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Closed by the IRB 5/26/22 due to non-compliance
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] | Drug | PD-1 inhibitor approved by the US FDA for treatment of patients with lung cancer. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nagla A Karim, MD, PhD | Augusta University Georgia Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia Cancer Center at AU Medical Center | Augusta | Georgia | 30912 | United States |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Irinotecan Injection [Camptosar] | Drug | Chemotherapy drug currently FDA approved for treatment of multiple tumors, including small cell lung cancer. |
|
| 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. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |