Feasibility and Safety Study of Nivolumab With Irinotecan for Small Cell Lung Cancer
Phase 1
Terminated
- Conditions
- Small Cell Lung CarcinomaSmall-cell Lung Cancer
- Interventions
- Registration Number
- NCT04173325
- Lead Sponsor
- Augusta University
- Brief Summary
This study will determine the frequency of adverse events (side effects) in patients with relapsed or refractory small cell lung cancer (SCLC) when given nivolumab and irinotecan together followed by nivolumab maintenance. This study will test the safety of the study treatments when given together and see what effect (good or bad) it has on participants and their cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- Confirmed SCLC with known UGT1A genotype.
- Patients who have received at least 1 prior platinum-based chemotherapy.
- Life expectancy of 3 months or more.
- Measurable disease.
Exclusion Criteria
- Patients with UGT1A polymorphism.
- Currently receiving chemotherapy.
- Pregnant and nursing women.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nivolumab and Irinotecan Irinotecan Injection [Camptosar] 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 and Irinotecan Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] 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)
- Primary Outcome Measures
Name Time Method Evaluate the frequency and severity of adverse events in patients with small cell lung cancer after receiving nivolumab plus irinotecan followed by nivolumab maintenance. through study completion, an average of 1 year CTCAE v.4.0. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) through study completion, an average of 1 year PFS as measured from start of therapy till disease progression.
Overall response rate through study completion, an average of 1 year Tumor response evaluation with RECIST
Overall survival (OS) through study completion, an average of 1 year. OS as measured from start of therapy till date of death or last follow up assessment.
Trial Locations
- Locations (1)
Georgia Cancer Center at AU Medical Center
🇺🇸Augusta, Georgia, United States