Phase II Clinical Trial of NIVO-IPI-TAXANE in Untreated Metastatic NSCLC

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Jeffrey Clarke
Study ID
NCT03573947
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    360 mg intravenously every 3 weeks
  • Ipilimumab — DRUG
    1 mg/kg intravenously over 30 minutes
  • Paclitaxel — DRUG
    80 mg/m2 on days 1 and 8 of every 21-day treatment cycle

Study Details

This is an open-label, non-randomized, phase II clinical research study designed to assess the safety and efficacy of nivolumab and ipilimumab in combination with paclitaxel in patients with treatment naïve NSCLC.

Key Dates

Start date
Oct 2, 2018
Status verified
Sep 2025
Primary completion
Mar 12, 2023
Completion
Jun 15, 2023

Study Design

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

Arms

  • Experimental: nivolumab, ipilimumab and paclitaxel
    patients will be treated with nivolumab and ipilimumab in combination with weekly paclitaxel days 1 and 8 every 21 days until they experience unacceptable drug-related toxicity, disease progression or 24 months. The dosing regimen will be: nivolumab 360 mg every 3 weeks, ipilimumab 1 mg/kg every 6 weeks, and paclitaxel 80 mg/m2 on days 1 and 8 of 1 21 day treatment cycle. Paclitaxel would be stopped after a total of 4-6 cycles of treatment.

Primary Outcome Measure

Progression-free Survival (PFS) as Determined by the Investigator Using Response Evaluation Criteria In Solid Tumors RECIST 1.1 (Brand Name) or Death, Whichever Occurs First [ Time Frame: up to 4 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710-

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Duke University Medical Center· Durham, NC

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