Feasibility and Safety Study of Nivolumab With Irinotecan for Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Phase I Feasibility and Safety Study of Nivolumab in Combination With Irinotecan in Relapsed or Refractory Small Cell Lung Cancer (SCLC) Followed by Maintenance Nivolumab

Conditions
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Small-cell Lung Cancer, Small Cell Lung Carcinoma

Intervention / Treatment
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* Drug: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]
* Drug: Irinotecan Injection [Camptosar]


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nivolumab and Irinotecan<br>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) | Drug: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]<br>* PD-1 inhibitor approved by the US FDA for treatment of patients with lung cancer.<br>Drug: Irinotecan Injection [Camptosar]<br>* Chemotherapy drug currently FDA approved for treatment of multiple tumors, including small cell lung cancer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the frequency and severity of adverse events in patients with small cell lung cancer after receiving nivolumab plus irinotecan followed by nivolumab maintenance. | CTCAE v.4.0. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate | Tumor response evaluation with RECIST | through study completion, an average of 1 year | 
| Progression-free survival (PFS) | PFS as measured from start of therapy till disease progression. | through study completion, an average of 1 year | 
| Overall survival (OS) | OS as measured from start of therapy till date of death or last follow up assessment. | through study completion, an average of 1 year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung cancer, Relapsed lung cancer