NCT03358719 · REGISTRY CONDITION SEARCH

DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Decitabine, and Nivolumab in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1
Status at capture: COMPLETED
Registry last update: 2026-02-27

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Proportion or Participants Experiencing a Dose-limiting Toxicity

→

outcome · POSTED

Immune Cell Profile

→

outcome · POSTED

Peripheral Blood and Bone Marrow Cells Responses

→

outcome · NOT POSTED

Complete Response Rate

→

outcome · NOT POSTED

Partial Response Rate

→

outcome · NOT POSTED

Hematologic Improvement

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: 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 excess blasts in transformation * Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 * Hepatic: * Total bilirubin =\< 3 X upper limit of normal (ULN) (except subjects with Gilbert syndrome, who can have total bilirubin up to 3.5 X ULN) * Aspartate aminotransferase (aspartate transaminase \[AST\]/serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (alanine transaminase \[ALT\]/serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 X ULN * Serum creatinine =\< 2.5 X ULN * Troponin-I =\< ULN * Creatine kinase (CK)-MB =\< ULN * Left ventricular ejection fraction (LVEF) \>= ULN (institutional limit) * Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure * No prior exposure to Nivolumab * No prior investigational therapy within 2 weeks prior to study enrollment Exclusion Criteria: * We will exclude patients who are eligible for an allogeneic bone marrow transplant at the time of study enrollment; if an enrolled patient subsequently becomes eligible for transplant, they will not be prevented from proceeding to the appropriate clinical treatment indicated * Subjects with life-threatening illnesses other than MDS, uncontrolled medical conditions or organ system dysfunction which, in the investigator?s opinion, could compromise the subject?s safety, or put the study outcomes at risk * AML associated with inv(16); t(16;16); t(8;21) or t(15;17) * Previously untreated MDS with isolated del5q (for which lenalidomide is approved as approved therapy) and chronic myelomonocytic leukemia (CMML) with rearrangements of the PDGF receptor (for which imatinib is approved therapy) unless they have previously failed these approaches * Subjects with symptomatic central nervous system (CNS) disease which is not adequately controlled * Subjects who have received prior radiation therapy for extramedullary disease within 2 weeks of first dose * Has known immunosuppressive disease (e.g. human immunodeficiency virus \[HIV\], acquired immunodeficiency syndrome \[AIDS\] or other immune depressing disease); testing is not required, only to be done for a possible diagnosis which is not confirmed * 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: * Myocardial infarction or arterial or venous thromboembolic events within 6 months prior to baseline or severe or unstable angina, New York Heart Association (NYHA) class III or IV disease * Active congestive heart failure (New York Heart Association functional classification III or IV) * Documented history of cardiomyopathy with EF \< 30% * Uncontrolled hypertension (systolic blood pressure \[SBP\] \> 160/diastolic blood pressure \[DBP\] \> 100 despite medical intervention) * History of myocarditis of any etiology * Subjects who have hypersensitivity to decitabine, CDX-1401, poly-ICLC or nivolumab * History of auto-immune disease (e.g., thyroiditis, lupus), except vitiligo * Pregnant or nursing female subjects * Unwilling or unable to follow protocol requirements * Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug * Regular use of immunosuppressant drugs such as steroids (\> 20 mg prednisone equivalents), azathioprine, tacrolimus, cyclosporine, etc\>. Use is not permitted within 4 weeks before recruitment
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Biological: DEC-205/NY-ESO-1 Fusion Protein CDX-1401
Drug: Decitabine
Other: Laboratory Biomarker Analysis
Biological: Nivolumab
Drug: Poly ICLC
label
Treatment (CDX-1401, poly ICLC, decitabine, nivolumab)
type
EXPERIMENTAL

interventions

arm Group Labels
Treatment (CDX-1401, poly ICLC, decitabine, nivolumab)
description
Given intracutaneously
name
DEC-205/NY-ESO-1 Fusion Protein CDX-1401
other Names
CDX-1401
type
BIOLOGICAL
arm Group Labels
Treatment (CDX-1401, poly ICLC, decitabine, nivolumab)
description
Given IV
name
Decitabine
other Names
5-Aza-2'-deoxycytidine
Dacogen
Decitabine for Injection
Deoxyazacytidine
Dezocitidine
type
DRUG
arm Group Labels
Treatment (CDX-1401, poly ICLC, decitabine, nivolumab)
description
Correlative studies
name
Laboratory Biomarker Analysis
type
OTHER
arm Group Labels
Treatment (CDX-1401, poly ICLC, decitabine, nivolumab)
description
Given IV
name
Nivolumab
other Names
BMS-936558
MDX-1106
NIVO
ONO-4538
Opdivo
type
BIOLOGICAL
arm Group Labels
Treatment (CDX-1401, poly ICLC, decitabine, nivolumab)
description
Given SC
name
Poly ICLC
other Names
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
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 8
type: ACTUAL

Registered outcome plans (not posted results)

other Outcomes

description
Will be assessed by complete response (CR), using results of blood counts on day 1 of each cycle.
measure
Complete Response Rate
time Frame
Up to 180 days
description
Will be assessed by partial response (PR) using results of blood counts on day 1 of each cycle.
measure
Partial Response Rate
time Frame
Up to 180 days
description
Will be assessed by Hematologic Improvement using results of blood counts on day 1 of each cycle
measure
Hematologic Improvement
time Frame
Up to 180 days

primary Outcomes

description
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.
measure
Proportion or Participants Experiencing a Dose-limiting Toxicity
time Frame
Up to 180 days

secondary Outcomes

description
Descriptive statistics will be used to evaluate the Immune cell profile in the peripheral blood and bone marrow following combination therapy using mass cytometry.
measure
Immune Cell Profile
time Frame
Up to 180 days
description
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.
measure
Peripheral Blood and Bone Marrow Cells Responses
time Frame
Cycle 1- 4 weekly to EOT (up to 180 days from baseline)

Full study description

brief Summary: 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.
detailed Description: 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.

Source references

references

citation
Griffiths EA, Srivastava P, Gomez EC, Matsuzaki J, Odunsi K, Dillon LW, Mukherjee D, Hourigan CS, Peng J, Bandyopadhyay S, Tan K, Attwood KM, Kuechle JB, Singh PK, Wang J, Nemeth MJ. Checkpoint immunotherapy is associated with preferential activation of tumor antigen-specific CD4+ T cells in MDS. Blood Neoplasia. 2025 Apr 25;2(3):100106. doi: 10.1016/j.bneo.2025.100106. eCollection 2025 Aug.
pmid
40809194
type
DERIVED

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-bd551ce91e59482e93cf
requested nct id
NCT03358719
primary nct id
NCT03358719
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Juvenile+Myelomonocytic+Leukemia&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
cddcd4e3a59550bc78924062a298c359d8f811413f73f4a4461963aecf3790d6
payload sha256
a95ac11dad6e51fa2618d708a5df384e3212b60f051cac2e417eabf266cdb182
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-bd551ce91e59482e93cf
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT03358719
occurrences
context exact
NCT03358719
end
11
exact text
NCT03358719
start
0
offset unit
unicode_code_points
query cond
Juvenile Myelomonocytic Leukemia
query disease state id
ds-juvenile-myelomonocytic-leukemia
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-juvenile-myelomonocytic-leukemia-000.json
source file sha256
cddcd4e3a59550bc78924062a298c359d8f811413f73f4a4461963aecf3790d6
source json pointer
/studies/8/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
2d1103bd29099a67387a56be0dd7c256bf5bde4d535d95b29a1c6e8c1c20165b
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Juvenile+Myelomonocytic+Leukemia&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice