Trial Outcomes & Findings for Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07). (NCT NCT04068181)

NCT ID: NCT04068181

Last Updated: 2025-01-07

Results Overview

ORR was defined as the incidence of a best overall response (BOR) of complete response (CR) or partial response (PR) per modified RECIST v1.1: * CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm. All lymph nodes must have been non-pathological in size (\< 10mm short axis). * PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. * Non-CR/Non-progressive disease (PD): Persistence of 1 or more non-target lesion(s).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

72 participants

Primary outcome timeframe

Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

Results posted on

2025-01-07

Participant Flow

72 participants were enrolled at 28 centers in Australia, Canada, France, Germany, Greece, Italy, the Netherlands, Poland, Spain and the United States from 22 January 2020 to 26 February 2024.

Participants must have received prior anti-programmed cell death protein (anti-PD-1) therapy for at least 2 to 3 consecutive cycles within an 8-week period and have disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. The anti-PD-1 therapy must have been the immediate prior line of therapy before enrollment, and participants with disease progression on more than 1 line of anti-PD-1 therapy were not eligible.

Participant milestones

Participant milestones
Measure
Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 plaque-forming units (PFU)/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an intravenous (IV) infusion every 3 weeks for up to 35 cycles.
Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months
Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of \< 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months
Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Overall Study
STARTED
27
15
15
15
Overall Study
Received Talimogene Laherparepvec
26
15
15
15
Overall Study
Received Pembrolizumab
26
15
15
15
Overall Study
COMPLETED
6
3
11
8
Overall Study
NOT COMPLETED
21
12
4
7

Reasons for withdrawal

Reasons for withdrawal
Measure
Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 plaque-forming units (PFU)/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an intravenous (IV) infusion every 3 weeks for up to 35 cycles.
Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months
Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of \< 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months
Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Overall Study
Death
17
12
4
7
Overall Study
Lost to Follow-up
1
0
0
0
Overall Study
Withdrawal of consent from study
3
0
0
0

Baseline Characteristics

Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance
n=26 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 plaque-forming units (PFU)/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an intravenous (IV) infusion every 3 weeks for up to 35 cycles.
Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance
n=15 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months
n=15 Participants
Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of \< 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months
n=15 Participants
Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Total
n=71 Participants
Total of all reporting groups
Age, Continuous
63.2 Years
STANDARD_DEVIATION 14.6 • n=5 Participants
65.5 Years
STANDARD_DEVIATION 13.2 • n=7 Participants
59.4 Years
STANDARD_DEVIATION 13.0 • n=5 Participants
63.5 Years
STANDARD_DEVIATION 10.3 • n=4 Participants
62.9 Years
STANDARD_DEVIATION 13.1 • n=21 Participants
Sex: Female, Male
Female
8 Participants
n=5 Participants
8 Participants
n=7 Participants
5 Participants
n=5 Participants
2 Participants
n=4 Participants
23 Participants
n=21 Participants
Sex: Female, Male
Male
18 Participants
n=5 Participants
7 Participants
n=7 Participants
10 Participants
n=5 Participants
13 Participants
n=4 Participants
48 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
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
Ethnicity (NIH/OMB)
Not Hispanic or Latino
25 Participants
n=5 Participants
14 Participants
n=7 Participants
14 Participants
n=5 Participants
15 Participants
n=4 Participants
68 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
3 Participants
n=21 Participants
Race
American Indian or Alaska Native
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
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
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
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
White
25 Participants
n=5 Participants
14 Participants
n=7 Participants
14 Participants
n=5 Participants
15 Participants
n=4 Participants
68 Participants
n=21 Participants
Race
Other
1 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
3 Participants
n=21 Participants

PRIMARY outcome

Timeframe: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

Population: Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination.

ORR was defined as the incidence of a best overall response (BOR) of complete response (CR) or partial response (PR) per modified RECIST v1.1: * CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm. All lymph nodes must have been non-pathological in size (\< 10mm short axis). * PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. * Non-CR/Non-progressive disease (PD): Persistence of 1 or more non-target lesion(s).

Outcome measures

Outcome measures
Measure
Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance
n=26 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 plaque-forming units (PFU)/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an intravenous (IV) infusion every 3 weeks for up to 35 cycles.
Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance
n=15 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months
n=15 Participants
Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of \< 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months
n=15 Participants
Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Objective Response Rate (ORR) Per Modified RECIST v1.1
3.8 Percentage of Participants
Interval 0.1 to 19.64
6.7 Percentage of Participants
Interval 0.17 to 31.95
40.0 Percentage of Participants
Interval 16.34 to 67.71
46.7 Percentage of Participants
Interval 21.27 to 73.41

SECONDARY outcome

Timeframe: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

Population: Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination.

