A Study of Rovalpituzumab Tesirine Administered in Combination With Nivolumab and With or Without Ipilimumab for Adults With Extensive-Stage Small Cell Lung Cancer

  • Interventional
  • Recruiting
  • NCT03026166
Eligibility Details Visit Clinicaltrials.gov

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

The purpose of this multicenter, Phase 1/2, open-label, study is to assess the safety and efficacy of rovalpituzumab tesirine administered in combination with nivolumab or nivolumab and ipilimumab in participants with extensive-stage small cell lung cancer (SCLC).

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Participants with histologically or cytologically confirmed extensive-stage small cell lung cancer (SCLC) with progressive disease after at least one platinum-based chemotherapeutic regimen and with evaluable or measurable disease

         - Eastern Cooperative Oncology Group (ECOG) 0-1

         - Adequate hematologic, hepatic, and renal function

        Exclusion Criteria:

         - Has active, known, or suspected autoimmune disease

         - Had prior exposure to an immuno-oncology or pyrrolobenzodiazepine (PBD)-based drug

At a Glance

National Government IDNCT03026166

IRB#IRB17-0273

Lead SponsorAbbVie

Lead PhysicianJyoti Patel

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting