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

Phase 1

• Conditions: Extensive-Stage Small Cell Lung Cancer; MedDRA version: 21.1Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-003686-26-IT
• Lead Sponsor: ABBVIE STEMCENTRX LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-07-03
• Study Start: 2020-11-23
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

-Minimum of 18 years old
-Participants with histologically 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54

Exclusion Criteria

-Has active, known, or suspected autoimmune disease
-Had prior exposure to an immuno-oncology or pyrrolobenzodiazapine (PBD)-based drug

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified