Trial Outcomes & Findings for LUMINOS-102: Lerapolturev With or Without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma (NCT NCT04577807)

NCT ID: NCT04577807

Last Updated: 2025-09-19

Results Overview

The number of patients achieving confirmed complete (CR) or partial response (PR), per RECIST 1.1 criteria

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 27 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2025-09-19

Participant Flow

Safety-run in: lerapolturev, up to 6x10^8 TCID50, administered on days 1, 10 and every 3 weeks thereafter. Total dose dependent on number and size of injectable lesions. Data are included in the Arm 1: lerapolturev Q3W group.

Participant milestones

Measure	Arm 1: Lerapolturev QW Lerapolturev, up to 1.6x10\^9 TCID50, administered via direct injection. Weekly for 7 weeks and every 3 weeks thereafter. Total dose dependent on number and size of injectable lesions.	Arm 1: Lerapolturev Q3W Lerapolturev, up to 1.6x10\^9 TCID50, administered every 3 weeks. Total dose dependent on number and size of injectable lesions.	Arm 2: Lerapolturev and Anti-PD-1 QW Lerapolturev, up to 1.6x10\^9 TCID50, administered via direct injection. Weekly for 7 weeks and every 3 or 4 weeks thereafter. Total dose dependent on number and size of injectable lesions. Anti-PD-1 therapy given as per the anti-PD-1 approved package insert. Anti-PD-1 therapy was physician's choice of pembrolizumab or nivolumab.	Arm 2: Lerapolturev and Anti-PD-1 Q3/Q4W Lerapolturev, up to 1.6x10\^9 TCID50, administered via direct injection every 3 or 4 weeks. Total dose dependent on number and size of injectable lesions. Anti-PD-1 therapy given as per the anti-PD-1 approved package insert. Anti-PD-1 therapy was physician's choice of pembrolizumab or nivolumab.
Overall Study STARTED	3	12	6	6
Overall Study Crossover	1	10	0	0
Overall Study COMPLETED	3	12	6	6
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

LUMINOS-102: Lerapolturev With or Without Immune Checkpoint Blockade in Advanced PD-1 Refractory Melanoma

Baseline characteristics by cohort

Measure	Arm 1: Lerapolturev QW n=3 Participants lerapolturev weekly for 7 weeks and every 3 weeks thereafter	Arm 1: Lerapolturev Q3W n=12 Participants lerapolturev at day 1, day 10 and every 3 weeks thereafter includes data from safety run-in	Arm 2: Lerapolturev + Anti-PD-1 QW n=6 Participants lerapolturev weekly for 7 weeks and every 3 or 4 weeks thereafter anti-PD-1 every 3 or 4 weeks per prescribing information starting at day 1	Arm 2: Lerapolturev + Anti-PD-1 Q3/4W n=6 Participants lerapolturev at day 1, day 10 and every 3 or 4 weeks thereafter anti-PD-1 every 3 or 4 weeks per prescribing information starting at day 10	Total n=27 Participants Total of all reporting groups
Age, Continuous	60 years n=5 Participants	59 years n=7 Participants	67 years n=5 Participants	65 years n=4 Participants	62 years n=21 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	12 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	8 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	15 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	11 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	25 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	12 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	26 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
ECOG Performance Status ECOG PS 0	3 patients n=5 Participants	7 patients n=7 Participants	2 patients n=5 Participants	3 patients n=4 Participants	15 patients n=21 Participants
ECOG Performance Status ECOG PS 1	0 patients n=5 Participants	5 patients n=7 Participants	4 patients n=5 Participants	3 patients n=4 Participants	12 patients n=21 Participants

PRIMARY outcome

Timeframe: 24 months

Population: Participants received at least one lerapolturev injection and had at least 1 post-baseline assessment.

