Marrow Infiltrating Lymphocytes - Non-Small Cell Lung Cancer (MILs™ - NSCLC) Alone or in Combination With Nivolumab With or Without Tadalafil in Locally Advanced and Unresectable or Metastatic NSCLC

Part of paid clinical trials in Duarte, California.

Sponsor
WindMIL Therapeutics
Study ID
NCT04069936
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • MILs™ - NSCLC — BIOLOGICAL
    To evaluate the safety of MILs™ - NSCLC alone in subjects with locally advanced and unresectable or metastatic NSCLC
  • nivolumab — BIOLOGICAL
    To evaluate the efficacy of MILs™ - NSCLC in combination with nivolumab in subjects with locally advanced and unresectable or metastatic NSCLC
  • tadalafil — DRUG
    To evaluate the efficacy of MILs™ - NSCLC in combination with nivolumab with or without tadalafil in subjects with locally advanced and unresectable or metastatic NSCLC

Study Details

The purpose of this study is to determine the safety and efficacy of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil in subjects with locally advanced and unresectable or metastatic NSCLC who are refractory or relapsing to a PD-1 containing regimen.

Key Dates

Start date
Oct 15, 2019
Status verified
Jul 2022
Primary completion
Oct 28, 2021
Completion
Nov 30, 2021

Study Design

Enrollment
19 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: MILs™ - NSCLC plus nivolumab with or without tadalafil
    Locally advanced and unresectable and metastatic NSCLC subjects previously treated with anti-programmed cell death-1 (PD-1) will be treated with MILs™ - NSCLC plus nivolumab with or without tadalafil.

Primary Outcome Measure

Adverse Events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0 [ Time Frame: From ICF through 100 days after the last dose of study treatment ]

Locations (10)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
University of California - Los AngelesLos AngelesCalifornia90095-
Moffitt Cancer CenterTampaFlorida33612-
Emory UniversityAtlantaGeorgia30322-
Karmanos Cancer CenterDetroitMichigan48201-
Washington UniversitySt LouisMissouri63110-
University of Nebraska Medical CenterOmahaNebraska68198-
Cleveland ClinicClevelandOhio44195-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Sarah Cannon Research InstituteNashvilleTennessee37203-

Find similar trials in Duarte, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
City of Hope· Duarte, CAUniversity of California - Los Angeles· Los Angeles, CAMoffitt Cancer Center· Tampa, FLEmory University· Atlanta, GAKarmanos Cancer Center· Detroit, MIWashington University· St Louis, MO

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