Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Alliance Foundation Trials, LLC.
Study ID
NCT03656627
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab will be given as an IV infusion every two weeks, in an outpatient setting. One cycle is a 28-day period, with Nivolumab given on days 1 and 15 of a 28-day cycle. For each cohort, all patients will be dosed at 240 mg IV. There will be no dose de-escalation or escalation from this dose level.

Study Details

The purpose of this study is to explore the safety, tolerability and activity of Nivolumab, a PD-1 inhibitor, in cohorts of patients with autoimmune disease. Two cohorts of patients will be enrolled, based on autoimmune disease type. Patients will be screened within 28 days prior to the start of dosing. Eligible patients will be enrolled in either of the two cohorts. Patients will receive treatment every two weeks, in an outpatient setting. One cycle is a 28-day period, with Nivolumab given on days 1 and 15 of a 28-day cycle. Subjects will be permitted to continue treatment beyond initial RECIST 1.1.

Key Dates

Start date
Jun 27, 2019
Status verified
Feb 2023
Primary completion
Mar 18, 2021
Completion
Mar 18, 2021

Study Design

Enrollment
7 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab: Autoimmune Diseases Cohort 1
    Arms determined by autoimmune type. First cohort consists of patients with: Rheumatoid arthritis, psoriasis, giant cell arteritis/polymyalgia rheumatica, systemic lupus erythematosis If a patient has more than one autoimmune condition, if all the conditions are within either cohort 1 or 2 above, the patient will be assigned to that cohort. If the patient has conditions from both cohort 1 and 2, the patient will be grouped in cohort 2.
  • Experimental: Nivolumab: Autoimmune Diseases Cohort 2
    Arms determined by autoimmune type. Second cohort consists of patients with: Other autoimmune diseases (ulcerative colitis, Crohn's disease, multiple sclerosis). Patients must be discussed with PI prior to enrollment. If a patient has more than one autoimmune condition, if all the conditions are within either cohort 1 or 2 above, the patient will be assigned to that cohort. If the patient has conditions from both cohort 1 and 2, the patient will be grouped in cohort 2.

Primary Outcome Measure

Dose-Limiting Toxicity (DLT) [ Time Frame: 48 Months ]

Locations (9)

FacilityCityStateZIPSite coordinators
University of Chicago Medical CenterChicagoIllinois60637-
Massachusetts General HospitalBostonMassachusetts02114-
St. Joseph Mercy HospitalAnn ArborMichigan48106-
Metro Minnesota Community Oncology Research ConsortiumSaint Louis ParkMinnesota55416-
Dartmouth Hitchcock Norris Cotton Cancer CenterLebanonNew Hampshire03756-
The Ohio State University Wexner Medical Center - Thoracic Oncology ClinicColumbusOhio43210-
Providence Cancer Institute Franz ClinicPortlandOregon97213-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
University of Wisconsin Clinical Science CenterMadisonWisconsin53792-

Find similar trials in Chicago, IL

By condition
Crohn's diseaseMultiple sclerosisLung cancerPsoriasisRheumatoid arthritisLupus (SLE)Ulcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune diseaseNeurologyBrain disordersOncologyLung oncologyLung diseaseDermatologyRheumatologyMusculoskeletal disorders
By research site
University of Chicago Medical Center· Chicago, ILMassachusetts General Hospital· Boston, MASt. Joseph Mercy Hospital· Ann Arbor, MIMetro Minnesota Community Oncology Research Consortium· Saint Louis Park, MNDartmouth Hitchcock Norris Cotton Cancer Center· Lebanon, NHThe Ohio State University Wexner Medical Center - Thoracic Oncology Clinic· Columbus, OH

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