The number of patients achieving confirmed complete (CR) or partial response (PR), per RECIST 1.1 criteria

Outcome measures

Measure	Arm 1: Lerapolturev QW n=3 Participants lerapolturev weekly for 7 weeks and every 3 weeks thereafter	Arm 1: Lerapolturev Q3W n=12 Participants lerapolturev at day 1, day 10 and every 3 weeks thereafter includes data from safety run-in	Arm 2: Lerapolturev + Anti-PD-1 QW n=5 Participants lerapolturev weekly for 7 weeks and every 3 or 4 weeks thereafter anti-PD-1 every 3 or 4 weeks per prescribing information starting day 1	Arm 2: Lerapolturev + Anti-PD-1 Q3/4W n=5 Participants lerapolturev at day 1, day 10 and every 3 or 4 weeks thereafter anti-PD-1 every 3 or 4 weeks per prescribing information starting day 10
Overall Response	0 Participants	1 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: 24 months

Population: The number of participants experiencing a treatment-emergent adverse event are reported here. Detailed data on frequency and severity is reported under Adverse Events.

The number of participants experiencing a treatment-emergent adverse event

Outcome measures

Measure	Arm 1: Lerapolturev QW n=3 Participants lerapolturev weekly for 7 weeks and every 3 weeks thereafter	Arm 1: Lerapolturev Q3W n=12 Participants lerapolturev at day 1, day 10 and every 3 weeks thereafter includes data from safety run-in	Arm 2: Lerapolturev + Anti-PD-1 QW n=6 Participants lerapolturev weekly for 7 weeks and every 3 or 4 weeks thereafter anti-PD-1 every 3 or 4 weeks per prescribing information starting day 1	Arm 2: Lerapolturev + Anti-PD-1 Q3/4W n=6 Participants lerapolturev at day 1, day 10 and every 3 or 4 weeks thereafter anti-PD-1 every 3 or 4 weeks per prescribing information starting day 10
Number of Participants Experiencing a Treatment-emergent Adverse Event	3 Participants	10 Participants	6 Participants	5 Participants

PRIMARY outcome

Timeframe: 24 months

The number of participants experiencing an AESI or irAE

Outcome measures

Measure	Arm 1: Lerapolturev QW n=3 Participants lerapolturev weekly for 7 weeks and every 3 weeks thereafter	Arm 1: Lerapolturev Q3W n=12 Participants lerapolturev at day 1, day 10 and every 3 weeks thereafter includes data from safety run-in	Arm 2: Lerapolturev + Anti-PD-1 QW n=6 Participants lerapolturev weekly for 7 weeks and every 3 or 4 weeks thereafter anti-PD-1 every 3 or 4 weeks per prescribing information starting day 1	Arm 2: Lerapolturev + Anti-PD-1 Q3/4W n=6 Participants lerapolturev at day 1, day 10 and every 3 or 4 weeks thereafter anti-PD-1 every 3 or 4 weeks per prescribing information starting day 10
Number of Participants Experiencing an Adverse Event of Special Interest (AESI) or Anti-PD-1 Immune Related Adverse Events (irAEs) Adverse Events of Special Interest	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Experiencing an Adverse Event of Special Interest (AESI) or Anti-PD-1 Immune Related Adverse Events (irAEs) Immune Related Adverse Events	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants Experiencing an Adverse Event of Special Interest (AESI) or Anti-PD-1 Immune Related Adverse Events (irAEs) No AESI or IrAE reported	3 Participants	12 Participants	3 Participants	6 Participants

PRIMARY outcome

Timeframe: 24 months

Number of participants discontinuing study treatment due to adverse event(s)

Outcome measures

Measure	Arm 1: Lerapolturev QW n=3 Participants lerapolturev weekly for 7 weeks and every 3 weeks thereafter	Arm 1: Lerapolturev Q3W n=12 Participants lerapolturev at day 1, day 10 and every 3 weeks thereafter includes data from safety run-in	Arm 2: Lerapolturev + Anti-PD-1 QW n=6 Participants lerapolturev weekly for 7 weeks and every 3 or 4 weeks thereafter anti-PD-1 every 3 or 4 weeks per prescribing information starting day 1	Arm 2: Lerapolturev + Anti-PD-1 Q3/4W n=6 Participants lerapolturev at day 1, day 10 and every 3 or 4 weeks thereafter anti-PD-1 every 3 or 4 weeks per prescribing information starting day 10
Number of Participants Discontinuing Study Treatment Due to Adverse Event(s)	0 Participants	0 Participants	2 Participants	1 Participants

PRIMARY outcome

Timeframe: 24 months

Population: Company ceased operations; samples were not analyzed. Measurement values for this outcome measure are not and will not be available.

