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New treatment option for Ewing Sarcoma
Official title Personalized Vaccination in Fusion+ Sarcoma Patients (PerVision)
ClinicalTrials.gov ID: NCT06094101
What this study is testing
What is Peptide vaccine IPX?
Peptide vaccine IPX is an investigational medicine, being studied as a potential treatment for ewing sarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The PerVision trial utilizes an approach of a patient-individual cancer vaccine with sarcoma-specific peptides in metastasized fusion-driven sarcoma patients determined by next generation whole exome sequencing of tumor and normal tissue as well as RNA sequencing of the tumor. This approach is applicable to all patients independent of the expression of distinct tumor associated antigens, and independent of their human leukocyte antigen-typing (HLA-typing).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 40
You may be able to join if
- , definition of partial remission plus (PRplus)
- Screening Stage 1:
- Confirmed metastatic fusion-driven rhabdomyosarcoma, Ewing- and synovial sarcoma in first or second complete remission (CR) or partial response (PR)...
- Whole exome sequencing and RNA sequencing data of the gene fusion (fusion-breakpoint RNA sequence) must be available by registration to the INFORM...
- Screening stage 2:
You likely can't join if
- Ejection fraction \< 25%
- Creatinine-clearance \< 40ml/min
- Bilirubin \> 4mg/dl
- Alanine aminotransferase (ALT) \> 400 units (U)/l and/or aspartate aminotransferase (AST) \> 400 U/l
- Severe infection (Human immunodeficiency virus (HIV): positive for the presence of human immunodeficiency virus-1 or human immunodeficiency virus-2...
- people with a known hypersensitivity / allergy to any component of the study drugs.
See the full eligibility criteria
- , definition of partial remission plus (PRplus)
- Screening Stage 1:
- Confirmed metastatic fusion-driven rhabdomyosarcoma, Ewing- and synovial sarcoma in first or second complete remission (CR) or partial response (PR) after local therapy and intensive standard chemotherapy protocols.
- Whole exome sequencing and RNA sequencing data of the gene fusion (fusion-breakpoint RNA sequence) must be available by registration to the INFORM (Individualized therapy for relapsed malignancies in childhood), MASTER...
- Screening stage 2:
- Design and production of the patient-individual vaccine cocktail was successful
- Patients have reached a complete or stable partial remission (CR or PR) the end of adjuvant and/or maintenance cytotoxic treatment. Cytotoxic treatment as per standard or trial recommendations has been completed...
- Ejection fraction \< 25%
- Creatinine-clearance \< 40ml/min
- Bilirubin \> 4mg/dl
- Alanine aminotransferase (ALT) \> 400 units (U)/l and/or aspartate aminotransferase (AST) \> 400 U/l
- Severe infection (Human immunodeficiency virus (HIV): positive for the presence of human immunodeficiency virus-1 or human immunodeficiency virus-2 (positive antigen/antibody or nucleic acid tests [NAT]) and...
- people with a known hypersensitivity / allergy to any component of the study drugs.
- people who have received a live, attenuated vaccine within 28 days prior to the administration of the study drug (only stage 2).
- people with a prior haematopoietic stem cell transplantation / prior organ transplantation.
- Patients suffering from other malignancies (with the exception of those with a negligible risk of metastasis or death and treated with curative outcome) within 5 years prior to study start.
- Current or anticipated need for any of the following medications interfering with T cell function from 14 days before 1st vaccination until 28 days after 1st vaccination: Immunosuppressive agents, which influence...
- Significant psychiatric disabilities that, in the judgment of the investigator, do not assure reliable participation in the present study.
- Uncontrolled seizure disorders (occurrence of at least one generalized seizure in the last 3 months) or severe peripheral neuropathy/leucoencephalopathy (\> grade 2 according to NCI CTCAE v5.0 neurotoxicity criteria).
- Autoimmune disease (e.g. idiopathic thrombocytopenic purpura, autoimmune hemolytic anemia, autoimmune dermatitis) requiring immunosuppressive treatment
- Pregnant females
- Female people of childbearing potential (postmenarcheal, with an intact uterus and at least one ovary, and less than one year postmenopausal) not agreeing to use acceptable method(s) of contraception from 30 days prior...
- Male people of reproductive capacity not agreeing to use effective contraception from first vaccination of this study to 180 days after the last vaccination.
- Not willing and/or not able to comply with treatment plan, scheduled visits, laboratory tests, contraceptive guidelines and other study procedures.
- History of any illness or clinical condition that might confound the results of the study or pose an additional risk in administering study drug to the subject, according to the judgement of the investigator. This may...
- Karnofsky performance status of \< 70% for people ≥ 16 years of age, Lansky performance status of \< 70% for people \< 16 years of age
- Participation or intended participation in another clinical phase I or II trial with an investigational drug or product within 28 days prior to enrollment (with the exception to participation of the "frontline and...
The study team makes the final eligibility decision.
Where it's taking place
- Essen, Germany
- Frankfurt am Main, Germany
- Freiburg im Breisgau, Germany
- Tübingen, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Essen, Germany; Frankfurt am Main, Germany; Freiburg im Breisgau, Germany; Tübingen, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.