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Safety and Immunogenicity Study of IDH1 Peptide Vaccine and Vorasidenib in Adults with Recurrent IDH1R132H‑Mutant Astrocytoma (Grades 2‑4)

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on adults who have a brain tumor called recurrent IDH1R132H-mutant astrocytoma, grade 2‑4. Astrocytoma is a type of cancer that starts in cells that support the brain, and the IDH1R132H mutation is a tiny change in a gene that can help the tumor grow.

Participants receive a combination of two treatments: an oral tablet named Voranigo, which contains the medicine vorasidenib taken by mouth, and a subcutaneous injection called IDH1 peptide vaccine, which is given under the skin to help the immune system recognize the tumor. The tablet is taken daily, while the vaccine is given in a series of shots over several weeks.

The purpose of the trial is to determine whether this combination is safe and can stimulate an immune response against the tumor. After an initial period of treatment before any surgery (called neoadjuvant therapy), patients continue to receive the medicines after surgery (adjuvant therapy) while doctors monitor them with regular visits, blood tests, and imaging to watch for side effects and to see how the tumor responds.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and Baseline Assessments

    After agreeing to join the study, you will complete a set of baseline tests that may include imaging, blood work, and a review of your medical history to confirm eligibility.

    These assessments establish a reference point for later comparison of treatment effects.

  2. Step 2

    Start of Safety Lead‑In Phase (Weeks 1–13)

    You will begin taking vorasidenib as a 40 mg film‑coated tablet taken by mouth each day.

    At scheduled visits, you will receive an IDH1 vaccine administered as a 300 µg subcutaneous injection.

    Visits are labeled sV1 through sV13 and occur regularly during the 13‑week period to monitor safety and record any side effects.

    During each visit, clinical staff will check for injection‑site reactions, liver enzyme changes, and other signs of toxicity.

  3. Step 3

    Transition to Main Therapy Phase (Weeks 1–37)

    If the safety lead‑in phase is completed without unacceptable toxicity, you will continue daily oral vorasidenib at the same 40 mg dose.

    Additional doses of the IDH1 vaccine will be given by subcutaneous injection according to the study schedule, which spans visits V1 through V12.

    These visits occur over a 37‑week period and include regular assessments of safety, immune response, and tumor status.

    The same safety checks performed during the lead‑in phase continue, with particular attention to severe reactions such as grade 3 or 4 injection‑site inflammation, significant liver enzyme elevation, cerebral edema, or any event that could be life‑threatening.

  4. Step 4

    End‑of‑Treatment Evaluation

    At the conclusion of the 37‑week main therapy phase, you will undergo final imaging and laboratory tests to evaluate the overall effect of the combination treatment.

    The study team will assess whether the treatment was tolerated and will record any lasting side effects.

  5. Step 5

    Post‑Treatment Follow‑Up

    After the formal treatment period ends, you will be monitored at predefined intervals to track long‑term safety and disease status.

    Follow‑up visits may include blood tests and imaging to determine overall survival and progression‑free survival, as defined by the study criteria.

Who can join the trial?

20 criteria

  • You must be able to understand what the study involves and what will happen to you.
  • You need to have a normal immune system, meaning you are not taking high doses of steroids like dexamethasone (no more than 2 mg per day in the three days before starting the study).
  • Your overall health rating, measured by the Karnofsky Performance Status, must be 70 or higher (you can carry out most daily activities).
  • Your bone marrow must work well, shown by:
    • White blood cell count (called absolute neutrophil count) of at least 1.5 × 10⁹ per liter.
    • Hemoglobin (the protein that carries oxygen) of at least 9 grams per deciliter.
    • Platelet count (helps blood clot) of at least 100 × 10⁹ per liter.
    • Your kidneys must be functioning adequately, shown by a blood test for serum creatinine that is not more than twice the normal upper limit, or a creatinine clearance greater than 30 mL per minute.
    • Your liver must be functioning adequately, shown by:
      • Total bilirubin (a waste product processed by the liver) not more than 1.5 times the normal upper limit (higher limits apply if you have Gilbert’s syndrome).
      • Enzyme levels called ALT and AST that are at or below the normal upper limit.
      • Alkaline phosphatase (ALP) not more than 2.5 times the normal upper limit.
      • You must be post‑menopausal or otherwise unable to become pregnant. Women who could become pregnant must have a negative pregnancy test before treatment and use very effective birth control.
      • If you could become pregnant (or have a partner who could), you must agree to use two forms of birth control (a male condom plus another highly effective method) starting right after you sign the consent form and continue through the study and for six months after the last dose.
      • You must sign a written informed consent form agreeing to take part.
      • You must be 18 years of age or older.
      • You must have a confirmed repeat occurrence (first, second, or third) of an IDH1R132H‑mutated astrocytoma that is grade 2, 3, or 4, after having had radiation and chemotherapy.
      • You need a recent brain scan (MRI) of the tumor taken within the last three months.
      • You need a sample of tumor tissue from your most recent brain surgery (either preserved in a standard way or frozen).
      • You must have already received both radiotherapy (radiation treatment) and alkylating chemotherapy (a type of chemotherapy that damages DNA).
      • You must be at least six months past your last radiation treatment and at least four weeks past your last chemotherapy before the screening scan.
      • You must be a candidate for a planned surgical removal of tumor tissue (complete or partial) and be able to delay that surgery for up to six weeks if needed for the study.

Who cannot join the trial?

