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Protocol No. UW18122

Principal Investigator Leal, Ticiana

Phase I

Age Group Adult

Scope National

Sponsor Type Industry

Title Safety, Activity, and Pharmacology of Nivolumab in Patients with Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease

Objective The purpose of this study is to determine how safe and tolerable nivolumab is in treating patients with advanced non-small cell lung cancer (NSCLC) who also have an autoimmune disease. The study will also look at how nivolumab works in patients with advanced NSCLC who also have an autoimmune disease.
The standard of care therapy for patients with advanced NSCLC is platinum based doublet therapy. This type of therapy is usually two chemotherapy drugs administered together as part of the treatment regimen for NSCLC. It is normally a combination of a platinum based chemotherapy drug and one other chemotherapy drug given through the vein. For patients whose cancer becomes worse after platinum-based chemotherapy, the standard approach to treatment is a single chemotherapy agent, or an immune therapy drug such as nivolumab

Treatment 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

Description A Phase I study for Safety, Activity, and Pharmacology of Nivolumab in Patients with Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease

Key Eligibility
  • Age at least 18
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Metastatic, locally advanced or recurrent NSCLC, not amenable to curative therapy
  • Patients should have received at least one platinum-based chemotherapy regimen for recurrent or metastatic disease or have received platinum-based chemotherapy as part of adjuvant or neoadjuvant therapy and experienced progression of disease within 6 months of completing therapy
  • Patients with tumor genetic alterations such as EGFR, ALK, ROS1 or BRAF V600E alterations for which there is FDA-approved targeted therapy must have been treated with the appropriate targeted inhibitors in prior therapy
  • No limit on number of prior therapies
  • Ability to provide written, informed consent
  • Patients must be on a stable regimen of treatment for their autoimmune condition without need for addition of new medications or escalating doses of preexisting medications in the previous 12 weeks prior to study entry
  • Adequate organ and marrow function as defined by the protocol
  • Can not be pregnant or breastfeeding
  • Male and Female of child bearing potential must agree to adequate birth control as defined by the protocol
  • Patients with autoimmune diseases must have baseline disease activity scores as defined by the protocol
    EXCLUSION:
  • No chemotherapy or radiotherapy within two weeks of study entry. Prior targeted therapy is allowed as long as at least 5 half-lives have elapsed since last dose
  • All adverse events (other than alopecia) from prior therapy must be resolved to Grade 1 or less
  • Patients who are known to be HIV positive are excluded due to the known immunologic alterations associated with the disease. HIV testing is not required
  • No uncontrolled intercurrent illness such as active infection, or psychiatric illness or social situation that in the judgment of the investigator would limit compliance with study requirements
  • No active interstitial lung disease (ILD) or pneumonitis, or a history of ILD or pneumonitis requiring treatment with corticosteroids
  • No live vaccine within 30 days of start of study treatment
  • No carcinomatous meningitis or untreated CNS metastases
  • No history of significant cardiac disease or presence of an abnormality in electrocardiograms that, in the investigator's opinion, is medically exclusionary or clinically meaningful
  • No other active malignancy
  • No known history of or positivity for active hepatitis B or C. HBV DNA and/or HCV RNA must be undetectable and HBsAg must be negative at the time of screening
  • No active unstable angina and/or congestive heart failure, or myocardial infarction within 6 months prior to protocol participation

  • Applicable Disease Sites Lung

    Status Open

    Participating Institutions UW Hospital and Clinics; UWCCC 1 South Park