Azacitidine and Pembrolizumab in Treating Patients With Myelodysplastic Syndrome
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|ClinicalTrials.gov Identifier: NCT03094637|
Recruitment Status : Recruiting
First Posted : March 29, 2017
Last Update Posted : May 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|High Risk Myelodysplastic Syndrome IPSS Risk Category Intermediate-1 Myelodysplastic Syndrome||Drug: Azacitidine Biological: Pembrolizumab||Phase 2|
I. To assess the safety of the combination of azacitidine and MK3475 (pembrolizumab) in patients with higher risk myelodysplastic syndrome (MDS).
II. To explore the clinical activity (response, survival effect) of the combination of azacitidine with MK-3475 in patients with higher risk MDS.
I. To study the biological effects of the combination of azacitidine and pembrolizumab in patients with MDS treated on this study.
Patients receive azacitidine intravenously (IV) over 10-40 minutes or subcutaneously (SC) on days 1-7, and pembrolizumab IV over 30 minutes every 3 weeks. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up within 30 days, every 12 weeks for 1 year, then annually thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of the Combination of Azacitidine and Pembrolizumab for Patients With MDS|
|Actual Study Start Date :||November 6, 2017|
|Estimated Primary Completion Date :||November 30, 2021|
|Estimated Study Completion Date :||November 30, 2022|
Experimental: Treatment (azacitidine, pembrolizumab)
Patients receive azacitidine IV over 10-40 minutes or SC on days 1-7, and pembrolizumab IV over 30 minutes every 3 weeks. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
- Overall response rate (ORR) defined as complete response + partial response + hematological improvement [ Time Frame: After course 6 ]Will estimate the ORR for the experimental treatments, along with the 95% credible intervals. The association between ORR and patient's clinical characteristics will be examined by Wilcoxon's rank sum test or Fisher's exact test, as appropriate.
- Incidence of adverse events [ Time Frame: Up to 4 years ]Safety data of the patients will be summarized using descriptive statistics such as mean, standard deviation, median and range. Toxicity type, severity and attribution will be summarized for each patient using frequency tables.
- Event free survival [ Time Frame: Up to 4 years ]Will be estimated using the method of Kaplan and Meier. Comparisons of time-to-event endpoints by important subgroups will be made using the log-rank tests.
- Overall survival [ Time Frame: Up to 4 years ]Will be estimated using the method of Kaplan and Meier. Comparisons of time-to-event endpoints by important subgroups will be made using the log-rank tests.
- Immunological and molecular changes [ Time Frame: Baseline up to 4 years ]Paired t-tests will be used to determine the immunological and molecular changes in the peripheral blood and bone marrow from baseline to the time of response, and to the time of disease progression.
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): NCT03094637
|Contact: Guillermo Garcia-Manerofirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Guillermo Garcia-Manero 713-745-3428|
|Principal Investigator: Guillermo Garcia-Manero|
|Principal Investigator:||Guillermo Garcia-Manero||M.D. Anderson Cancer Center|