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

• Status: Terminated
• Trial end date: 2019-07-03
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this 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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Collaborator: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Ipilimumab; Nivolumab

Criteria

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) performance status of 0 or 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