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

NCT04173325 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: GCC-20-009
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lung cancer; Relapsed lung cancer

Outcome Measures

Primary Outcomes (1)

• Evaluate the frequency and severity of adverse events in patients with small cell lung cancer after receiving nivolumab plus irinotecan followed by nivolumab maintenance.

  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 Outcomes (3)

• Overall response rate

  through study completion, an average of 1 year

• Progression-free survival (PFS)

  through study completion, an average of 1 year

• Overall survival (OS)

  through study completion, an average of 1 year.

Study Arms (1)

Nivolumab and Irinotecan

EXPERIMENTAL

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]; Drug: Irinotecan Injection [Camptosar]

Interventions

Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] DRUG

PD-1 inhibitor approved by the US FDA for treatment of patients with lung cancer.

Nivolumab and Irinotecan

Irinotecan Injection [Camptosar] DRUG

Chemotherapy drug currently FDA approved for treatment of multiple tumors, including small cell lung cancer.

Nivolumab and Irinotecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with UGT1A polymorphism.
• Currently receiving chemotherapy.
• Pregnant and nursing women.

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Georgia Cancer Center at AU Medical Center

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Lung Neoplasms

Interventions

Nivolumab; Irinotecan

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Nagla A Karim, MD, PhD

  Augusta University Georgia Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Hematology/Oncology, Director of Thoracic Oncology and Phase I Program

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 21, 2019
• Study Start: January 6, 2020
• Primary Completion: May 26, 2022
• Study Completion: May 26, 2022
• Last Updated: June 14, 2022

Record last verified: 2022-06

Locations

US (1)