A phase I trial of actively personalized peptide vaccinations plus immunomodulators in patients with newly diagnosed glioblastoma concurrent to first line temozolomide maintenance therapy

Completed

• Conditions: glioblastoma and brain tumor; 10029211

• Registration Number: NL-OMON44016
• Lead Sponsor: immatics biotechnologies GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

1. Histologically confirmed, newly diagnosed GB (astrocytoma WHO grade IV)
2. HLA phenotype defined by warehouse composition (HLA-A*02:01 or HLA-A*24:02 positive patients only)
3. Gross total resection (as defined by less than 1 cm² residual tumor mass on the largest perpendicular axes in post-operative scan taken within 48 h post-surgery; standard MRI conformable to the present national and international guidelines is sufficient)
4. At least 0.5 g tumor tissue freshly cryopreserved during surgery (equivalent to at least 3 pea-sized tumor pieces). Note: a higher amount of collected tumor tissue is desirable and may increase the quality of the APVAC vaccine
5. Age: *18 years
6. KPS *70%
7. Life expectancy > 6 months
8. Patients is a candidate for and willing to receive standard CRT with TMZ followed by maintenance TMZ chemotherapy cycles
9. Patients not on steroids or on stable or decreasing steroid levels not exceeding 2 mg/day dexamethasone (or equivalent doses of other steroids) during the last 3 days prior to enrollment
10. ALC > 1.0 x 109/L (re-screening of lymphocyte counts is allowed)
11. Ability of subject to understand and the willingness to sign written informed consent for study participation. Written consent by a legally authorized representative is not sufficient.
12. Availability of an APVAC analysis and manufacturing slot confirmed by the sponsor
13. Female patients who are post-menopausal (no menstrual period for a minimum of 1 year), or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or practice a highly effective method of birth control, i.e. resulting in a failure rate of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner (ref. to ICH M3).
14. Male patients willing to use contraception (condoms with spermicidal jellies or cream) upon study entry and during the course of the study, have undergone vasectomy or are practicing total abstinence.

Exclusion Criteria

1. Abnormal (* Grade 2 CTCAE v4.0) laboratory values for hematology (Hb, WBC, neutrophils, and platelets), liver (serum bilirubin, ALAT, ASAT, and GGT) and renal function (serum creatinine).
2. HIV infection or active Hepatitis B or C infection, or active infections requiring oral or intravenous antibiotics or that can cause a severe disease and pose a severe danger to lab personnel working on patients* blood or tissue (e.g. rabies).
3. Prior therapy for glioma (except surgery and steroids) including but not limited to carmustine wafers and immunotherapy. Note: History of low grade glioma that did not require prior treatment with chemotherapy or radiotherapy is not an exclusion criterion.
4. Any condition contraindicating leukapheresis from peripheral veins.
5. Concurrent participation in another interventional clinical trial studying a drug or treatment regimen.
6. Clinically relevant autoimmune diseases (with the exception of thyroid diseases).
7. Patients with known hypersensitivity/allergy to any component of the APVAC vaccines, GM-CSF or poly-ICLC (e.g. carboxymethylcellulose).
8. Immunosuppression, not related to prior treatment for malignancy.
9. Patients with prior stem cell transplantation or solid organ transplantation.
10. Any condition that in the judgment of the investigator interferes with the probability that an individual patient may receive and benefit from APVAC vaccinations (e.g. high risk of early disease progression / recurrence; immunocompromised status; anticipated compliance problems).
11. Serious illness or condition, which according to the investigator poses an undue risk for the patient when participating in the trial.
12. History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 5 years.
13. Pregnancy or breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified