DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Decitabine, and Nivolumab in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT03358719|
Recruitment Status : Recruiting
First Posted : December 2, 2017
Last Update Posted : March 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Blasts 30 Percent or Less of Bone Marrow Nucleated Cells Chronic Myelomonocytic Leukemia High Risk Myelodysplastic Syndrome Myelodysplastic Syndrome Refractory Anemia||Biological: DEC-205/NY-ESO-1 Fusion Protein CDX-1401 Drug: Decitabine Other: Laboratory Biomarker Analysis Biological: Nivolumab Drug: Poly ICLC||Phase 1|
I. Evaluate the safety of NY-ESO-1 vaccination (Anti-DEC-205-NY-ESO-1 fusion protein + poly-ICLC) given in combination with decitabine 20 mg/m^2 intravenously and nivolumab 3 mg/kg in patients with myelodysplastic syndrome (MDS) or low blast count acute myeloid leukemia (AML).
I. Assess immune and molecular epigenetic responses following combination therapy with nivolumab, decitabine and NY-ESO-1 fusion protein CDX-1401 (NY-ESO-1) vaccination.
I. To record the response rate (complete response, partial response and hematological improvement) in MDS or low blast count AML patients treated with the combination in order to provide descriptive characteristics.
II. To record the overall survival (OS), progression free survival (PFS) and time to AML transformation (TTT) (for patients with MDS at diagnosis) enrolled on the study.
Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 intracutaneously and poly ICLC subcutaneously (SC) on day -14, on day 15 of courses 1-4, and then on day 1 of every 4 courses thereafter. Patients also receive nivolumab intravenously (IV) over 60 minutes on days 1 and 15 and decitabine IV over 1 hour on days 1-5. Courses with nivolumab and decitabine repeat every 4 weeks in the absence of disease progression or unaccepted toxicity.
After completion of study treatment, patients are followed up at 30, 60, 90, and 180 days.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of DEC205mAb-NY ESO 1 Fusion Protein (CDX-1401) Given With Adjuvant Poly-ICLC in Conjunction With 5-Aza-2'Deoxycytidine (Decitabine) and Nivolumab in Patients With MDS or Low Blast Count AML|
|Actual Study Start Date :||March 27, 2018|
|Estimated Primary Completion Date :||September 13, 2019|
|Estimated Study Completion Date :||September 13, 2020|
Experimental: Treatment (CDX-1401, poly ICLC, decitabine, nivolumab)
Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 intracutaneously and poly ICLC SC on day -14, on day 15 of courses 1-4, and then on day 1 of every 4 courses thereafter. Patients also receive nivolumab IV over 60 minutes on days 1 and 15 and decitabine IV over 1 hour on days 1-5. Courses with nivolumab and decitabine repeat every 4 weeks in the absence of disease progression or unaccepted toxicity.
Biological: DEC-205/NY-ESO-1 Fusion Protein CDX-1401
Other Name: CDX-1401
Other: Laboratory Biomarker Analysis
Drug: Poly ICLC
- Incidence of adverse events [ Time Frame: Up to 180 days ]Will evaluate the proportion of n=12 evaluable patients in the expansion cohort experiencing a dose-limiting toxicity. Toxicity rates will be described using upper 1-sided 95% Jeffreys binomial confidence intervals.
- Immune cell profile [ Time Frame: Up to 180 days ]Descriptive statistics will be used to evaluate the Immune cell profile in the peripheral blood and bone marrow following combination therapy using mass cytometry.
- Peripheral blood and bone marrow cells responses [ Time Frame: Up to 180 days ]Will determine the impact of combination treatment on peripheral blood and bone marrow cells from patients treated in this manner on NY-ESO-1 target gene expression, NY-ESO-1 protein expression, NY-ESO-1 promoter methylation, and global deoxyribonucleic acid (DNA) methylation. The statistical significance of the change in marker values resulting from treatment will be assessed using the (paired sample) Wilcoxon Signed Rank test.
- Complete Response rate [ Time Frame: Up to 180 days ]Will be assessed by complete response (CR), using results of blood counts on day 1 of each cycle.
- Partial Response Rate [ Time Frame: Up to 180 days ]Will be assessed by partial response (PR) using results of blood counts on day 1 of each cycle.
- Hematologic Improvement [ Time Frame: Up to 180 days ]Will be assessed by Hematologic Improvement using results of blood counts on day 1 of each cycle
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): NCT03358719
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263|
|Contact: Elizabeth A. Griffiths 716-845-3996 Elizabeth.Griffiths@roswellpark.org|
|Principal Investigator: Elizabeth A. Griffiths|
|Principal Investigator:||Elizabeth Griffiths||Roswell Park Cancer Institute|