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

NCT04173325 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-06-14

No results posted yet for this 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.

Conditions

  • Small-cell Lung Cancer
  • Small Cell Lung Carcinoma

Interventions

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.

Sponsors & Collaborators

  • Augusta University

    lead OTHER

Principal Investigators

  • Nagla A Karim, MD, PhD · Augusta University Georgia Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-06
Primary Completion
2022-05-26
Completion
2022-05-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04173325 on ClinicalTrials.gov