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

Part of paid clinical trials in Augusta, Georgia.

Sponsor
Augusta University
Study ID
NCT04173325
Phase
PHASE1
Status
Terminated

Conditions

  • Small Cell Lung Carcinoma
  • Small-cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jan 6, 2020
Status verified
Jun 2022
Primary completion
May 26, 2022
Completion
May 26, 2022

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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)

Primary Outcome 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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Georgia Cancer Center at AU Medical CenterAugustaGeorgia30912-

Find similar trials in Augusta, GA

By research site
Georgia Cancer Center at AU Medical Center· Augusta, GA

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