Ignite Creation Date:
2024-05-06 @ 7:08 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02478099
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2015-05-21
Brief Title:
MPDL3280A-treatment-IST-UMCG
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
MPDL3280A Treatment in Patients With Locally Advanced or Metastatic Solid Tumors After or During Investigational Imaging
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To be able to evaluate the investigational imaging - 89Zr-MPDL3280A-PET 89Zr-CD8 imaging and 18F-FB-IL2-PET - as complementary tools for selection of patients to be treated with MPDL3280A within this treatment trial the investigators will assess safety tolerability and anti-tumor activity of MPDL3280A in cancer patients who have undergone investigational imaging
Detailed Description:
Encouraging clinical data emerging in the field of tumor immunotherapy have demonstrated that therapies focused on enhancing T cell responses against cancer can result in a significant survival benefit in patients with Stage IV cancer PD-L1 is an extracellular protein that downregulates immune responses primarily in peripheral tissues through binding to its two receptors PD-1 and B7-1 Interruption of the PD L1PD-1 pathway by the PD-L1 targeting antibody MPDL3280A represents an attractive strategy to reinvigorate tumor-specific T cell immunity For PD1PD-L1 pathway inhibition PD-L1 tumor surface expression was proposed as a potential biomarker In early clinical trials PD-L1 expression has been associated with response to PD1PD-L1 inhibition However other clinical trials reported response to PD1PD-L1 checkpoint inhibitors in a big patient groups who were PD-L1-negative assessed by a single biopsy Another obstacle to using PD-L1 expression as predictive biomarker might be its potential heterogeneous expression and fast dynamics PD-L1 tumor expression and whole body distribution as well as baseline activation status of the immune system are being assessed in three investigational imaging trials MPDL3280A-img-042015 89Zr-CD8 imaging or IL2-img--UMCG-2015
To be able to evaluate the investigational imaging - 89Zr-MPDL3280A-PET 89Zr-CD8 imaging and 18F-FB-IL2-PET - as complementary tools for selection of patients to be treated with MPDL3280A within this treatment trial we will assess safety tolerability and anti-tumor activity of MPDL3280A in cancer patients who have undergone investigational imaging Acquired data could lead to improved more patient friendly more easily accessible and possibly less expensive procedures for patient selection Subsequently the efficacy of combinations of checkpoint inhibition could also be improved thus preventing unnecessary toxicity and reducing health care costs
To be able to evaluate the investigational imaging - 89Zr-MPDL3280A-PET 89Zr-CD8 imaging and 18F-FB-IL2-PET - as complementary tools for selection of patients to be treated with MPDL3280A within this treatment trial we will assess safety tolerability and anti-tumor activity of MPDL3280A in cancer patients who have undergone investigational imaging Acquired data could lead to improved more patient friendly more easily accessible and possibly less expensive procedures for patient selection Subsequently the efficacy of combinations of checkpoint inhibition could also be improved thus preventing unnecessary toxicity and reducing health care costs
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