Trial Outcomes & Findings for LUMINOS-101: Lerapolturev (PVSRIPO) and Pembrolizumab in Patients With Recurrent Glioblastoma (NCT NCT04479241)
NCT ID: NCT04479241
Last Updated: 2025-06-05
Results Overview
Objective response rate (comprised of patients meeting an objective radiographic response or ORR): Patients achieving a complete response (CR) or partial response (PR).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
24 months
Results posted on
2025-06-05
Participant Flow
Participant milestones
| Measure |
Lerapolturev + Pembrolizumab
Lerapolturev (5x10\^7 TCID50) delivered intratumorally via convection enhanced delivery (CED).
Pembrolizumab (200 mg IV) given intravenously every 3 weeks.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LUMINOS-101: Lerapolturev (PVSRIPO) and Pembrolizumab in Patients With Recurrent Glioblastoma
Baseline characteristics by cohort
| Measure |
Lerapolturev + Pembrolizumab
n=25 Participants
Lerapolturev delivered once intratumorally via convection enhanced delivery. Pembrolizumab given intravenously every 3 weeks.
|
|---|---|
|
Age, Continuous
|
55 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
|
Karnofsky Performance Status
80
|
8 Participants
n=5 Participants
|
|
Karnofsky Performance Status
90
|
13 Participants
n=5 Participants
|
|
Karnofsky Performance Status
100
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: No CR or PR were documented; therefore, DOR and DRR cannot be assessed.
Objective response rate (comprised of patients meeting an objective radiographic response or ORR): Patients achieving a complete response (CR) or partial response (PR).
Outcome measures
| Measure |
Lerapolturev + Pembrolizumab
n=25 Participants
Lerapolturev delivered once intratumorally via convection enhanced delivery. Pembrolizumab given intravenously every 3 weeks.
|
|---|---|
|
Objective Response Rate (ORR)
|
0 participants
|
PRIMARY outcome
Timeframe: Up to 30 days after discontinuation of pembrolizumabPopulation: patients receiving PVSRIPO and at least one dose of pembrolizumab
Count of participants experiencing a treatment-emergent adverse event is reported here. Detailed frequency and severity data are reported in the Adverse Event table.
Outcome measures
| Measure |
Lerapolturev + Pembrolizumab
n=25 Participants
Lerapolturev delivered once intratumorally via convection enhanced delivery. Pembrolizumab given intravenously every 3 weeks.
|
|---|---|
|
Frequency and Severity of Treatment-emergent Adverse Events
|
25 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: No CR or PR were documented; therefore, DOR cannot be assessed.
DOR: Time from first ORR observed (once confirmed) until PD first observed (once confirmed) or death; whichever comes first.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 24 monthsPopulation: No CR or PR were documented; therefore, DRR cannot be assessed.
DRR: An ORR that persists for ≥ 6 months.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsProportion of patients achieving stable disease (SD), CR or PR via protocol-specified response criteria
Outcome measures
| Measure |
Lerapolturev + Pembrolizumab
n=25 Participants
Lerapolturev delivered once intratumorally via convection enhanced delivery. Pembrolizumab given intravenously every 3 weeks.
|
|---|---|
|
Disease Control Rate (DCR)
|
4 percentage of participants
Interval 0.0 to 14.0
|
SECONDARY outcome
Timeframe: 24 monthsOverall survival (months) post-lerapolturev infusion estimated by Kaplan-Meier methods.
Outcome measures
| Measure |
Lerapolturev + Pembrolizumab
n=25 Participants
Lerapolturev delivered once intratumorally via convection enhanced delivery. Pembrolizumab given intravenously every 3 weeks.
|
|---|---|
|
Survival Assessed by Kaplan-Meier Methods
|
10.2 months
Interval 8.9 to 15.9
|
Adverse Events
Lerapolturev + Pembrolizumab
Serious events: 8 serious events
Other events: 25 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
Lerapolturev + Pembrolizumab
n=25 participants at risk
Lerapolturev delivered once intratumorally via convection enhanced delivery. Pembrolizumab given intravenously every 3 weeks.
