Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients

Part of paid clinical trials in San Francisco, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02899299
Phase
PHASE3
Status
Completed

Conditions

  • Mesothelioma

Eligibility Criteria

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

Interventions

  • Nivolumab — BIOLOGICAL
  • Ipilimumab — BIOLOGICAL
  • Pemetrexed — DRUG
  • Cisplatin — DRUG
  • Carboplatin — DRUG

Study Details

The purpose of this study is to test the effectiveness and tolerability of the combination of Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients with unresectable pleural mesothelioma.

Key Dates

Start date
Nov 29, 2016
Status verified
Apr 2024
Primary completion
Mar 25, 2020
Completion
Apr 28, 2023

Study Design

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

Arms

  • Experimental: Nivolumab and Ipilimumab
    Specified dose on specified days
  • Active Comparator: Pemetrexed and Cisplatin (or Carboplatin)
    Specified dose on specified days

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From randomization to the date of death (Up to 40 Months) ]

Locations (14)

FacilityCityStateZIPSite coordinators
UcsfSan FranciscoCalifornia94143-
Local Institution - 0014New HavenConnecticut06520-
H. Lee Moffitt Cancer Center & Research Inst, IncTampaFlorida33612-
Local Institution - 0002ChicagoIllinois60637-
Univ Of Maryland Greenbaum Cancer CenterBaltimoreMaryland21201-
Local Institution - 0013DetroitMichigan48201-
Cancer & Hematology Centers Of Western MichiganGrand RapidsMichigan49503-
Local Institution - 0004RochesterMinnesota55905-
Memorial Sloan Kettering NassauNew YorkNew York10065-
Local Institution - 0007ClevelandOhio44195-
University Of PennsylvaniaPhiladelphiaPennsylvania19104-
Allegheny Cancer CenterPittsburghPennsylvania15212-
Local Institution - 0005HoustonTexas77030-
West Virginia UniversityMorgantownWest Virginia26506-

Find similar trials in San Francisco, CA

By research site
Ucsf· San Francisco, CALocal Institution - 0014· New Haven, CTH. Lee Moffitt Cancer Center & Research Inst, Inc· Tampa, FLLocal Institution - 0002· Chicago, ILUniv Of Maryland Greenbaum Cancer Center· Baltimore, MDLocal Institution - 0013· Detroit, MI

Related Studies