ACTRN12623001126606
Recruiting
Phase 1
Phase I/II clinical trial evaluating the safety and efficacy of allogeneic cytomegalovirus-specific T cells in combination with pembrolizumab for recurrent and newly diagnosed glioblastoma multiforme
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Glioblastoma multiforme/astrocytoma grade 4
- Sponsor
- QIMR Berghofer Medical Research Institute
- Enrollment
- 58
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Participants who are at least 18 years of age on the day of signing informed consent with
- •histologically confirmed diagnosis of GBM or astrocytoma Grade 4\.
- •a. For participants with recurrent GBM or astrocytoma grade 4, histological confirmation of
- •primary diagnosis is available
- •i. First occurrence of disease progression with radiological confirmation greater than or equal to 12 weeks from completion of radiation therapy.
- •ii. Where surgical resection of recurrent disease occurred, histological confirmation of GBM or
- •astrocytoma Grade 4 is required.
- •b. For participants with newly diagnosed GBM or astrocytoma Grade 4, histological confirmation of diagnosis is required
- •i. Participant, in consultation with their treating clinicians, is willing to delay the
- •commencement of standard of care adjuvant temozolomide until the completion of CMV\-specific T cell therapy infusions.
Exclusion Criteria
- •1\. A WOCBP who has a positive urine pregnancy test within 72 hours prior of study intervention. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •2\. Has received prior therapy with an anti\-PD\-1, anti\-PD\-L1, or anti\-PD\-L2 agent or with an agent directed to another stimulatory or co\-inhibitory T\-cell receptor (e.g., CTLA\-4, OX\-40, CD137\).
- •3\. Has received prior systemic anti\-cancer therapy or investigational agents within 4 weeks prior to study intervention, with the exception of temozolomide, which is permitted during the trial.
- •4\. Participants enrolled with recurrent disease must have recovered from all radiation\-related toxicities not require corticosteroids (other than dexamethasone) and not have had radiation pneumonitis. A 1\-week washout is permitted for palliative radiation (less than or equal to 2 weeks of radiotherapy) to non\-CNS disease.
- •Note: Participants receiving dexamethasone must be clinically stable and receiving a stable or weaning dose of less than or equal to 2mg/day 1–2 weeks prior to the commencement of pembrolizumab
- •5\. Has received a live vaccine or live\-attenuated vaccine within 30 days prior to the first dose of study intervention. Administration of killed vaccines is allowed.
- •6\. Has received in an investigational agent, or has used an investigational device within 4 weeks prior to the first dose of study intervention.
- •7\. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- •8\. Known additional malignancy that is progressing or has required active treatment within the past 5 years.
- •Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, prostate cancer treated with radical prostatectomy, or carcinoma in situ, excluding carcinoma in situ of the bladder, who have undergone potentially curative therapy are not excluded.
Outcomes
Primary Outcomes
Not specified
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