Description:
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.
Title
- Brief Title: Feasibility and Safety Study of Nivolumab With Irinotecan for Small Cell Lung Cancer
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
GCC-20-009
- NCT ID:
NCT04173325
Conditions
- Small-cell Lung Cancer
- Small Cell Lung Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] | | Nivolumab and Irinotecan |
Irinotecan Injection [Camptosar] | | Nivolumab and Irinotecan |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Nivolumab and Irinotecan | Experimental | 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]
- Irinotecan Injection [Camptosar]
|
Eligibility Criteria
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Evaluate the frequency and severity of adverse events in patients with small cell lung cancer after receiving nivolumab plus irinotecan followed by nivolumab maintenance. |
Time Frame: | through study completion, an average of 1 year |
Safety Issue: | |
Description: | CTCAE v.4.0. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. |
Secondary Outcome Measures
Measure: | Overall response rate |
Time Frame: | through study completion, an average of 1 year |
Safety Issue: | |
Description: | Tumor response evaluation with RECIST |
Measure: | Progression-free survival (PFS) |
Time Frame: | through study completion, an average of 1 year |
Safety Issue: | |
Description: | PFS as measured from start of therapy till disease progression. |
Measure: | Overall survival (OS) |
Time Frame: | through study completion, an average of 1 year. |
Safety Issue: | |
Description: | OS as measured from start of therapy till date of death or last follow up assessment. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Augusta University |
Trial Keywords
- Lung cancer
- Relapsed lung cancer
Last Updated
August 3, 2021