A Phase 1 interventional study of DEC-205/NY-ESO-1 Fusion Protein CDX-1401 and Decitabine in Acute Myeloid Leukemia, Blasts 30 Percent or Less of Bone Marrow Nucleated Cells and Chronic Myelomonocytic Leukemia, sponsored by Roswell Park Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Roswell Park Cancer Institute · Phase 1, Interventional, and Treatment
This phase I trial studies the side effects of DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, decitabine, and nivolumab in treating patients with myelodysplastic syndrome or acute myeloid leukemia. DEC-205/NY-ESO-1 fusion protein CDX-1401 is a vaccine that may help the immune system specifically target and kill cancer cells. Poly ICLC may help stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as nivolumab, may interfere with the ability of cancer cells to grow and spread. Giving DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, decitabine, and nivolumab may work better in treating patients with myelodysplastic syndrome or acute myeloid leukemia.
PRIMARY OBJECTIVES:
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).
SECONDRY OBJECTIVES:
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.
TERTIARY OBJECTIVES:
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.
OUTLINE:
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 30 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.
3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
This study's enrollment of 8 is below the median of 40 across 3,005 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →Roswell Park Cancer Institute is the lead sponsor of 419 studies on the registry; 65 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Have a confirmed diagnosis of:
Exclusion Criteria:
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; in addition, subjects will be excluded for any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: DEC-205/NY-ESO-1 Fusion Protein CDX-1401 · Drug: Decitabine · Other: Laboratory Biomarker Analysis · Biological: Nivolumab · Drug: Poly ICLC
Drug page: Rasdegafusp alfa
Given intracutaneously
Also known as: CDX-1401
Given IV
Also known as: 5-Aza-2'-deoxycytidine, Dacogen, Decitabine for Injection, Deoxyazacytidine, Dezocitidine
Correlative studies
Given IV
Also known as: BMS-936558, MDX-1106, NIVO, ONO-4538, Opdivo
Given SC
Also known as: Hiltonol, Poly I:Poly C with Poly-L-Lysine Stabilizer, poly-ICLC, PolyI:PolyC with Poly-L-Lysine Stabilizer, Polyinosinic-Polycytidylic Acid Stabilized with Polylysine and Carboxymethylcellulose, Polyriboinosinic-Polyribocytidylic Acid-Polylysine Carboxymethylcellulose, Stabilized Polyriboinosinic/Polyribocytidylic Acid
Proportion or Participants Experiencing a Dose-limiting Toxicity
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.
Time frame: Up to 180 days
Immune Cell Profile
Descriptive statistics will be used to evaluate the Immune cell profile in the peripheral blood and bone marrow following combination therapy using mass cytometry.
Time frame: Up to 180 days
Peripheral Blood and Bone Marrow Cells Responses
The degree of DNA methylation at CpG sites within the promoter of the tumor antigen NY-ESO-1 was quantified. Results are reported as the percentage of methylated cytosines relative to the total cytosines at the analyzed CpG sites.
Time frame: Cycle 1- 4 weekly to EOT (up to 180 days from baseline)
Complete Response Rate
Will be assessed by complete response (CR), using results of blood counts on day 1 of each cycle.
Time frame: Up to 180 days
Partial Response Rate
Will be assessed by partial response (PR) using results of blood counts on day 1 of each cycle.
Time frame: Up to 180 days
Hematologic Improvement
Will be assessed by Hematologic Improvement using results of blood counts on day 1 of each cycle
Time frame: Up to 180 days
| Milestone | Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab) |
|---|---|
| Started | 8 |
| Completed | 3 |
| Not completed | 5 |
| Withdrew: Physician decision | 1 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Adverse event | 2 |
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.
| percentage of participants | Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab) |
|---|---|
| Proportion or Participants Experiencing a Dose-limiting Toxicity | 0.0 |
Descriptive statistics will be used to evaluate the Immune cell profile in the peripheral blood and bone marrow following combination therapy using mass cytometry.
| percentage of CD45⁺ leukocytes | Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab) |
|---|---|
| Pre Conventional dendritic cells type 1 (Cycle 1) | 0.0030201667 ± 0.0050996289 |
| Pre Conventional dendritic cells type 2 (Cycle 2) | 0.152785 ± 0.1900236337 |
| Pre Plasmacytoid dendritic cells (Cycle 1) | 0.1246616667 ± 0.1795932594 |
| Post Conventional dendritic cells type 1 (Cycle1) | 0.0038176667 ± 0.0054418615 |
| Post Conventional dendritic cells type 2 (Cycle 2) | 0.1421666667 ± 0.1900236337 |
| Post Plasmacytoid dendritic cells (Cycle 2) | 0.0837116667 ± 0.1795932594 |
The degree of DNA methylation at CpG sites within the promoter of the tumor antigen NY-ESO-1 was quantified. Results are reported as the percentage of methylated cytosines relative to the total cytosines at the analyzed CpG sites.