22 criteria

  • Presence of a genetic change called 1p19q co-deletion (a specific chromosome alteration) – you cannot have this.
  • Being pregnant or breastfeeding (lactation) – cannot join while pregnant or nursing.
  • Currently taking part in another interventional clinical trial (a study testing a new treatment) or have been in such a trial within the last 30 days – not allowed.
  • Having received any cancer medicines (other than surgery) within 4 weeks, or within 6 weeks if the medicine was a nitrosourea (a type of chemotherapy); also must wait at least 28 days after any previous experimental drug – not allowed.
  • Using medicines that suppress the immune system within 4 weeks before the study, except for certain steroid forms (nasal, inhaled, skin creams, low‑dose oral steroids, or steroids given before scans) – not allowed.
  • Having a history of or current infection with HIV, hepatitis B (HBV), or hepatitis C (HCV) – not allowed.
  • Having an active infection that needs treatment with medicines – not allowed.
  • Receiving a live, weakened vaccine (such as some flu or measles vaccines) within 4 weeks before the study drug – not allowed.
  • Having serious heart problems that are currently active, such as a stroke or brain attack within the last 6 months, a heart attack within the last 6 months, unstable chest pain (unstable angina), heart failure that is moderate to severe (New York Heart Association Class II or higher), or dangerous heart rhythm problems that need medication – not allowed.
  • Having other severe ongoing illnesses such as colitis, inflammatory bowel disease, lung inflammation (pneumonitis), lung scarring (pulmonary fibrosis), or serious mental health issues including recent or current thoughts of suicide – not allowed.
  • Having a heart‑rate‑adjusted QT interval that is too long (a measurement that can lead to dangerous heart rhythms), or conditions that increase this risk such as low potassium, family history of long QT, or certain heart block patterns – not allowed, unless a medical monitor approves.
  • Being unable to swallow pills – not allowed.
  • Having high‑risk brain tumor features judged by the doctor, such as the tumor involving the brainstem, major loss of brain function, or uncontrolled seizures (seizures that interfere with daily life and have not responded to three different medication plans) – not allowed.
  • Having another active cancer at the same time, except for a completely removed non‑melanoma skin cancer or a cancer that was only in situ and fully treated; other past cancers are allowed only if you have been cancer‑free for at least 3 years – not allowed otherwise.
  • Having a left ventricular ejection fraction (LVEF) lower than 40% on a recent heart ultrasound (echocardiogram) – this measures how well the heart pumps blood – not allowed.
  • Being unlikely to cooperate with the study procedures – not allowed.
  • Being allergic (hypersensitive) to any part of the study drug vorasidenib – not allowed.
  • Being allergic (hypersensitive) to any part of the study vaccine IDH1‑vac – not allowed.
  • Taking medicines that are processed by certain liver enzymes (CYP2C8, CYP2C9, CYP2C19, CYP3A) and have a very narrow safety range – not allowed.
  • Having a significant lactose intolerance that would affect taking the study medication – not allowed.
  • Having previously taken vorasidenib or any other drug that blocks mutant IDH proteins – not allowed.
  • Having previously received the IDH1 vaccine (IDH1‑vac) – not allowed.
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Investigated drugs

  • Voranigo

    is an oral tablet taken by mouth. It works by blocking a mutant enzyme (IDH1/2) that some brain tumors use to grow. By stopping this enzyme, the drug may help slow tumor growth and make the cancer easier to treat. In the trial the medication is given before and after surgery to see if it is safe and how well it works together with the vaccine.

  • IDH1 peptide vaccine

    is a small piece of the mutant IDH1 protein that is injected under the skin. The vaccine is meant to teach the patient’s immune system to recognize and attack tumor cells that have the IDH1R132H mutation. In the study it is given along with Voranigo to test safety and to see if it can trigger an immune response against the tumor.

What is already known about the treatment

  • Vorasidenib

    This medication is taken by mouth as a film‑coated tablet. It is still investigational and is being studied in clinical trials for brain tumors with IDH1 or IDH2 mutations. The main use is to treat recurrent IDH‑mutant astrocytoma, a type of brain cancer. It works by blocking the mutant IDH enzyme, which lowers the amount of a harmful substance that helps cancer grow, and it belongs to the class of targeted small‑molecule inhibitors.

  • IDH1 peptide vaccine

    This vaccine is given as a subcutaneous injection in a small emulsion. It is also experimental and is being tested in trials to see if it can safely trigger an immune response against tumors that carry the IDH1 R132H mutation. Its purpose is to treat recurrent IDH1‑mutant astrocytoma by teaching the body’s immune system to recognize and attack the cancer cells. The vaccine contains short pieces of the mutant IDH1 protein that stimulate immune cells, and it is classified as a therapeutic cancer vaccine.

Investigated diseases

Recurrent IDH1 R132H‑mutant astrocytoma, grade 2–4 - Astrocytoma is a brain tumor that develops from star‑shaped glial cells. The tumors in this study carry a specific change in the IDH1 gene known as the R132H mutation. They are classified as WHO grade 2, 3, or 4, reflecting increasing cellular abnormality and growth rate. “Recurrent” indicates that the tumor has returned or continued to grow after prior radiation and chemotherapy. Over time, the tumor can enlarge and spread into nearby brain tissue, leading to worsening neurological signs.
Trial detailsLast updated 13 Nov 2026
Age18+ yearsPhasePhase ITrial ID2026-526504-73-00Protocol codeUHD-iVOCALEstimated enrolment45 patientsSponsorHeidelberg University

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