Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03358719 | DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Decitabine, and Nivolumab in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia | PHASE1 | COMPLETED | 8 | — | — | Mar 27, 2018 | Aug 25, 2021 | Feb 27, 2026 | 1 | United States |
Will evaluate the proportion of n=8 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.
| Arm | Type | Description |
|---|---|---|
| Treatment (CDX-1401, poly ICLC, decitabine, nivolumab) | EXPERIMENTAL | Patients receive 1mg/1.8mg 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 3mg/kg nivolumab IV over 30 minutes on days 1 and 15 and 20 mg/m2 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. |
| Name | Type | Description |
|---|---|---|
| DEC-205/NY-ESO-1 Fusion Protein CDX-1401 | BIOLOGICAL | Given intracutaneously |
| Decitabine | DRUG | Given IV |
| Laboratory Biomarker Analysis | OTHER | Correlative studies |
| Nivolumab | BIOLOGICAL | Given IV |
| Poly ICLC | DRUG | Given SC |
Inclusion Criteria: * Have a confirmed diagnosis of: * International Prognostic Scoring System (IPSS) intermediate-1, intermediate-2 or high-risk MDS including chronic myelomonocytic leukemia (CMML) OR * Low blast count AML with =\< 30% blasts previously classified as refractory anemia with ex...