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American Family Children's Hospital

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Protocol No. UW17007

Principal Investigator Leal, Ticiana

Phase I/II

Age Group Adult

Scope National

Sponsor Type Industry

Title A Phase 1/2 Study on the Safety of Rovalpituzumab Tesirine Administered in Combination with Nivolumab or Nivolumab and Ipilimumab for Adults with Extensive-Stage Small Cell Lung Cancer

Objective The purpose of this study is to test whether or not rovalpituzumab tesirine combined with nivolumab alone or with nivolumab and ipilimumab are useful treatments for small cell lung cancer (SCLC), after at least one prior treatment has failed.

Treatment Rovalpituzumab tesirine is an investigational drug. "Investigational" means the drug being tested has not been approved by any regulatory authority, for example, the United States Food and Drug Administration (FDA) - for the treatment of SCLC. Rovalpituzumab tesirine (SC16LD6.5) is a type of drug called an antibody-drug conjugate (ADC). Rovalpituzumab tesirine is made up of a monoclonal antibody that is linked to a very powerful form of chemotherapy. The monoclonal antibody specifically binds to a protein called delta-like protein 3 (DLL3), which can be found on the surface of small cell lung cancer cells. Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the body's immune system to work against tumor cells. Ipilimumab is a type of drug called a monoclonal antibody and it may help your immune system slow or stop the growth of cancer cells.

Description You will be enrolled into one of three cohorts (groups).Cohort 1 will receive rovalpituzumab tesirine and nivolumab; cohorts 2 and 3 will receive rovalpituzumab tesirine, nivolumab, and ipilimumab. Rovalpituzumab tesirine,nivolumab and ipilimumab are given (IV) (through your veins). All subjects will receive dexamethasone which is taken by mouth.

Key Eligibility
  • Histologically or cytologically confirmed extensive-stage SCLC with PD after at least one platinum-based chemotherapeutic regimen
  • Must have measurable disease
  • Availability of representative baseline tumor tissue (archived or on-study biopsy) suitable for immunohistochemistry testing
  • ECOG performance status of 0 or 1
  • Asymptomatic central nervous system (CNS) metastases, if present, must be stable, with or without previous treatment, in the absence of corticosteroids for at least 2 weeks prior to initiation of study drugs
  • At least two (2) weeks since last dose of any prior systemic anticancer therapy (e.g. chemotherapy, radiation, and/or surgery)
  • Adult 18 years of age or older
  • Patients with prior treatment with or exposure to a pyrrolobenzodiazepine (PBD)-based drug, other monoclonal antibodies, antibody drug conjugates(ADC), radioimmmunoconjugates, T-cell or other cell-based or biologic therapies or experimental anti-tumor vaccines are ineligible
  • Patients with documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms within 6 months prior to their first dose of study drugs are ineligible
  • Patients with known seropositivity for or active infection by human immunodeficiency virus (HIV), active hepatitis B or active hepatitis C are ineligible
  • Patients with previous malignancies are ineligible unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period
  • Patients with active, known, or suspected autoimmune disease are ineligible
  • Female subject who is pregnant, breastfeeding, or is considering becoming pregnant during the study or for approximately 31 weeks after the last dose of study drugs are ineligible

Applicable Disease Sites Lung

Therapies Involved Immunotherapy; Other

Drugs Involved BMS-936558 (Nivolumab); Nivolumab; Opdivo (Nivolumab); Rovalpituzumab tesirine; SC16LD6.5 (Rovalpituzumab tesirine); Yervoy (ipilimumab); ipilimumab

Status Open

Participating Institutions UW Hospital and Clinics