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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
Information provided by (Responsible Party):
Nagla Abdel Karim, Augusta University

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: through study completion, an average of 1 year ]
    Tumor response evaluation with RECIST

  2. Progression-free survival (PFS) [ Time Frame: through study completion, an average of 1 year ]
    PFS as measured from start of therapy till disease progression.

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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

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United States, Georgia
Georgia Cancer Center at AU Medical Center
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Augusta University
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Principal Investigator: Nagla A Karim, MD, PhD Augusta University Georgia Cancer Center
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Responsible Party: Nagla Abdel Karim, Professor, Hematology/Oncology, Director of Thoracic Oncology and Phase I Program, Augusta University
ClinicalTrials.gov Identifier: NCT04173325    
Other Study ID Numbers: GCC-20-009
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: June 14, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nagla Abdel Karim, Augusta University:
Lung cancer
Relapsed lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors