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Personalized cancer vaccine trial for rare skin cancer withdrawn before starting

NCT ID NCT05799612

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study aimed to find a safe dose of a custom-made mRNA vaccine for people with a rare skin cancer called cutaneous angiosarcoma. The vaccine was designed to train the immune system to attack the cancer. However, the trial was withdrawn before any participants were enrolled.

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.

Started

Mar 2024

Expected to finish

Nov 2024

An estimate. End dates often move.

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: 1. Patients with histologically confirmed cutaneous head \& neck angiosarcoma deemed to be potentially resectable and who are deemed to be good candidates for postoperative therapy with radiation and study treatment. 2. Should be willing to undergo biopsy to provide fresh frozen tumor tissue for use in the creation of the vaccine. 3. 18 years of age or older and able to provide informed consent. 4. Adequate kidney, liver, bone marrow function, and immune function, as follows: * Hemoglobin ≥ 8.0 gm/dL * Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3 * Lymphocytes ≥ 500 cells/mm3 * Platelet count ≥ 75,000 /mm3 * CD4+ T-cell counts ≥ 200/mm3 * Glomerular filtration rate (GFR) \> 60 mL/min/m2 * For males = (140 - age\[years\]) x (body weight \[kg\]) (72) x (serum creatinine \[mg/dL\] * For females = 0.85 x male value * Total bilirubin ≤ 1.5 times upper limit of normal (ULN), * Aspartate transaminase AST (SGOT) and alanine aminotransferase ALT (SGPT) ≤ 2.5 times the ULN * TSH range between 0.4 - 4.0 mIU / L * aPTT or INR ≤ 1.5 × ULN unless subject is receiving anticoagulant therapy. If receiving anticoagulant therapy, patient is eligible as long as prothrombin time, international normalized ratio (INR), or activated partial thromboplastin time is within therapeutic range of intended use of anticoagulants 5. ECOG performance status ≤ 2. Exclusion criteria: 1. Locally advanced tumors deemed unresectable and/or metastatic tumors 2. Received live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, BCG, and typhoid vaccine. 3. Uncontrolled HIV infection with CD4+ \<200 c ells/µl or active HBC or HCV disease that requires antiviral therapy. 4. Need for concurrent therapy with corticosteroids or any systemic immunosuppressive agents during the vaccination phase of the study. 5. History of systemic autoimmune disease 6. Female patients who are pregnant, breast feeding, or of childbearing potential without a negative pregnancy test prior to baseline. Male or female patients of childbearing potential unwilling to use contraceptive precautions (refer Table 1) throughout the trial and 3 months following discontinuation of study treatment. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Women of childbearing potential must have a negative serum pregnancy test prior to the first treatment. 7. Concurrent participation on another therapeutic clinical trial. 8. Patients unwilling or unable to comply with the protocol or provide informed consent.

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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.

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