Changes from baseline in the number of CD8+ tumor infiltrating lymphocytes (TILs)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 24 months

Population: Company ceased operations; samples were not analyzed. Measurement values for this outcome measure are not and will not be available.

Changes from baseline in PD-L1 expression

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Overall survival (OS): time from treatment group assignment until death from any cause.

Outcome measures

Measure	Arm 1: Lerapolturev QW n=3 Participants lerapolturev weekly for 7 weeks and every 3 weeks thereafter	Arm 1: Lerapolturev Q3W n=12 Participants lerapolturev at day 1, day 10 and every 3 weeks thereafter includes data from safety run-in	Arm 2: Lerapolturev + Anti-PD-1 QW n=5 Participants lerapolturev weekly for 7 weeks and every 3 or 4 weeks thereafter anti-PD-1 every 3 or 4 weeks per prescribing information starting day 1	Arm 2: Lerapolturev + Anti-PD-1 Q3/4W n=5 Participants lerapolturev at day 1, day 10 and every 3 or 4 weeks thereafter anti-PD-1 every 3 or 4 weeks per prescribing information starting day 10
Overall Survival	8.5 months Interval 1.5 to NA = not estimable, insufficient number of participants with events	4.3 months Interval 4.3 to NA = not estimable, insufficient number of participants with events	NA months Interval 9.9 to NA = not estimable, insufficient number of participants with events	10.5 months Interval 6.3 to NA = not estimable, insufficient number of participants with events

SECONDARY outcome

Timeframe: 24 months

Population: Participants had at least one dose of lerapolturev and at least one post-baseline assessment.

Duration of Response (DOR): time from confirmed objective response (CR or PR per RECIST 1.1) until unequivocal disease progression or death, whichever occurs first

Outcome measures

Measure	Arm 1: Lerapolturev QW n=3 Participants lerapolturev weekly for 7 weeks and every 3 weeks thereafter	Arm 1: Lerapolturev Q3W n=12 Participants lerapolturev at day 1, day 10 and every 3 weeks thereafter includes data from safety run-in	Arm 2: Lerapolturev + Anti-PD-1 QW n=5 Participants lerapolturev weekly for 7 weeks and every 3 or 4 weeks thereafter anti-PD-1 every 3 or 4 weeks per prescribing information starting day 1	Arm 2: Lerapolturev + Anti-PD-1 Q3/4W n=5 Participants lerapolturev at day 1, day 10 and every 3 or 4 weeks thereafter anti-PD-1 every 3 or 4 weeks per prescribing information starting day 10
Duration of Response	NA months Median and interquartile range are not estimable due to an insufficient number of events; therefore, NA is entered.	NA months Median and interquartile range are not estimable due to an insufficient number of events; therefore, NA is entered.	NA months Median and interquartile range are not estimable due to an insufficient number of events; therefore, NA is entered	NA months Median and interquartile range are not estimable due to an insufficient number of events; therefore, NA is entered

SECONDARY outcome

Timeframe: 24 months

The percentage of patients achieving confirmed CR, confirmed PR, or stable disease (SD) per RECIST1.1, as best response.

Outcome measures

Measure	Arm 1: Lerapolturev QW n=3 Participants lerapolturev weekly for 7 weeks and every 3 weeks thereafter	Arm 1: Lerapolturev Q3W n=12 Participants lerapolturev at day 1, day 10 and every 3 weeks thereafter includes data from safety run-in	Arm 2: Lerapolturev + Anti-PD-1 QW n=5 Participants lerapolturev weekly for 7 weeks and every 3 or 4 weeks thereafter anti-PD-1 every 3 or 4 weeks per prescribing information starting day 1	Arm 2: Lerapolturev + Anti-PD-1 Q3/4W n=5 Participants lerapolturev at day 1, day 10 and every 3 or 4 weeks thereafter anti-PD-1 every 3 or 4 weeks per prescribing information starting day 10
Disease Control Rate	67 percentage of patients Interval 1.0 to 91.0	42 percentage of patients Interval 28.0 to 85.0	60 percentage of patients Interval 5.0 to 85.0	20 percentage of patients Interval 20.0 to 99.0

SECONDARY outcome

Timeframe: 24 months

The number of patients achieving confirmed CR (any duration), confirmed PR (any duration) or SD (≥ 6 months) per RECIST 1.1 as best response.

