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Clinical Trials/EUCTR2017-003076-31-NL
EUCTR2017-003076-31-NL
Active, not recruiting
Phase 1

An open-label, Phase I/II multicenter clinical trial of VXM01 in combination with avelumab in patients with progressive glioblastoma following standard treatment with or without second surgery. - VXM01 plus Avelumab combination study in progressive glioblastoma

VAXIMM GmbH0 sites30 target enrollmentJune 6, 2018
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ConditionsProgressive glioblastoma (WHO grade IV)MedDRA version: 20.0 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsBavencio

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Progressive glioblastoma (WHO grade IV)
Sponsor
VAXIMM GmbH
Enrollment
30
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 6, 2018
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Subjects who are able to understand and follow instructions during the trial
  • •2\.Ability and willingness to give written informed consent, signed and dated
  • •3\.Male or female subjects. Female subjects must be post\-menopausal for at least 2 years or surgically sterile
  • •4\.Age \=18 years
  • •5\.Histologically diagnosed intracranial supratentorial malignant glioma (contrast\-enhancing glioblastoma WHO Grade IV)
  • •6\.Evidence of tumor progression by RANO criteria following at least one prior therapy regimen that must have contained radiation and chemotherapy with temozolomide, as measured by MRI
  • •?Raditotherapy must have been completed at least 3 months prior to the inclusion visit
  • •7\.Candidates for a tumor reoperation (for the resectable arm \[n\=6] only)
  • •?Neurosurgical intervention should be postponable for 30 days
  • •8\.Adequate bone marrow function including: Absolute neutrophil count (ANC) \=1,500/mm3 or \=1\.5 x 109/L; Platelets \= 100,000/mm3 or \=100 x 109/L; Hemoglobin \= 9 g/dL (may have been transfused); INR \<1\.5x ULN. Subjects with documented benign cyclical neutropenia are allowed if WBC count is \= 1\.5 × 109/L with absolute neutrophil count \= 1\.0 × 109/L and appropriate hematology parameters: leukocytes \=4\.0 x 109 / L, lymphocytes \=0\.6 x 109/L

Exclusion Criteria

  • •1\.Cardiovascular disease defined as:
  • •\- uncontrolled hypertension
  • •\- arterial thromboembolic event within 6 months before trial entry
  • •2\.Congestive heart failure New York Heart Association grade III to IV
  • •3\.Serious ventricular arrhythmia requiring medication and arrhythmias requiring ICD
  • •4\.Clinically significant peripheral artery disease \> grade 2b according to Fontaine
  • •5\.History of relevant intracranial hemorrhage
  • •6\.Hemoptysis within 6 months before trial entry
  • •7\.Known oesophageal varices
  • •8\.Upper or lower gastrointestinal bleeding within 6 months before inclusion

Outcomes

Primary Outcomes

Not specified

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