LUMINOS-101: Lerapolturev (PVSRIPO) and Pembrolizumab in Patients With Recurrent Glioblastoma (NCT04479241) | Clinical Trial Compass
CompletedPhase 2
LUMINOS-101: Lerapolturev (PVSRIPO) and Pembrolizumab in Patients With Recurrent Glioblastoma
United States25 participantsStarted 2020-10-21
Plain-language summary
This Phase 2 single arm trial in patients with rGBM will characterize the efficacy, safety, tolerability and initial efficacy of lerapolturev intratumoral infusion followed by intravenous pembrolizumab 14 to 28 days later, and every 3 weeks, thereafter.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ≥ 18 years of age.
. Recurrent supratentorial glioblastoma (GBM) confirmed via prior histology by the site's neuropathologist or designate.
. Enhancing lesion ≥1 cm shortest diameter to ≤ 5.5 cm longest diameter in all planes.
. Before catheter placement based on screening MRI and at the time of catheter placement via CT prior to infusion, neurosurgical investigator must confirm placement of infusion catheter within or through the progressive enhancing tumor is feasible and at a safe distance relative to eloquent brain function, with the tip of the catheter being placed:
. Within the enhancing portion or in the vicinity of enhancement of target lesion (ie, infiltrative disease).
. ≥ 0.5 cm from ventricles.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: 24 months
2
Frequency and Severity of Treatment-emergent Adverse Events
Timeframe: Up to 30 days after discontinuation of pembrolizumab
. Received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti- CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) ≤ 12 weeks prior to lerapolturev infusion (Note: does not apply for patients treated with pembrolizumab under this protocol who are eligible for lerapolturev retreatment). Note: patients who had previously permanently discontinued any anti-PD-1 or PD-L1 therapy due to severe or life-threatening immune-related adverse events are excluded.
. Excluded are:
. Neoplastic lesions in the brainstem, cerebellum, or spinal cord.
. Radiological evidence of active/growing multifocal disease: no size increase \> 0.5 cm in any direction of any other enhancing non-target lesions present at baseline confirmed via most recent, prior, consecutive MRIs at least 3 months apart.
. Tumors with ≥ 1cm of contrast-enhancing tumor component crossing the midline (crossing the corpus callosum).
. Extensive subependymal disease: multiple lesions or lesions covering \> 50% of subependymal space. Tumor touching subependymal space allowed.
. Extensive leptomeningeal disease: multiple lesions or lesions covering \> 50% of leptomeninges. Tumor touching leptomeninges allowed.
. Has received systemic immunosuppressive treatments other than systemic corticosteroids (eg, methotrexate, chloroquine, azathioprine) within six months of Lerapolturev infusion.