Back to resultsFeasibility and Safety Study of Nivolumab With Irinotecan for Small Cell Lung Cancer
Primary Purpose
Small-cell Lung Cancer, Small Cell Lung Carcinoma
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]
Irinotecan Injection [Camptosar]
Sponsored by
About this trial
This is an interventional treatment trial for Small-cell Lung Cancer focused on measuring Lung cancer, Relapsed lung cancer
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.
Sites / Locations
- Georgia Cancer Center at AU Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nivolumab and Irinotecan
Arm Description
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)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall response rate
Tumor response evaluation with RECIST
Progression-free survival (PFS)
PFS as measured from start of therapy till disease progression.
Overall survival (OS)
OS as measured from start of therapy till date of death or last follow up assessment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04173325
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Closed by the IRB 5/26/22 due to non-compliance
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
May 26, 2022 (Actual)
Study Completion Date
May 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Augusta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small-cell Lung Cancer, Small Cell Lung Carcinoma
Keywords
Lung cancer, Relapsed lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nivolumab and Irinotecan
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]
Intervention Description
PD-1 inhibitor approved by the US FDA for treatment of patients with lung cancer.
Intervention Type
Drug
Intervention Name(s)
Irinotecan Injection [Camptosar]
Intervention Description
Chemotherapy drug currently FDA approved for treatment of multiple tumors, including small cell lung cancer.
Primary Outcome Measure Information:
Title
Evaluate the frequency and severity of adverse events in patients with small cell lung cancer after receiving nivolumab plus irinotecan followed by nivolumab maintenance.
Description
CTCAE v.4.0. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Overall response rate
Description
Tumor response evaluation with RECIST
Time Frame
through study completion, an average of 1 year
Title
Progression-free survival (PFS)
Description
PFS as measured from start of therapy till disease progression.
Time Frame
through study completion, an average of 1 year
Title
Overall survival (OS)
Description
OS as measured from start of therapy till date of death or last follow up assessment.
Time Frame
through study completion, an average of 1 year.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nagla A Karim, MD, PhD
Organizational Affiliation
Augusta University Georgia Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgia Cancer Center at AU Medical Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Feasibility and Safety Study of Nivolumab With Irinotecan for Small Cell Lung Cancer
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