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

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Augusta University

Status and phase

Terminated
Phase 1

Conditions

Small-cell Lung Cancer
Small Cell Lung Carcinoma

Treatments

Drug: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]
Drug: Irinotecan Injection [Camptosar]

Study type

Interventional

Funder types

Other

Identifiers

NCT04173325
GCC-20-009

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Nivolumab and Irinotecan
Experimental group
Description:
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)
Treatment:
Drug: Irinotecan Injection [Camptosar]
Drug: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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