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TerminatedPhase 1NCT04173325
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNivolumab 10 MG/ML Intravenous Solution [OPDIVO] and Irinotecan Injection [Camptosar]

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC) · Recurrent or relapsed · Resistant or refractory

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 14, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Augusta University

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Augusta University
Interventions being studied
Drug: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]; Drug: Irinotecan Injection [Camptosar]
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Small cell lung cancer (SCLC)→
Disease setting
Recurrent or relapsed→Resistant or refractory→
Treatment approach
Immunotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion criteria
  • Patients with UGT1A polymorphism.
  • Currently receiving chemotherapy.
  • Pregnant and nursing women.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Georgia Cancer Center at AU Medical CenterAugusta, Georgia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 14, 2022. Always confirm current availability with the study team.

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