Outcome measures

Measure	Arm 1: Lerapolturev QW n=3 Participants lerapolturev weekly for 7 weeks and every 3 weeks thereafter	Arm 1: Lerapolturev Q3W n=12 Participants lerapolturev at day 1, day 10 and every 3 weeks thereafter includes data from safety run-in	Arm 2: Lerapolturev + Anti-PD-1 QW n=5 Participants lerapolturev weekly for 7 weeks and every 3 or 4 weeks thereafter anti-PD-1 every 3 or 4 weeks per prescribing information starting day 1	Arm 2: Lerapolturev + Anti-PD-1 Q3/4W n=5 Participants lerapolturev at day 1, day 10 and every 3 or 4 weeks thereafter anti-PD-1 every 3 or 4 weeks per prescribing information starting day 10
DCR-6 Months	0 Participants	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 months

The percentage of participants with confirmed CR or PR (per RECIST 1.1) lasting at least 6 months

Outcome measures

Measure	Arm 1: Lerapolturev QW n=3 Participants lerapolturev weekly for 7 weeks and every 3 weeks thereafter	Arm 1: Lerapolturev Q3W n=12 Participants lerapolturev at day 1, day 10 and every 3 weeks thereafter includes data from safety run-in	Arm 2: Lerapolturev + Anti-PD-1 QW n=5 Participants lerapolturev weekly for 7 weeks and every 3 or 4 weeks thereafter anti-PD-1 every 3 or 4 weeks per prescribing information starting day 1	Arm 2: Lerapolturev + Anti-PD-1 Q3/4W n=5 Participants lerapolturev at day 1, day 10 and every 3 or 4 weeks thereafter anti-PD-1 every 3 or 4 weeks per prescribing information starting day 10
Durable Response Rate	0 percentage of patients Interval 0.0 to 71.0	0 percentage of patients Interval 0.0 to 26.0	0 percentage of patients Interval 0.0 to 52.0	0 percentage of patients Interval 0.0 to 52.0

SECONDARY outcome

Timeframe: 24 months

Progression-free survival (PFS): time (number of months) from treatment group assignment until date of documented radiologic disease progression per RECIST 1.1 or death due to any cause, whichever comes first

Outcome measures

Measure	Arm 1: Lerapolturev QW n=3 Participants lerapolturev weekly for 7 weeks and every 3 weeks thereafter	Arm 1: Lerapolturev Q3W n=12 Participants lerapolturev at day 1, day 10 and every 3 weeks thereafter includes data from safety run-in	Arm 2: Lerapolturev + Anti-PD-1 QW n=5 Participants lerapolturev weekly for 7 weeks and every 3 or 4 weeks thereafter anti-PD-1 every 3 or 4 weeks per prescribing information starting day 1	Arm 2: Lerapolturev + Anti-PD-1 Q3/4W n=5 Participants lerapolturev at day 1, day 10 and every 3 or 4 weeks thereafter anti-PD-1 every 3 or 4 weeks per prescribing information starting day 10
Progression-free Survival (PFS)	2.2 months Interval 1.3 to NA = not estimable, insufficient number of participants with events	1.9 months Interval 1.7 to 4.4	3.7 months Interval 1.4 to NA = not estimable, insufficient number of participants with events	1.6 months Interval 1.1 to NA = not estimable, insufficient number of participants with events

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: Outcome measure not evaluated

• Assessment and identification of genetic, cytologic, histologic and/or other markers in tumor biopsies and PBMC samples that may correlate with response.
• Assessment of changes over time in immune markers, including, but not limited to immune cell density, T cell receptor repertoire, and chemokine and/or cytokine profile in blood, samples, and/or tissue

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: Outcome measure not evaluated

ORR based on iRECIST criteria

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: Outcome measure not evaluated

DOR based on iRECIST criteria

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: Outcome measure not evaluated

DRR based on iRECIST criteria

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: Outcome measure not evaluated

DCR based on iRECIST criteria

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: Outcome measure not evaluated

DCR-6mo based on iRECIST criteria

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: Outcome measure not evaluated

ORR in the following subgroups:

• Acquired versus primary PD-1/L1 resistance as defined by Kluger, et al (2020)
• BRAF wild type and mutant
• LDH levels at baseline
• Time since last dose of anti-PD1/L1 therapy prior to randomization (≤ or >6 weeks)
• Crossover to combination arm from lerapolturev monotherapy

