Evaluate the Mediators of Sensitivity and Resistance to Nivolumab Plus Ipilimumab in Patients With Advanced NSCLCs

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT02350764
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Stage Non-small Cell Lung Cancer

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to closely examine tumor and blood samples from patients treated with nivolumab and ipilimumab in order to try to identify why some patients with lung cancers respond and why some patients do not.

Key Dates

Start date
Jan 20, 2015
Status verified
Sep 2023
Primary completion
Sep 25, 2023
Completion
Sep 25, 2023

Study Design

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

Arms

  • Experimental: Nivolumab
    Patients will begin treatment with nivolumab IV 3mg/kg and ipilimumab 1mg/kg. Treatment with nivolumab will continue every 2 weeks (+/- 3 days) thereafter and treatment with ipilimumab will continue every 6 weeks (+/- 3 days) thereafter. Treatment will continue until protocol-defined toxicity, confirmed progression of disease\*, withdrawal of consent, or death.

Primary Outcome Measure

Best Overall Response Rate (Confirmed Partial + Complete Response) Will be Assessed as Part of This Study. Tumor Response Will be Assessed Using RECIST 1.1) [ Time Frame: every 6 weeks (+/- 1 week) until week 48 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

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