CRR was defined as the incidence of a BOR of CR per modified RECIST v1.1: * CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm. All lymph nodes must have been non-pathological in size (\< 10mm short axis). Confirmation of CR was not required per modified RECIST v1.1.

Outcome measures

Outcome measures
Measure
Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance
n=26 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 plaque-forming units (PFU)/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an intravenous (IV) infusion every 3 weeks for up to 35 cycles.
Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance
n=15 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months
n=15 Participants
Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of \< 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months
n=15 Participants
Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Complete Response Rate (CRR) Per Modified RECIST v1.1
0 Percentage of Participants
No participants achieved a CR so the 95% confidence interval was not estimable.
0 Percentage of Participants
No participants achieved a CR so the 95% confidence interval was not estimable.
20.0 Percentage of Participants
Interval 4.33 to 48.09
20.0 Percentage of Participants
Interval 4.33 to 48.09

SECONDARY outcome

Timeframe: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

Population: Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination.

iCRR was defined as the incidence of a best overall response (iBOR) of a complete response (iCR) per modified irRC-RECIST: * iCR: Disappearance of all lesions (whether measurable or not and whether baseline or new). Any pathological lymph nodes (whether target or nontarget) must have had a reduction in short axis to \< 10 mm. Confirmation of iCR was required per modified irRC-RECIST.

Outcome measures

Outcome measures
Measure
Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance
n=26 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 plaque-forming units (PFU)/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an intravenous (IV) infusion every 3 weeks for up to 35 cycles.
Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance
n=15 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months
n=15 Participants
Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of \< 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months
n=15 Participants
Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Complete Response Rate (iCRR) Per Modified Immune-related Response Criteria (irRC) RECIST v1.1
0 Percentage of Participants
No participants achieved an iCR so the 95% confidence interval is not evaluable.
0 Percentage of Participants
No participants achieved an iCR so the 95% confidence interval is not evaluable.
26.7 Percentage of Participants
Interval 7.79 to 55.1
20.0 Percentage of Participants
Interval 4.33 to 48.09

SECONDARY outcome

Timeframe: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

Population: Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination.

BOR was the best overall visit response up to \& including the first overall visit response of PD: * CR: Disappearance of all target \& non-target lesions. Any pathological lymph nodes must have had a reduction in short axis to \<10 mm. All lymph nodes must have been non-pathological in size. * PR: ≥30% decrease in the sum of diameters of target lesions. * Stable disease (SD): Neither sufficient shrinkage to qualify for PR/CR nor sufficient increase to qualify for PD. * PD: ≥20% increase in the sum of diameters of target lesions and an increase of ≥5mm. Progression of existing non-target lesions. * Unable to evaluate (UE): Any lesion present at baseline which was not assessed or unable to be evaluated leading to an inability to determine the status of that particular tumor. * Non-CR/Non-PD: Persistence of 1+ non-target lesion(s). Non-CR/non-PD was relevant to participants who did not have measurable disease at baseline. Confirmation of CR, PR \& PD were not required per modified RECIST 1.1.

Outcome measures

Outcome measures
Measure
Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance
n=26 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 plaque-forming units (PFU)/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an intravenous (IV) infusion every 3 weeks for up to 35 cycles.
Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance
n=15 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months
n=15 Participants
Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of \< 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months
n=15 Participants
Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
BOR Per Modified RECIST v1.1
CR
0 Participants
0 Participants
3 Participants
3 Participants
BOR Per Modified RECIST v1.1
PR
1 Participants
1 Participants
3 Participants
4 Participants
BOR Per Modified RECIST v1.1
SD
7 Participants
4 Participants
0 Participants
6 Participants
BOR Per Modified RECIST v1.1
PD
11 Participants
5 Participants
9 Participants
1 Participants
BOR Per Modified RECIST v1.1
UE
0 Participants
1 Participants
0 Participants
0 Participants
BOR Per Modified RECIST v1.1
Non-CR/Non-PD
1 Participants
0 Participants
0 Participants
0 Participants
BOR Per Modified RECIST v1.1
Not Done
6 Participants
4 Participants
0 Participants
1 Participants

SECONDARY outcome

Timeframe: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

Population: Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination.

