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

Augusta University

Status and phase: Terminated; Phase 1

Conditions: Small-cell Lung Cancer; Small Cell Lung Carcinoma

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

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)

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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: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]

Drug: Irinotecan Injection [Camptosar]