Nivolumab in Combination With Ipilimumab (Part 1); Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer

Part of paid clinical trials in San Diego, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02659059
Phase
PHASE2
Status
Completed

Conditions

  • Non-Small-Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
    Specified Dose on Specified Days
  • Ipilimumab — BIOLOGICAL
    Specified Dose on Specified Days
  • Platinum Doublet Chemotherapy — DRUG

Study Details

The purpose of part 1 of this study is to determine the objective response rate (ORR) in stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line therapy. The purpose of part 2 of this study is to determine the safety and tolerability of nivolumab and ipilimumab combined with a short course of chemotherapy in first line stage IV NSCLC.

Key Dates

Start date
Feb 15, 2016
Status verified
Mar 2023
Primary completion
Jun 22, 2018
Completion
Mar 7, 2022

Study Design

Enrollment
324 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab+Ipilimumab
    Part 1 Specified Dose on Specified Days
  • Experimental: Nivolumab+Ipilimumab + 2 cycles Platinum Doublet Chemotherapy
    Part 2 Specified Dose on Specified Days

Primary Outcome Measure

Objective Response Rate (ORR) by PD-L1 Positive and Negative Levels - Part 1 [ Time Frame: From first dose to database lock (Up to 18 months) ]

Locations (29)

FacilityCityStateZIPSite coordinators
Sharp Memorial HospitalSan DiegoCalifornia92123-
Cancer Center Of Central ConnecticutPlainvilleConnecticut06062-
Cleveland Clinic FloridaWestonFlorida33331-
Winship Cancer Institute.AtlantaGeorgia30322-
Summit Cancer CareSavannahGeorgia31405-
Cancer Center Of KansasWichitaKansas67214-
University Of Louisville Medical Center, Inc., DbaLouisvilleKentucky40202-
Johns Hopkins Cancer CenterBaltimoreMaryland21287-
Local Institution - 0029BostonMassachusetts02114-2621-
Local Institution - 0030BostonMassachusetts02114-2621-
Massachusetts General HospitalBostonMassachusetts02114-
Henry Ford Health SystemDetroitMichigan48202-
Local Institution - 0015LincolnNebraska68506-
Hackensack University Medical CenterHackensackNew Jersey07601-
Local Institution - 0036AlbuquerqueNew Mexico87106-
Lovelace Cancer CareAlbuquerqueNew Mexico87131-
New Mexico Cancer Care AllianceAlbuquerqueNew Mexico87131-
New Mexico Cancer Care CenterAlbuquerqueNew Mexico87131-
The Cancer Center at PresbyterianAlbuquerqueNew Mexico87131-
Local Institution - 0010MineolaNew York11501-
Memorial Sloan Kettering NassauNew YorkNew York10065-
Duke UniversityDurhamNorth Carolina27710-
Novant Health Oncology SpecialistsWinston-SalemNorth Carolina27103-
The Ohio State UniversityColumbusOhio43210-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-2412-
Local Institution - 0006PittsburghPennsylvania15212-
Charleston Hematology Oncology Associates, PaCharlestonSouth Carolina29414-
Tennessee Oncology, PLLC - SCRI - PPDSNashvilleTennessee37203-
Vanderbilt University Medical CenterNashvilleTennessee37232-6307-

Find similar trials in San Diego, CA

By research site
Sharp Memorial Hospital· San Diego, CACancer Center Of Central Connecticut· Plainville, CTCleveland Clinic Florida· Weston, FLWinship Cancer Institute.· Atlanta, GASummit Cancer Care· Savannah, GACancer Center Of Kansas· Wichita, KS

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