Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New vaccine combo targets Hard-to-Treat blood cancers

NCT ID NCT03358719

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested a cancer vaccine (CDX-1401) along with an immune booster, chemotherapy, and an immunotherapy drug in 8 people with myelodysplastic syndrome (MDS) or low-blast acute myeloid leukemia (AML). The goal was to see if the combination is safe and helps the immune system fight cancer. Because it's a small phase 1 study, the main focus was on side effects, not on curing the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CDX-1401 (a vaccine targeting cancer cells), poly ICLC (immune booster), decitabine (chemotherapy), and nivolumab (immunotherapy)
What this could lead to
If successful, this combination could offer a new treatment option for people with certain blood cancers by helping the immune system attack cancer cells more effectively.
What could go wrong
This is a very early, small phase 1 trial with only 8 participants, so results may not apply broadly. Side effects from the drug combination are unknown and could be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

8 people

The number who actually took part.

Started

Mar 2018

Finished

Aug 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute myeloid leukemia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.