iBOR was defined as the best overall visit response up to and including the first overall visit response of progressive disease (iPD) per modified irRC-RECIST: * iCR: Disappearance of all lesions (whether measurable or not and whether baseline or new). Any pathological lymph nodes (whether target or nontarget) must have a reduction in short axis to \< 10 mm. * Partial response (iPR): Decrease in tumor burden ≥ 30% relative to baseline. * Stable disease (iSD): Neither sufficient shrinkage to qualify for iPR or iCR nor sufficient increase to qualify for iPD. * iPD: Increase in tumor burden ≥ 20% and at least 5 mm absolute increase. * Unable to evaluate (iUE): Any lesion present at baseline or a new measurable lesion which was not assessed or was unable to be evaluated leading to an inability to determine the status of that particular tumor for that time point. Confirmation of iCR, iPR and iPD was required per modified irRC-RECIST.

Outcome measures

Outcome measures
Measure
Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance
n=26 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 plaque-forming units (PFU)/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an intravenous (IV) infusion every 3 weeks for up to 35 cycles.
Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance
n=15 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months
n=15 Participants
Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of \< 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months
n=15 Participants
Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Best Overall Response (iBOR) Per Modified irRC-RECIST
iCR
0 Participants
0 Participants
4 Participants
3 Participants
Best Overall Response (iBOR) Per Modified irRC-RECIST
iPR
3 Participants
1 Participants
7 Participants
4 Participants
Best Overall Response (iBOR) Per Modified irRC-RECIST
iSD
10 Participants
5 Participants
0 Participants
6 Participants
Best Overall Response (iBOR) Per Modified irRC-RECIST
iPD
5 Participants
4 Participants
1 Participants
0 Participants
Best Overall Response (iBOR) Per Modified irRC-RECIST
iUE
2 Participants
1 Participants
2 Participants
1 Participants
Best Overall Response (iBOR) Per Modified irRC-RECIST
Not Done
6 Participants
4 Participants
1 Participants
1 Participants

SECONDARY outcome

Timeframe: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

Population: Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination.

DRR was defined as the percentage of participants with a CR or PR per modified RECIST v1.1 with a duration of response (DOR) ≥ 6 months. One month was calculated based on 365.25 days per year. * CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm. All lymph nodes must have been non-pathological in size (\< 10mm short axis). * PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Confirmation of CR and PR were not required per modified RECIST v1.1.

Outcome measures

Outcome measures
Measure
Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance
n=26 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 plaque-forming units (PFU)/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an intravenous (IV) infusion every 3 weeks for up to 35 cycles.
Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance
n=15 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months
n=15 Participants
Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of \< 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months
n=15 Participants
Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Durable Response Rate (DRR) Per Modified RECIST v1.1
3.8 Percentage of Participants
Interval 0.1 to 19.64
6.7 Percentage of Participants
Interval 0.17 to 31.95
40.0 Percentage of Participants
Interval 16.34 to 67.71
26.7 Percentage of Participants
Interval 7.79 to 55.1

SECONDARY outcome

Timeframe: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

Population: Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination.

iDRR was defined as the percentage of participants with an iCR or iPR per modified irRC-RECIST with a duration of response (iDOR) ≥ 6 months. One month was calculated based on 365.25 days per year. * iCR: Disappearance of all lesions (whether measurable or not and whether baseline or new). Any pathological lymph nodes (whether target or nontarget) must have a reduction in short axis to \< 10 mm. * iPR: Decrease in tumor burden ≥ 30% relative to baseline. Confirmation of iCR and iPR were required per modified irRC-RECIST.

Outcome measures

Outcome measures
Measure
Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance
n=26 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 plaque-forming units (PFU)/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an intravenous (IV) infusion every 3 weeks for up to 35 cycles.
Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance
n=15 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months
n=15 Participants
Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of \< 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months
n=15 Participants
Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Durable Response Rate (iDRR) Per Modified irRC-RECIST
11.5 Percentage of Participants
Interval 2.45 to 30.15
6.7 Percentage of Participants
Interval 0.17 to 31.95
73.3 Percentage of Participants
Interval 44.9 to 92.21
40.0 Percentage of Participants
Interval 16.34 to 67.71

SECONDARY outcome

Timeframe: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

Population: Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination. Only participants who had an initial response of CR or PR were included.

