Clinical Trial: NCT04173325 - My Cancer Genome

NCT04173325

Description:

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.

Related Conditions:

Small Cell Lung Carcinoma

Recruiting Status:

Recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT04173325

Trial Eligibility

Document

Title

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

Clinical Trial IDs

ORG STUDY ID: GCC-20-009
NCT ID: NCT04173325

Conditions

Small-cell Lung Cancer
Small Cell Lung Carcinoma

Interventions

Drug	Synonyms	Arms
Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]		Nivolumab and Irinotecan
Irinotecan Injection [Camptosar]		Nivolumab and Irinotecan

Purpose

Trial Arms

Name	Type	Description	Interventions
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)	Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] Irinotecan Injection [Camptosar]

Eligibility Criteria

        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.

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

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

Secondary Outcome Measures

Measure:	Overall response rate
Time Frame:	through study completion, an average of 1 year
Safety Issue:
Description:	Tumor response evaluation with RECIST

Measure:	Progression-free survival (PFS)
Time Frame:	through study completion, an average of 1 year
Safety Issue:
Description:	PFS as measured from start of therapy till disease progression.

Measure:	Overall survival (OS)
Time Frame:	through study completion, an average of 1 year.
Safety Issue:
Description:	OS as measured from start of therapy till date of death or last follow up assessment.

Details

Phase:	Phase 1
Primary Purpose:	Interventional
Overall Status:	Recruiting
Lead Sponsor:	Augusta University

Trial Keywords

Lung cancer
Relapsed lung cancer

Last Updated

August 3, 2021

Clinical Trials /

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