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: Outcome measure not evaluated

DOR in the following subgroups:

• Acquired versus primary PD-1/L1 resistance as defined by Kluger, et al (2020)
• BRAF wild type and mutant
• LDH levels at baseline
• Time since last dose of anti-PD1/L1 therapy prior to randomization (≤ or >6 weeks)
• Crossover to combination arm from lerapolturev monotherapy

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: Outcome measure not evaluated

DRR in the following subgroups:

• Acquired versus primary PD-1/L1 resistance as defined by Kluger, et al (2020)
• BRAF wild type and mutant
• LDH levels at baseline
• Time since last dose of anti-PD1/L1 therapy prior to randomization (≤ or >6 weeks)
• Crossover to combination arm from lerapolturev monotherapy

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: Outcome measure not evaluated

DCR in the following subgroups:

• Acquired versus primary PD-1/L1 resistance as defined by Kluger, et al (2020)
• BRAF wild type and mutant
• LDH levels at baseline
• Time since last dose of anti-PD1/L1 therapy prior to randomization (≤ or >6 weeks)
• Crossover to combination arm from lerapolturev monotherapy

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: Outcome measure not evaluated

DCR-6mo in the following subgroups:

• Acquired versus primary PD-1/L1 resistance as defined by Kluger, et al (2020)
• BRAF wild type and mutant
• LDH levels at baseline
• Time since last dose of anti-PD1/L1 therapy prior to randomization (≤ or >6 weeks)
• Crossover to combination arm from lerapolturev monotherapy

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: Outcome measure not evaluated

OS in the following subgroups:

• According to treatment arm and AJCC stage at baseline
• Primary versus acquired resistance as defined by Kluger et al
• BRAF wild type and mutant
• LDH levels at baseline
• Time since last dose of anti-PD1/L1 therapy prior to randomization (≤ or >6 weeks)
• Crossover to combination arm from lerapolturev monotherapy

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Population: Outcome measure not evaluated

PFS in the following subgroups:

• According to treatment arm and AJCC stage at baseline
• Primary versus acquired resistance as defined by Kluger et al
• BRAF wild type and mutant
• LDH levels at baseline
• Time since last dose of anti-PD1/L1 therapy prior to randomization (≤ or >6 weeks)
• Crossover to combination arm from lerapolturev monotherapy

Outcome measures

Outcome data not reported

Adverse Events

Arm 1: Lerapolturev QW

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Arm 1: Lerapolturev Q3W

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Arm 2: Lerapolturev + Anti-PD-1 QW

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Arm 2: Lerapolturev + Anti-PD-1 Q3/4W

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Crossover

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm 1: Lerapolturev QW n=3 participants at risk lerapolturev weekly for 7 weeks and every 3 weeks thereafter	Arm 1: Lerapolturev Q3W n=12 participants at risk lerapolturev at day 1, day 10 and every 3 weeks thereafter includes data from safety run-in	Arm 2: Lerapolturev + Anti-PD-1 QW n=6 participants at risk lerapolturev weekly for 7 weeks and every 3 or 4 weeks thereafter anti-PD-1 every 3 or 4 weeks per prescribing information starting day 1	Arm 2: Lerapolturev + Anti-PD-1 Q3/4W n=6 participants at risk lerapolturev at day 1, day 10 and every 3 or 4 weeks thereafter anti-PD-1 every 3 or 4 weeks per prescribing information starting day 10	Crossover n=11 participants at risk Initially received lerapolturev (up to 1.6x10\^9 TCID50) administered via direct injection. Crossed over to Arm 2: lerapolturev and anti-PD-1. Anti-PD-1 therapy given as per the anti-PD-1 approved package insert.
Infections and infestations Pneumonia	0.00% 0/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	9.1% 1/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Infections and infestations Sepsis	0.00% 0/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	9.1% 1/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Infections and infestations Urosepsis	0.00% 0/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	16.7% 1/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Blood and lymphatic system disorders Anemia	0.00% 0/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	16.7% 1/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
General disorders Asthenia	0.00% 0/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	16.7% 1/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Metabolism and nutrition disorders Dehydration	33.3% 1/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Metabolism and nutrition disorders Hyponatremia	33.3% 1/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	16.7% 1/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Nervous system disorders Cerebrovascular accident	0.00% 0/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	9.1% 1/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Product Issues Device occlusion	0.00% 0/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	9.1% 1/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Psychiatric disorders Mental status changes	33.3% 1/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	16.7% 1/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	16.7% 1/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5