DOR was defined as the time from the date of an initial response of CR or PR to the earlier of PD/death. Participants who had not ended their response at the time of analysis were censored at their last evaluable tumor assessment date before start of first subsequent anticancer therapy. One month was calculated based on 365.25 days per year. * CR:Disappearance of all target \& non-target lesions. All lymph nodes must have a reduction in short axis to \<10 mm. Any pathological lymph nodes must have had a reduction in short axis to \<10 mm. All lymph nodes must have been non-pathological in size (\<10mm short axis). * PR:At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. * PD:At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions. Confirmation of CR, PR and PD were not required per modified RECIST v1.1.

Outcome measures

Outcome measures
Measure
Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance
n=1 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 plaque-forming units (PFU)/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an intravenous (IV) infusion every 3 weeks for up to 35 cycles.
Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance
n=1 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months
n=6 Participants
Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of \< 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months
n=7 Participants
Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
DOR Per Modified RECIST v1.1
22.768 Months
Dispersion data could not be calculated as only 1 participant experienced a response.
7.655 Months
Dispersion data could not be calculated as only 1 participant experienced a response.
NA Months
Interval 19.351 to
Median DOR and upper limit of 95% confidence interval was not reached due to the low number of events (PD or death).
13.700 Months
Interval 5.52 to
Upper limit of 95% confidence interval was not reached due to the low number of events (PD or death).

SECONDARY outcome

Timeframe: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

Population: Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination. Only participants who had an initial response of iCR or iPR were included.

iDOR was defined as the time from the date of an initial response that is subsequently confirmed to the earlier of iPD per modified irRC-RECIST. Participants who had not ended their response at the time of analysis were censored at their last evaluable tumor assessment date before start of first subsequent anticancer therapy. One month was calculated based on 365.25 days per year. * iCR: Disappearance of all target and non-target lesions. All lymph nodes must have a reduction in short axis to \< 10 mm. * iPR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. * iPD: At least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. Unequivocal progression of existing non-target lesions.

Outcome measures

Outcome measures
Measure
Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance
n=3 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 plaque-forming units (PFU)/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an intravenous (IV) infusion every 3 weeks for up to 35 cycles.
Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance
n=1 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months
n=11 Participants
Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of \< 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months
n=7 Participants
Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
iDOR Per Modified irRC-RECIST
NA Months
Interval 22.768 to
Median iDOR and upper limit of 95% confidence interval was not reached due to the low number of events (PD or death).
7.655 Months
Dispersion data could not be calculated as only 1 participant experienced a response.
NA Months
No participants experienced a response that had ended so no data were estimable
NA Months
Interval 11.302 to
Median iDOR and upper limit of 95% confidence interval was not reached due to the low number of events (PD or death).

SECONDARY outcome

Timeframe: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

Population: Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination.

DCR per modified RECIST v1.1 was defined as the incidence of a BOR of CR, PR or SD. * CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm. All lymph nodes must have been non-pathological in size (\< 10mm short axis * PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. * SD: Neither sufficient shrinkage to qualify for PR or CR nor sufficient increase to qualify for PD. Confirmation of CR and PR were not required per modified RECIST v1.1.

Outcome measures

Outcome measures
Measure
Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance
n=26 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 plaque-forming units (PFU)/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an intravenous (IV) infusion every 3 weeks for up to 35 cycles.
Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance
n=15 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months
n=15 Participants
Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of \< 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months
n=15 Participants
Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Disease Control Rate (DCR) Per Modified RECIST v1.1
30.8 Percentage of Participants
Interval 14.33 to 51.79
33.3 Percentage of Participants
Interval 11.82 to 61.62
40.0 Percentage of Participants
Interval 16.34 to 67.71
86.7 Percentage of Participants
Interval 59.54 to 98.34

SECONDARY outcome

Timeframe: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

Population: Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination.

iDCR per modified irRC-RECIST was defined as the incidence of an iBOR of iCR, iPR or iSD. * iCR: Disappearance of all target and non-target lesions. All lymph nodes must have a reduction in short axis to \< 10 mm. * iPR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. * iSD: Neither sufficient shrinkage to qualify for iPR or iCR nor sufficient increase to qualify for iPD. Confirmation of iCR and iPR were required per modified irRC-RECIST.