|
|---|---|
|
Nervous system disorders
hemiparesis
|
8.0%
2/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Nervous system disorders
brain oedema
|
4.0%
1/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Nervous system disorders
haemorrhage intracranial
|
4.0%
1/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Nervous system disorders
headache
|
4.0%
1/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Nervous system disorders
seizure
|
4.0%
1/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
peritumoural oedema
|
8.0%
2/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Infections and infestations
pneumonia
|
4.0%
1/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
4.0%
1/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Surgical and medical procedures
craniotomy
|
4.0%
1/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
Other adverse events
| Measure |
Lerapolturev + Pembrolizumab
n=25 participants at risk
Lerapolturev delivered once intratumorally via convection enhanced delivery. Pembrolizumab given intravenously every 3 weeks.
|
|---|---|
|
Nervous system disorders
headache
|
80.0%
20/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Nervous system disorders
hemiparesis
|
52.0%
13/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Nervous system disorders
seizure
|
36.0%
9/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Nervous system disorders
aphasia
|
16.0%
4/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Nervous system disorders
cognitive disorder
|
16.0%
4/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Nervous system disorders
dizziness
|
16.0%
4/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Nervous system disorders
paraesthesia
|
16.0%
4/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Nervous system disorders
brain oedema
|
12.0%
3/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Nervous system disorders
hemianopia homonymous
|
12.0%
3/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Nervous system disorders
amnesia
|
8.0%
2/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Nervous system disorders
dysarthria
|
8.0%
2/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Nervous system disorders
facial paralysis
|
8.0%
2/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Nervous system disorders
visual field defect
|
8.0%
2/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Gastrointestinal disorders
nausea
|
44.0%
11/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Gastrointestinal disorders
vomiting
|
28.0%
7/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Gastrointestinal disorders
constipation
|
16.0%
4/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Gastrointestinal disorders
diarrhoea
|
16.0%
4/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Gastrointestinal disorders
gastrooesophageal reflux disease
|
16.0%
4/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Gastrointestinal disorders
dysphagia
|
8.0%
2/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
General disorders
fatigue
|
56.0%
14/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
General disorders
gait disturbance
|
16.0%
4/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
General disorders
pyrexia
|
8.0%
2/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Investigations
lymphocyte count decreased
|
12.0%
3/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Investigations
alanine aminotransferase increased
|
8.0%
2/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Psychiatric disorders
insomnia
|
16.0%
4/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Psychiatric disorders
agitation
|
8.0%
2/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Psychiatric disorders
confusional state
|
8.0%
2/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Metabolism and nutrition disorders
hyperglycaemia
|
12.0%
3/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Metabolism and nutrition disorders
hyponatraemia
|
12.0%
3/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Metabolism and nutrition disorders
decreased appetite
|
8.0%
2/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Metabolism and nutrition disorders
hypoalbuminaemia
|
8.0%
2/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Metabolism and nutrition disorders
hypocalcaemia
|
8.0%
2/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
12.0%
3/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Musculoskeletal and connective tissue disorders
back pain
|
12.0%
3/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
12.0%
3/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Musculoskeletal and connective tissue disorders
flank pain
|
8.0%
2/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
peritumoural oedema
|
28.0%
7/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
12.0%
3/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
8.0%
2/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Eye disorders
photopsia
|
8.0%
2/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Renal and urinary disorders
urinary tract infection
|
8.0%
2/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Skin and subcutaneous tissue disorders
rash maculo-papular
|
12.0%
3/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Skin and subcutaneous tissue disorders
dermatitis acneiform
|
8.0%
2/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Vascular disorders
hypertension
|
16.0%
4/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
|
Blood and lymphatic system disorders
anaemia
|
12.0%
3/25 • Adverse events were collected for 30 days after the last infusion of pembrolizumab, up to 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot extend the embargo. The sponsor may request removal of confidential information that does not affect the complete and accurate presentation or interpretation of results.
- Publication restrictions are in place
Restriction type: OTHER