A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors

Part of paid clinical trials in Muscle Shoals, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT01928394
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Advanced or Metastatic Solid Tumors

Eligibility Criteria

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

Interventions

Study Details

To investigate the safety and efficacy of nivolumab as a single agent or in combination with ipilimumab in 6 tumor types - triple-negative breast cancer (TNBC), gastric cancer (GC), pancreatic adenocarcinoma (PC), small cell lung cancer (SCLC), bladder cancer (BC), and ovarian cancer (OC). A combination of nivolumab with ipilimumab and cobimetinib is also investigated in PC.

Key Dates

Start date
Oct 24, 2013
Status verified
Dec 2024
Primary completion
Feb 5, 2019
Completion
Nov 18, 2024

Study Design

Enrollment
1,163 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm N - Nivolumab
    Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
  • Experimental: Arm N-I, Level 1: Nivolumab+Ipilimumab
    Nivolumab 1 mg/kg solution intravenously plus Ipilimumab 1 mg/kg solution every 3 weeks for 4 doses followed by Nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
  • Experimental: Arm N-I, Level 2: Nivolumab+Ipilimumab
    Nivolumab 1 mg/kg solution intravenously plus Ipilimumab 3 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
  • Experimental: Arm N-I, Level 2b: Nivolumab+Ipilimumab
    Nivolumab 3 mg/kg solution intravenously plus Ipilimumab 1 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
  • Experimental: Arm N-I, Level 2c: Nivolumab+Ipilimumab
    Nivolumab 3 mg/kg solution intravenously every 3 weeks combined with ipilimumab 1 mg/kg every 6 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
  • Experimental: Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib
    Nivolumab 3 mg/kg solution intravenously every 3 weeks combined with ipilimumab 1 mg/kg every 6 weeks and cobimetinib 60mg once daily 21days on/7 days off until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

Primary Outcome Measure

Objective Response Rate ( ORR ) [ Time Frame: 60 months ]

Locations (19)

FacilityCityStateZIPSite coordinators
Local Institution - 0047Muscle ShoalsAlabama35661-
Local Institution - 0044AuroraColorado80045-
Local Institution - 0015New HavenConnecticut06520-
Local Institution - 0046GainesvilleFlorida32610-
Local Institution - 0021TampaFlorida33612-
Local Institution - 0001AtlantaGeorgia30322-
Local Institution - 0004BaltimoreMaryland21287-
Local Institution - 0005BostonMassachusetts02215-
Local Institution - 0043BostonMassachusetts02215-
Local Institution - 0049OmahaNebraska68130-
Local Institution - 0045MineolaNew York11501-
Local Institution - 0006New YorkNew York10065-
Local Institution - 0003CharlotteNorth Carolina28204-
Local Institution - 0008DurhamNorth Carolina27710-
Local Institution - 0007PortlandOregon97239-
Local Institution - 0011FranklinTennessee37067-
Local Institution - 0002NashvilleTennessee37232-
Local Institution - 0009HoustonTexas77030-
Local Institution - 0042SeattleWashington98104-

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By research site
Local Institution - 0047· Muscle Shoals, ALLocal Institution - 0044· Aurora, COLocal Institution - 0015· New Haven, CTLocal Institution - 0046· Gainesville, FLLocal Institution - 0021· Tampa, FLLocal Institution - 0001· Atlanta, GA

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