A Safety Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Non-small Cell Lung Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03048136
Phase
PHASE3
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Specified dose on specified days
  • Ipilimumab — DRUG
    Specified dose on specified days

Study Details

A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab

Key Dates

Start date
Mar 9, 2018
Status verified
Apr 2018
Primary completion
Sep 29, 2019
Completion
Sep 29, 2019

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Flat-Dose
    Nivolumab flat dose + Ipilimumab
  • Experimental: Weight-Based Dose
    Nivolumab weight-based dose + Ipilimumab

Primary Outcome Measure

Incidence of high grade (Grade 3-4 and Grade 5) treatment-related select adverse events [ Time Frame: Approximately 3 months ]

Locations (9)

FacilityCityStateZIPSite coordinators
Local InstitutionSan FranciscoCalifornia94115-
Local InstitutionLincolnNebraska68506-
Local InstitutionHackensackNew Jersey07601-
Local InstitutionColumbusOhio43210-
Local InstitutionLancasterPennsylvania17604-
Local InstitutionLanghornePennsylvania19047-
Local InstitutionSayrePennsylvania18840-
Local InstitutionCharlestonSouth Carolina29414-
Local InstitutionSt. GeorgeUtah84770-

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