Other adverse events

Measure	Arm 1: Lerapolturev QW n=3 participants at risk lerapolturev weekly for 7 weeks and every 3 weeks thereafter	Arm 1: Lerapolturev Q3W n=12 participants at risk lerapolturev at day 1, day 10 and every 3 weeks thereafter includes data from safety run-in	Arm 2: Lerapolturev + Anti-PD-1 QW n=6 participants at risk lerapolturev weekly for 7 weeks and every 3 or 4 weeks thereafter anti-PD-1 every 3 or 4 weeks per prescribing information starting day 1	Arm 2: Lerapolturev + Anti-PD-1 Q3/4W n=6 participants at risk lerapolturev at day 1, day 10 and every 3 or 4 weeks thereafter anti-PD-1 every 3 or 4 weeks per prescribing information starting day 10	Crossover n=11 participants at risk Initially received lerapolturev (up to 1.6x10\^9 TCID50) administered via direct injection. Crossed over to Arm 2: lerapolturev and anti-PD-1. Anti-PD-1 therapy given as per the anti-PD-1 approved package insert.
General disorders Fatigue	33.3% 1/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	16.7% 2/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	50.0% 3/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	54.5% 6/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
General disorders Pain	33.3% 1/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	16.7% 1/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	16.7% 1/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
General disorders Asthenia	0.00% 0/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	33.3% 2/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
General disorders Pyrexia	0.00% 0/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	8.3% 1/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	16.7% 1/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	9.1% 1/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Gastrointestinal disorders Vomiting	33.3% 1/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	25.0% 3/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	33.3% 2/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	18.2% 2/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Gastrointestinal disorders Constipation	0.00% 0/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	8.3% 1/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	33.3% 2/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Gastrointestinal disorders Nausea	0.00% 0/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	16.7% 2/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	16.7% 1/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	18.2% 2/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Metabolism and nutrition disorders Hyponatremia	33.3% 1/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	16.7% 2/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	16.7% 1/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	9.1% 1/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	8.3% 1/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	16.7% 1/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	9.1% 1/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Metabolism and nutrition disorders Hypoalbunemia	0.00% 0/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	8.3% 1/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	16.7% 1/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Metabolism and nutrition disorders Hypokalemia	0.00% 0/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	16.7% 2/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	18.2% 2/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Investigations Blood lactate dehydrogenase increase	0.00% 0/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	16.7% 2/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	16.7% 1/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	18.2% 2/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Investigations Amylase increased	33.3% 1/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	8.3% 1/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	9.1% 1/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Investigations Lipase increased	0.00% 0/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	8.3% 1/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	16.7% 1/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	9.1% 1/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	8.3% 1/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	66.7% 4/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	9.1% 1/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Musculoskeletal and connective tissue disorders Back pain	33.3% 1/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	8.3% 1/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	16.7% 1/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	18.2% 2/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	16.7% 2/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	18.2% 2/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Vascular disorders Hypertension	33.3% 1/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	8.3% 1/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	33.3% 2/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	16.7% 1/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	9.1% 1/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor haemorrhage	0.00% 0/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	8.3% 1/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	16.7% 1/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	16.7% 2/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	9.1% 1/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Nervous system disorders Headache	33.3% 1/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	8.3% 1/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	9.1% 1/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5
Endocrine disorders Hypothyroidism	0.00% 0/3 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/12 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	16.7% 1/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	16.7% 1/6 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5	0.00% 0/11 • Arm 1: from treatment start until last dose of study treatment, up to 2 years, or until crossover to Arm 2 Crossover participants: from time of crossover from Arm 1 to Arm 2 until 30 days after last dose of study treatment, up to 2 years Arm 2: from treatment start until last dose of study treatment, up to 2 years Adverse events were graded using NCI Common Terminology Criteria for Adverse Events v5

Additional Information

Head of Operations

Istari Oncology

Phone: 919-245-7662

Email: info@istarioncology.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60