Pemetrexed and Avelumab in Treating Patients With MTAP-Deficient Metastatic Urothelial Cancer
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|ClinicalTrials.gov Identifier: NCT03744793|
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : December 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Infiltrating Bladder Urothelial Carcinoma Sarcomatoid Variant Infiltrating Bladder Urothelial Carcinoma With Glandular Differentiation Infiltrating Bladder Urothelial Carcinoma With Squamous Differentiation Infiltrating Bladder Urothelial Carcinoma, Micropapillary Variant Infiltrating Bladder Urothelial Carcinoma, Plasmacytoid Variant Metastatic Urothelial Carcinoma MTAP Negative||Drug: Avelumab Drug: Pemetrexed||Phase 2|
I. To evaluate the response rate (RR) in patients with (methylthioadenosine phosphorylase) MTAP-deficient metastatic urothelial cancer treated sequentially with pemetrexed and avelumab.
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).
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial to Evaluate Combination Therapy With Pemetrexed and Avelumab in Previously Treated Patients With MTAP-Deficient Advanced Urothelial Cancer|
|Actual Study Start Date :||April 11, 2019|
|Estimated Primary Completion Date :||January 31, 2021|
|Estimated Study Completion Date :||January 31, 2021|
Experimental: Treatment (pemetrexed, avelumab)
Patients receive pemetrexed 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.
- Overall response rate [ Time Frame: Up to 2 years ]Will be defined as the number of subjects with a best response of complete response or partial response at any protocol evaluation by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria divided by the total numbers of subjects receiving their first dose of trial therapy.
- Progression free survival [ Time Frame: Time from the trial entry to the first documented tumor progression as determined by the investigator using the RECIST v1.1 criteria or death from any cause, whichever occurs first, assessed up to 2 years ]Will be presented using Kaplan-Meier estimates.
- Overall survival [ Time Frame: Time from treatment start date until death from any cause (event) or last contact date for patients last known to be alive (censor), assessed up to 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03744793
|Contact: Amishi Shahemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Amishi Y. Shah 713-792-2830|
|Principal Investigator: Amishi Y. Shah|
|Principal Investigator:||Amishi Y Shah||M.D. Anderson Cancer Center|