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

Sponsor

Augusta University (Other)

Overall Status

Terminated

CT.gov ID

NCT04173325

Collaborator

(none)

Enrollment

Location

Arm

28.6

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Small-cell Lung Cancer Small Cell Lung Carcinoma	Drug: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] Drug: Irinotecan Injection [Camptosar]	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I Feasibility and Safety Study of Nivolumab in Combination With Irinotecan in Relapsed or Refractory Small Cell Lung Cancer (SCLC) Followed by Maintenance Nivolumab

Actual Study Start Date :

Jan 6, 2020

Actual Primary Completion Date :

May 26, 2022

Actual Study Completion Date :

May 26, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nivolumab and Irinotecan 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] 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.

Arm

Intervention/Treatment

Experimental: Nivolumab and Irinotecan

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]

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.

Outcome Measures

Primary Outcome Measures

Evaluate the frequency and severity of adverse events in patients with small cell lung cancer after receiving nivolumab plus irinotecan followed by nivolumab maintenance. [through study completion, an average of 1 year]
CTCAE v.4.0. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

Secondary Outcome Measures

Overall response rate [through study completion, an average of 1 year]
Tumor response evaluation with RECIST
Progression-free survival (PFS) [through study completion, an average of 1 year]
PFS as measured from start of therapy till disease progression.
Overall survival (OS) [through study completion, an average of 1 year.]
OS as measured from start of therapy till date of death or last follow up assessment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Georgia Cancer Center at AU Medical Center	Augusta	Georgia	United States	30912

Sponsors and Collaborators

Augusta University

Investigators

Principal Investigator: Nagla A Karim, MD, PhD, Augusta University Georgia Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nagla Abdel Karim, Professor, Hematology/Oncology, Director of Thoracic Oncology and Phase I Program, Augusta University

ClinicalTrials.gov Identifier:

NCT04173325

Other Study ID Numbers:

GCC-20-009

First Posted:

Nov 21, 2019

Last Update Posted:

Jun 14, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nagla Abdel Karim, Professor, Hematology/Oncology, Director of Thoracic Oncology and Phase I Program, Augusta University

Lung cancer

Relapsed lung cancer

Additional relevant MeSH terms:

Lung Neoplasms

Small Cell Lung Carcinoma

Nivolumab

Irinotecan

Study Results

No Results Posted as of Jun 14, 2022