Ignite Creation Date:
2024-05-06 @ 12:21 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03744793
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-06
First Post:
2018-11-15
Brief Title:
Pemetrexed and Avelumab in Treating Patients with MTAP-Deficient Metastatic Urothelial Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Trial to Evaluate Combination Therapy with Pemetrexed and Avelumab in Previously Treated Patients with MTAP-Deficient Advanced Urothelial Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
This phase II trial studies how well pemetrexed and avelumab work in treating patients with MTAP-deficient urothelial cancer that has spread to other places in the body Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Immunotherapy with monoclonal antibodies such as avelumab may help the bodys immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread Giving pemetrexed and avelumab may work better in treating patients with MTAP-deficient urothelial cancer
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the response rate RR in patients with methylthioadenosine phosphorylase MTAP-deficient metastatic urothelial cancer treated sequentially with pemetrexed and avelumab
SECONDARY OBJECTIVES
I To estimate the progression-free survival PFS and overall survival OS in patients with MTAP-deficient metastatic urothelial cancer treated sequentially with pemetrexed and avelumab
II To explore the effect of pemetrexed - avelumab on the immune system and tumor microenvironment including peripheral T-cells tumor-infiltrating T-cells macrophages and myeloid-derived suppressor cells MDSCs
OUTLINE
Patients receive pemetrexed intravenously IV over 10 minutes on day 1 Starting cycle 2 patients also receive avelumab IV over 60 minutes Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 and 120 days and then every 3 months for 2 years
I To evaluate the response rate RR in patients with methylthioadenosine phosphorylase MTAP-deficient metastatic urothelial cancer treated sequentially with pemetrexed and avelumab
SECONDARY OBJECTIVES
I To estimate the progression-free survival PFS and overall survival OS in patients with MTAP-deficient metastatic urothelial cancer treated sequentially with pemetrexed and avelumab
II To explore the effect of pemetrexed - avelumab on the immune system and tumor microenvironment including peripheral T-cells tumor-infiltrating T-cells macrophages and myeloid-derived suppressor cells MDSCs
OUTLINE
Patients receive pemetrexed intravenously IV over 10 minutes on day 1 Starting cycle 2 patients also receive avelumab IV over 60 minutes Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 and 120 days and then every 3 months for 2 years
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2018-02517 | REGISTRY | None | None |
| 2018-0576 | OTHER | M D Anderson Cancer Center | None |