Immune Checkpoint Inhibition With Lurbinectedin Relapsed/Recurrent SCLC

Part of paid clinical trials in Kissimmee, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT04610658
Phase
PHASE1
Status
Terminated

Conditions

  • Recurrent Small Cell Lung Cancer
  • Relapsed Small Cell Lung Cancer
  • Small-cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Participants will receive 1 mg/kg Nivolumab on Day 1 of each treatment cycle for 4 cycles (induction immunotherapy). After 4 treatment cycles, Nivolumab will be continued at a flat dose of 360 mg.
  • Ipilimumab — DRUG
    Participants will receive 3mg/kg Ipilimumab on Day 1 of each treatment cycle for 4 cycles (induction immunotherapy). After 4 cycles, Ipilimumab will be discontinued.
  • Lurbinectedin — DRUG
    Participants will be treated at 1 of 3 dose levels of Lurbinectedin, beginning at 1.5 mg/m\^2 and increasing to 3.2 mg/m\^2 or the Maximum Tolerated Dose (MTD)

Study Details

This is a single-arm, phase I/II trial to determine the Maximum Tolerated Dose (MTD), Recommended Phase II Dose (RP2D), and the safety and efficacy of the combination of nivolumab-ipilimumab plus lurbinectedin in patients with relapsed/recurrent small cell lung cancer after progression with first-line, platinum-based chemotherapy

Key Dates

Start date
Nov 23, 2020
Status verified
Apr 2024
Primary completion
Mar 24, 2023
Completion
Mar 24, 2023

Study Design

Enrollment
9 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Dose Level 1: Nivolumab and Ipilimumab plus Lurbinectedin
    Participants will be treated at dose level 1: nivolumab 1mg/kg, ipilimumab 3mg/kg plus 1.5 mg/m\^2 lurbinectedin. Participants will receive nivolumab, ipilimumab and Lurbinectedin every 3 weeks for 4 cycles. After 4 treatment cycles, ipilimumab will be discontinued and participants will continue treatment with a flat dose of 360 mg nivolumab and Lurbinectedin at dose level 1 every 3 weeks.
  • Experimental: Phase 1 Dose Level 2: Nivolumab and Ipilimumab plus Lurbinectedin
    Participants will be treated at dose level 2: nivolumab 1mg/kg, ipilimumab 3mg/kg plus 2.6 mg/m\^2 lurbinectedin. Participants will receive nivolumab, ipilimumab and Lurbinectedin every 3 weeks for 4 cycles. After 4 treatment cycles, ipilimumab will be discontinued and participants will continue treatment with a flat dose of 360 mg nivolumab and Lurbinectedin at dose level 2 every 3 weeks.
  • Experimental: Phase 1 Dose Level 3: Nivolumab and Ipilimumab plus Lurbinectedin
    Participants will be treated at dose level 3: nivolumab 1mg/kg, ipilimumab 3mg/kg plus 3.2 mg/m\^2 lurbinectedin. Participants will receive nivolumab, ipilimumab and Lurbinectedin every 3 weeks for 4 cycles. After 4 treatment cycles, ipilimumab will be discontinued and participants will continue treatment with a flat dose of 360 mg nivolumab and Lurbinectedin at dose level 3 every 3 weeks.

Primary Outcome Measure

Phase 1: Maximum Tolerated Dose (MTD) of Lurbinectedin with Nivolumab and Ipilimumab [ Time Frame: Up to 12 weeks per cohort ]

Locations (2)

FacilityCityStateZIPSite coordinators
Advent Health - CelebrationKissimmeeFlorida34747-
Moffitt Cancer CenterTampaFlorida33612-

Find similar trials in Kissimmee, FL

By research site
Advent Health - Celebration· Kissimmee, FLMoffitt Cancer Center· Tampa, FL

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