Feasibility and Safety Study of Nivolumab With Irinotecan for Small Cell Lung Cancer

June 10, 2022 updated by: Nagla Abdel Karim, Augusta University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Georgia Cancer Center at AU Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
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.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate
Time Frame: through study completion, an average of 1 year
Tumor response evaluation with RECIST
through study completion, an average of 1 year
Progression-free survival (PFS)
Time Frame: through study completion, an average of 1 year
PFS as measured from start of therapy till disease progression.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augusta University

Investigators

  • Principal Investigator: Nagla A Karim, MD, PhD, Augusta University Georgia Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2020

Primary Completion (Actual)

May 26, 2022

Study Completion (Actual)

May 26, 2022

Study Registration Dates

First Submitted

November 14, 2019

First Submitted That Met QC Criteria

November 20, 2019

First Posted (Actual)

November 21, 2019

Study Record Updates

Last Update Posted (Actual)

June 14, 2022

Last Update Submitted That Met QC Criteria

June 10, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCC-20-009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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