Feasibility and Safety Study of Nivolumab With Irinotecan for Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT04173325|
Recruitment Status : Terminated (Closed by the IRB 5/26/22 due to non-compliance)
First Posted : November 21, 2019
Last Update Posted : June 14, 2022
|Condition or disease||Intervention/treatment||Phase|
|Small-cell Lung Cancer Small Cell Lung Carcinoma||Drug: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] Drug: Irinotecan Injection [Camptosar]||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||January 6, 2020|
|Actual Primary Completion Date :||May 26, 2022|
|Actual Study Completion Date :||May 26, 2022|
Experimental: 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)
Drug: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]
PD-1 inhibitor approved by the US FDA for treatment of patients with lung cancer.
Drug: Irinotecan Injection [Camptosar]
Chemotherapy drug currently FDA approved for treatment of multiple tumors, including small cell lung cancer.
- 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 ]CTCAE v.4.0. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
- Overall response rate [ Time Frame: through study completion, an average of 1 year ]Tumor response evaluation with RECIST
- Progression-free survival (PFS) [ Time Frame: through study completion, an average of 1 year ]PFS as measured from start of therapy till disease progression.
- Overall survival (OS) [ Time Frame: through study completion, an average of 1 year. ]OS as measured from start of therapy till date of death or last follow up assessment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04173325
|United States, Georgia|
|Georgia Cancer Center at AU Medical Center|
|Augusta, Georgia, United States, 30912|
|Principal Investigator:||Nagla A Karim, MD, PhD||Augusta University Georgia Cancer Center|