized, retuned to baseline or been deemed irreversible by 90 days after the last dose) 3) frequency of clinical laboratory test by worst toxicity grade (as assessed at screening, Days 1, 8, and 15 of Cycle 1, Day 1 of Cycle 2+, and end of treatment).


Participation Guidelines

Age:
Gender:

Eligibility Criteria

Inclusion Criteria:

  • Age 18 years of age ECOG performance status of < 1.
  • Measurable disease by CT or MRI per RECIST 1.1 criteria.
  • Subjects must be chemotherapy-naive (except Arm D, K, L, and M). Prior use of EGFR TKI is acceptable.
  • Prior palliative radiotherapy must have been completed at least 2 weeks prior to study entry (Subjects may receive localized palliative radiotherapy while receiving study drug).
  • Subjects must have a baseline O2 saturation by pulse oximetry of >92% at rest.

Exclusion Criteria:

  • Subjects withactive, known or suspected autoimmune disease.
  • Emergent use of systemic corticosteroids for control of CNS/spinal mets
  • Subjects with a history of interstitial pneumonia or lung disease
  • History of Grade 2 neuropathy
  • Subjects with previous malignancies are excluded unless a complete remission was achieved at least 2 years prior to study entry
  • History of transient ischemic accident, Cerebrovascularaccident, thrombotic event approximately within the last 6 months
  • Subjects with previous malignancies are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period
Sponsor:
Bristol-Myers Squibb Company
Dates:
06/12/2012
Last Updated:
Study HIC#:
1110009158