Outcome measures

Outcome measures
Measure
Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance
n=26 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 plaque-forming units (PFU)/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an intravenous (IV) infusion every 3 weeks for up to 35 cycles.
Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance
n=15 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months
n=15 Participants
Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of \< 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months
n=15 Participants
Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Disease Control Rate (iDCR) Per Modified irRC-RECIST
50.0 Percentage of Participants
Interval 29.93 to 70.07
40.0 Percentage of Participants
Interval 16.34 to 67.71
73.3 Percentage of Participants
Interval 44.9 to 92.21
86.7 Percentage of Participants
Interval 59.54 to 98.34

SECONDARY outcome

Timeframe: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

Population: Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination.

iORR was defined as the incidence of an iBOR of iCR or iPR per modified irRC-RECIST * iCR: Disappearance of all lesions (whether measurable or not and whether baseline or new). Any pathological lymph nodes (whether target or nontarget) must have a reduction in short axis to \< 10 mm. * iPR: Decrease in tumor burden ≥ 30% relative to baseline. Confirmation of iCR and iPR were required per modified irRC-RECIST.

Outcome measures

Outcome measures
Measure
Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance
n=26 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 plaque-forming units (PFU)/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an intravenous (IV) infusion every 3 weeks for up to 35 cycles.
Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance
n=15 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months
n=15 Participants
Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of \< 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months
n=15 Participants
Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Objective Response Rate (iORR) Per Modified irRC-RECIST
11.5 Percentage of Participants
Interval 2.45 to 30.15
6.7 Percentage of Participants
Interval 0.17 to 31.95
73.3 Percentage of Participants
Interval 44.9 to 92.21
46.7 Percentage of Participants
Interval 21.27 to 73.41

SECONDARY outcome

Timeframe: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

Population: Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination.

PFS per modified RECIST 1.1 was defined as the interval from first dose to the earlier event of PD or death from any cause. Participants without an event were censored at their last evaluable post-baseline tumor assessment if available, otherwise were censored on study Day 1. One month was calculated based on 365.25 days per year. \- PD: At least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. Unequivocal progression of existing non-target lesions.

Outcome measures

Outcome measures
Measure
Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance
n=26 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 plaque-forming units (PFU)/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an intravenous (IV) infusion every 3 weeks for up to 35 cycles.
Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance
n=15 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months
n=15 Participants
Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of \< 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months
n=15 Participants
Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Progression Free Survival (PFS) Per Modified RECIST v1.1
3.614 Months
Interval 2.793 to 5.52
4.830 Months
Interval 2.431 to 13.207
2.793 Months
Interval 2.661 to 27.433
13.897 Months
Interval 5.552 to 19.318

SECONDARY outcome

Timeframe: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

Population: Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination.

iPFS per modified irRC-RECIST was defined as the interval from first dose to the earlier event of iPD or death from any cause. Participants without an event were censored at their last evaluable post-baseline tumor assessment if available, otherwise were censored on study Day 1. One month was calculated based on 365.25 days per year. \- iPD: Increase in tumor burden ≥ 20% and at least 5 mm absolute increase.

Outcome measures

Outcome measures
Measure
Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance
n=26 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 plaque-forming units (PFU)/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an intravenous (IV) infusion every 3 weeks for up to 35 cycles.
Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance
n=15 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months
n=15 Participants
Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of \< 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months
n=15 Participants
Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Progression Free Survival (iPFS) Per Modified irRC-RECIST
6.899 Months
Interval 2.793 to 25.232
8.214 Months
Interval 2.694 to 15.014
NA Months
Interval 2.694 to
Median and upper limit of the 95% confidence limit were not estimable due to the low number of events (iPD or death).
25.955 Months
Interval 16.756 to
Upper limit of the 95% confidence limit was not estimable due to the low number of events (iPD or death).

SECONDARY outcome

Timeframe: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

Population: Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination.

OS was defined as the interval from first dose to death from any cause. Participants without an event were censored at the last date known to be alive. One month was calculated based on 365.25 days per year.

Outcome measures

Outcome measures
Measure
Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance
n=26 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 plaque-forming units (PFU)/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an intravenous (IV) infusion every 3 weeks for up to 35 cycles.
Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance
n=15 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months
n=15 Participants
Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of \< 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months
n=15 Participants
Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Overall Survival (OS)
24.608 Months
Interval 6.538 to 42.086
15.014 Months
Interval 2.76 to 38.374
NA Months
Interval 8.575 to
Median and upper limit of the 95% confidence interval were not estimable due to the low number of events.
NA Months
Interval 20.37 to
Median and upper limit of the 95% confidence interval were not estimable due to the low number of events.

SECONDARY outcome

Timeframe: Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.

Population: Safety Analysis Set: All enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.