| percentage of methylated cytosines | Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab) |
|---|---|
| Baseline (Day 0) | 84.5 ± 4.9 |
| Cycle 1 Week 1 (approximately 1 week from baseline) | 81 ± 7.8 |
| Cycle 1 Week 2 (approximately 2 weeks from baseline) | 70.2 ± 9.3 |
| Cycle 1 Week 3 (approximately 3 weeks from baseline) | 73.5 ± 0.71 |
| Cycle 1 Week 4 (approximately 4 weeks from baseline) | 76.6 ± 6.8 |
| Cycle 2 Week 1 (approximately 5 weeks from baseline) | 85.1 ± 5.5 |
| Cycle 2 Week 2 (approximately 6 weeks from baseline) | 62.3 ± 13.7 |
| Cycle 2 Week 3 (approximately 7 weeks from baseline) | 72 ± 9.3 |
| Cycle 2 Week 4 (approximately 8 weeks from baseline) | 76.9 ± 8.5 |
| Cycle 3 Week 1 (approximately 9 weeks from baseline) | 82.5 ± .71 |
| Cycle 3 Week 2 (approximately 10 weeks from baseline) | 54.1 ± 24.3 |
| Cycle 3 Week 3 (approximately 11 weeks from baseline) | 74.3 ± 2.8 |
| Cycle 4 Week 1 (approximately 12 weeks from baseline) | 72.4 ± 12.4 |
| Cycle 4 Week 2 (approximately 13 weeks from baseline) | 59.7 ± 12.4 |
| Cycle 4 Week 3 (approximately 14 weeks from baseline) | 76 ± 5.5 |
| Cycle 4 Week 4 (approximately 15 weeks from baseline) | 76.3 ± 11.7 |
| End of Treatment (up to 180 days from baseline) | 85.7 ± 1.5 |
Will be assessed by complete response (CR), using results of blood counts on day 1 of each cycle.
Results for this outcome have not been posted.
Will be assessed by partial response (PR) using results of blood counts on day 1 of each cycle.
Results for this outcome have not been posted.
Will be assessed by Hematologic Improvement using results of blood counts on day 1 of each cycle
Results for this outcome have not been posted.
Collected over 180 days after the last treatment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab) | 6/8 (75%) | 6/8 (75%) | 6/8 (75%) |
| Event | Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab) |
|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 2/8 |
| DeathGeneral disorders | 1/8 |
| Immune system disorderImmune system disorders | 1/8 |
| Lung infectionInfections and infestations | 1/8 |
| SepsisInfections and infestations | 1/8 |
| SinusitisInfections and infestations | 1/8 |
| Skin infectionInfections and infestations | 1/8 |
| Subdural haematomaInjury, poisoning and procedural complications | 1/8 |
| PresyncopeNervous system disorders | 1/8 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/8 |
| Event | Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab) |
|---|---|
| AnaemiaBlood and lymphatic system disorders | 3/8 |
| Oedema peripheralGeneral disorders | 3/8 |
| FallInjury, poisoning and procedural complications | 3/8 |
| Decreased appetiteMetabolism and nutrition disorders | 3/8 |
| HypoalbuminaemiaMetabolism and nutrition disorders | 3/8 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 3/8 |
| FatigueGeneral disorders | 2/8 |
| Alanine aminotransferase increasedInvestigations | 2/8 |
| Aspartate aminotransferase increasedInvestigations | 2/8 |
| HypokalaemiaMetabolism and nutrition disorders | 2/8 |
All treated and eligible patients
| Age, Categorical(Participants) | Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 7 |
| Age, Continuous(years) | Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab) |
|---|---|
| Mean | 72.2 ± 8.6 |
| Sex: Female, Male(Participants) | Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab) |
|---|---|
| Female | 3 |
| Male | 5 |
| Race (NIH/OMB)(Participants) | Treatment (CDX-1401, Poly ICLC, Decitabine, Nivolumab) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 7 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2018 to primary completion in Feb 2020, 23 months.
Results were first posted in Feb 2026, 6 years after primary completion.
Of 305 non-industry phase 1 interventional studies under Leukemia, Myeloid, Acute, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 87. This study's 23 months is below that.
Counting every sponsor, half of 488 studies reached it within 49 months; a quarter within 31 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Rasdegafusp alfa · Poly ICLC
Roswell Park Cancer Institute →