Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616623
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Vismodegib and Atezolizumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase Ib Study of Vismodegib and Atezolizumab in Patients with Advanced Non-Small Cell Lung Cancer ML43922
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase Ib trial tests the safety side effects and best dose of the combination of vismodegib and atezolizumab in treating patients with non-small cell lung cancer NSCLC that has come back after a period of improvement recurrent or has spread from where it first started primary site to other places in the body metastatic Vismodegib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Immunotherapy with monoclonal antibodies such as atezolizumab may help the bodys immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread Giving a combination of vismodegib and atezolizumab may be safe tolerable andor effective than either drug alone in treating patients with recurrent or metastatic NSCLC
Detailed Description:
PRIMARY OBJECTIVE
I To determine the safety and tolerability of the combination of vismodegib and atezolizumab in patients with advanced NSCLC based upon the Common Terminology Criteria for Adverse Events CTCAE version 5 criteria
SECONDARY OBJECTIVE
I To determine the efficacy of the combination of vismodegib and atezolizumab in patients with advanced NSCLC including progression-free survival PFS objective response ORR disease control rate DCR and overall survival OS based on modified Response Evaluation Criteria in Solid Tumors RECIST version 11
EXPLORATORY OBJECTIVE
I To study the effect of vismodegib on the levels of M2-TAMs and CD8 T cells within the tumor microenvironment TME as well as myeloid-derived suppressor cells MDSCs in peripheral blood of study patients
OUTLINE
Patients receive vismodegib orally PO daily on days 1-28 and atezolizumab intravenously IV on day 1 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also undergo computed tomography CT or magnetic resonance imaging MRI and blood sample collection throughout the study Some patients undergo tissue sample collection during screening and on study
After completion of study treatment patients are followed up every 12 weeks
I To determine the safety and tolerability of the combination of vismodegib and atezolizumab in patients with advanced NSCLC based upon the Common Terminology Criteria for Adverse Events CTCAE version 5 criteria
SECONDARY OBJECTIVE
I To determine the efficacy of the combination of vismodegib and atezolizumab in patients with advanced NSCLC including progression-free survival PFS objective response ORR disease control rate DCR and overall survival OS based on modified Response Evaluation Criteria in Solid Tumors RECIST version 11
EXPLORATORY OBJECTIVE
I To study the effect of vismodegib on the levels of M2-TAMs and CD8 T cells within the tumor microenvironment TME as well as myeloid-derived suppressor cells MDSCs in peripheral blood of study patients
OUTLINE
Patients receive vismodegib orally PO daily on days 1-28 and atezolizumab intravenously IV on day 1 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity Patients also undergo computed tomography CT or magnetic resonance imaging MRI and blood sample collection throughout the study Some patients undergo tissue sample collection during screening and on study
After completion of study treatment patients are followed up every 12 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None