Study of Nivolumab-Ipilimumab and cfDNA in Lung Cancer

Sponsor
University Health Network, Toronto
Study ID
NCT04966676
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • cfDNA blood test — DIAGNOSTIC_TEST
    Blood sample will be taken for cfDNA testing
  • Nivolumab — DRUG
    Antineoplastic agent
  • Ipilimumab — DRUG
    Antineoplastic agent
  • Platinum-based Chemotherapy — COMBINATION_PRODUCT
    May include carboplatin with gemcitabine, or paclitaxel or pemetrexed

Study Details

The purpose of this research study is to look at how effective two drugs, nivolumab and ipilimumab, are for people with non-small lung cancer that has metastasized (has spread to other parts of the body) and to see what effects these drugs have on these tumors.

Key Dates

Start date
Jan 24, 2022
Status verified
Jan 2026
Primary completion
Feb 19, 2025
Completion
Feb 19, 2025

Study Design

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

Arms

  • Experimental: Non-Small cell Lung Cancer
    Nivolumab, intravenously (given by vein), once every 3 weeks Ipilimumab, intravenously (given by vein), once every 6 weeks Participants will have blood samples taken for cell free deoxyribonucleic acid (cfDNA) testing. If there is an increasing or stable tumor cfDNA, platinum-doublet chemotherapy will be given.

Primary Outcome Measure

Percentage of participants whose disease does not worsen (progression-free survival rate) at 6 months [ Time Frame: 6 months ]

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