PhII Trial Panitumumab, Nivolumab, Ipilimumab in Kras/Nras/BRAF Wild-type MSS Refractory mCRC

Part of paid clinical trials in Tampa, Florida.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT03442569
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Panitumumab — DRUG
    6 mg/kg via IV every 2 weeks in combination with nivolumab and ipilimumab
  • Nivolumab — DRUG
    240 mg via IV every 2 weeks in combination with panitumumab and ipilimumab
  • Ipilimumab — DRUG
    1 mg/kg via IV every 6 weeks in combination with nivolumab and panitumumab

Study Details

To investigate the combination of nivolumab and ipilimumab with panitumumab in subjects with unresectable, refractory, KRAS/NRAS/BRAF wild-type, microsatellite stable (MSS) metastatic colorectal cancer.

Key Dates

Start date
Mar 9, 2018
Status verified
Jun 2025
Primary completion
Sep 21, 2020
Completion
Dec 2, 2024

Study Design

Enrollment
56 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Open-label, single arm, Phase II
    Nivolumab and ipilimumab with panitumumab

Primary Outcome Measure

Overall Response Rate [ Time Frame: 12 weeks ]

Locations (5)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-
Indiana University Health Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-
University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27509-
Vanderbilt University Medical CenterNashvilleTennessee37232-
University of Washington - Seattle Cancer Care AllianceSeattleWashington98109-

Find similar trials in Tampa, FL

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Moffitt Cancer Center· Tampa, FLIndiana University Health Melvin and Bren Simon Cancer Center· Indianapolis, INUniversity of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center· Chapel Hill, NCVanderbilt University Medical Center· Nashville, TNUniversity of Washington - Seattle Cancer Care Alliance· Seattle, WA

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