Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT03455556
Status:
TERMINATED
Last Update Posted:
2023-01-06
First Post:
2018-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Anetumab Ravtansine and Atezolizumab in Treating Participants With Advanced Non-small Cell Lung Cancer
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
Phase I/II Study of the Human Anti-Mesothelin Antibody Drug Conjugate Anetumab Ravtansine (AR), Combined With the PD-L1 Inhibitor Atezolizumab in Non-Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I/II trial studies the best dose and side effects of anetumab ravtansine when given together with atezolizumab and how well they work in treating participants with non-small cell lung cancer that has spread to other places in the body. Monoclonal antibodies, such as anetumab ravtansine and atezolizumab, may interfere with the ability of tumor cells to grow and spread.
Detailed Description:
PRIMARY OBJECTIVES:
I. To identify the recommended phase II dose of anetumab ravtansine combined with atezolizumab in advanced MSLN+ non-small cell lung cancer (NSCLC). (Phase I) II. To determine the confirmed response rate for the combination of anetumab ravtansine and atezolizumab in MSLN+ 2nd line NSCLC. (Phase II)
SECONDARY OBJECTIVES:
I. To describe adverse events and toxicities of the combination treatment of anetumab ravtansine and atezolizumab. (Phase I) II. To identify preliminary evidence of clinical activity (i.e. response, timed endpoints, etc.) (Phase I) III. To determine the progression-free survival (PFS) and the 1-year PFS rate for the combination of anetumab ravtansine and atezolizumab in 2nd-line NSCLC. (Phase II) IV. To determine the overall survival of anetumab ravtansine combined with atezolizumab in second-line therapy of NSCLC. (Phase II) V. Adverse events will also be summarized as well. (Phase II)
CORRELATIVE OBJECTIVES:
I. To determine using flow cytometry the levels of Bcl-2 interacting mediator of cell death (BIM) in circulating CD8+ CD11a+ PD-1+ T-cells, in peripheral blood samples collected from patients prior to initiation of therapy (baseline) and correlating these with confirmed response rate during and following treatment with the combination regimen.
II. To determine tissue MSLN and PD-L1 expression and correlate with response to combination therapy with atezolizumab and anetumab ravtansine.
III. To correlate baseline serum soluble PDL-1 (sPDL-1) with response to therapy.
OUTLINE: This is a phase I, dose-escalation study of anetumab ravtansine followed by a phase II study.
Participants receive anetumab ravtansine intravenously (IV) over 60 minutes and atezolizumab IV over 30-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up every 3 months for up to 2 years.
I. To identify the recommended phase II dose of anetumab ravtansine combined with atezolizumab in advanced MSLN+ non-small cell lung cancer (NSCLC). (Phase I) II. To determine the confirmed response rate for the combination of anetumab ravtansine and atezolizumab in MSLN+ 2nd line NSCLC. (Phase II)
SECONDARY OBJECTIVES:
I. To describe adverse events and toxicities of the combination treatment of anetumab ravtansine and atezolizumab. (Phase I) II. To identify preliminary evidence of clinical activity (i.e. response, timed endpoints, etc.) (Phase I) III. To determine the progression-free survival (PFS) and the 1-year PFS rate for the combination of anetumab ravtansine and atezolizumab in 2nd-line NSCLC. (Phase II) IV. To determine the overall survival of anetumab ravtansine combined with atezolizumab in second-line therapy of NSCLC. (Phase II) V. Adverse events will also be summarized as well. (Phase II)
CORRELATIVE OBJECTIVES:
I. To determine using flow cytometry the levels of Bcl-2 interacting mediator of cell death (BIM) in circulating CD8+ CD11a+ PD-1+ T-cells, in peripheral blood samples collected from patients prior to initiation of therapy (baseline) and correlating these with confirmed response rate during and following treatment with the combination regimen.
II. To determine tissue MSLN and PD-L1 expression and correlate with response to combination therapy with atezolizumab and anetumab ravtansine.
III. To correlate baseline serum soluble PDL-1 (sPDL-1) with response to therapy.
OUTLINE: This is a phase I, dose-escalation study of anetumab ravtansine followed by a phase II study.
Participants receive anetumab ravtansine intravenously (IV) over 60 minutes and atezolizumab IV over 30-60 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up every 3 months for up to 2 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: