Feasibility and Safety Study of Nivolumab With Irinotecan for Small Cell Lung Cancer
NCT ID: NCT04173325
Last Updated: 2022-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
10 participants
INTERVENTIONAL
2020-01-06
2022-05-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nivolumab and Irinotecan
Drug: Nivolumab 360mg IV Day 1 of each 21 day cycle until disease progression or unacceptable toxicity + Drug: Irinotecan 500mg IV Day of each 21 day cycle for 2 cycles Followed by maintenance nivolumab (without irinotecan)
Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]
PD-1 inhibitor approved by the US FDA for treatment of patients with lung cancer.
Irinotecan Injection [Camptosar]
Chemotherapy drug currently FDA approved for treatment of multiple tumors, including small cell lung cancer.
Interventions
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Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]
PD-1 inhibitor approved by the US FDA for treatment of patients with lung cancer.
Irinotecan Injection [Camptosar]
Chemotherapy drug currently FDA approved for treatment of multiple tumors, including small cell lung cancer.
Eligibility Criteria
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Inclusion Criteria
* Patients who have received at least 1 prior platinum-based chemotherapy.
* Life expectancy of 3 months or more.
* Measurable disease.
Exclusion Criteria
* Currently receiving chemotherapy.
* Pregnant and nursing women.
18 Years
ALL
No
Sponsors
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Augusta University
OTHER
Responsible Party
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Nagla Abdel Karim
Professor, Hematology/Oncology, Director of Thoracic Oncology and Phase I Program
Principal Investigators
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Nagla A Karim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Augusta University Georgia Cancer Center
Locations
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Georgia Cancer Center at AU Medical Center
Augusta, Georgia, United States
Countries
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Other Identifiers
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GCC-20-009
Identifier Type: -
Identifier Source: org_study_id
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