Evaluation of TEAEs included the number of participants with at least 1: * TEAE * Treatment-related TEAE * Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 TEAE * Treatment-related CTCAE grade ≥ 3 TEAE * Serious TEAE * Serious treatment-related TEAE * Fatal TEAE * Fatal treatment-related TEAE * TEAE of interest Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. A CTCAE grade ≥ 3 was determined using the CTCAE grading systems based on CTCAE version 5.0 per the below definitions: * Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. * Grade 4: Life-threatening consequences; urgent intervention indicated. * Grade 5: Death related to TEAE. Abnormal laboratory tests were also recorded as TEAEs.

Outcome measures

Outcome measures
Measure
Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance
n=26 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 plaque-forming units (PFU)/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an intravenous (IV) infusion every 3 weeks for up to 35 cycles.
Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance
n=15 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months
n=15 Participants
Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of \< 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months
n=15 Participants
Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Serious Treatment-related TEAEs
1 Participants
2 Participants
0 Participants
3 Participants
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
TEAEs
24 Participants
15 Participants
15 Participants
14 Participants
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Treatment-related TEAEs
17 Participants
10 Participants
14 Participants
13 Participants
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
CTCAE Grade ≥ 3 TEAEs
11 Participants
8 Participants
4 Participants
8 Participants
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
CTCAE Grade ≥ 3 Treatment-related TEAEs
2 Participants
3 Participants
0 Participants
6 Participants
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Serious TEAEs
12 Participants
7 Participants
4 Participants
7 Participants
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Fatal TEAEs
5 Participants
3 Participants
1 Participants
3 Participants
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Fatal Treatment-related TEAEs
0 Participants
0 Participants
0 Participants
1 Participants
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
TEAEs of Interest
21 Participants
14 Participants
15 Participants
14 Participants

SECONDARY outcome

Timeframe: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

Population: Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination.

Time to first subsequent anti-cancer therapy was defined as the time from enrollment to the start of subsequent anticancer therapy. Participants who did not start subsequent anticancer therapy were censored as the last known to be alive date. One month was calculated based on 365.25 days per year.

Outcome measures

Outcome measures
Measure
Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance
n=26 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 plaque-forming units (PFU)/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an intravenous (IV) infusion every 3 weeks for up to 35 cycles.
Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance
n=15 Participants
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months
n=15 Participants
Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of \< 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months
n=15 Participants
Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Time to First Subsequent Anti-cancer Therapy
11.466 Months
Interval 6.209 to 38.111
7.852 Months
Interval 2.793 to
Upper limit of the 95% confidence interval was not estimable due to the low number of participants who received subsequent anti-cancer therapy.
NA Months
Interval 25.758 to
Median and upper limit of the 95% confidence interval were not estimable due to the low number of participants who received subsequent anti-cancer therapy.
23.097 Months
Interval 11.532 to
Upper limit of the 95% confidence interval was not estimable due to the low number of participants who received subsequent anti-cancer therapy.

Adverse Events

Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance

Serious events: 12 serious events
Other events: 20 other events
Deaths: 17 deaths

Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance

Serious events: 7 serious events
Other events: 15 other events
Deaths: 12 deaths

Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months

Serious events: 4 serious events
Other events: 15 other events
Deaths: 4 deaths

Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months

Serious events: 7 serious events
Other events: 14 other events
Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure
Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance
n=26 participants at risk
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance
n=15 participants at risk
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months
n=15 participants at risk
Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of \< 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months
n=15 participants at risk
Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Blood and lymphatic system disorders
Anaemia
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Blood and lymphatic system disorders
Thrombocytopenia
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Cardiac disorders
Bradycardia
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Cardiac disorders
Cardiac failure congestive
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Endocrine disorders
Adrenocortical insufficiency acute
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Gastrointestinal disorders
Diarrhoea
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Gastrointestinal disorders
Intussusception
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Gastrointestinal disorders
Pancreatitis
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
General disorders
Death
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
General disorders
General physical health deterioration
7.7%
2/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Hepatobiliary disorders
Liver injury
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
COVID-19
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
Cellulitis
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
Pneumonia bacterial
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
Respiratory tract infection
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
Sepsis
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
Septic shock
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Injury, poisoning and procedural complications
Fall
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Injury, poisoning and procedural complications
Subdural haematoma
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Metabolism and nutrition disorders
Dehydration
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Metabolism and nutrition disorders
Hypoglycaemia
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Musculoskeletal and connective tissue disorders
Pain in extremity
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
7.7%
2/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
11.5%
3/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Nervous system disorders
Brain oedema
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Nervous system disorders
Dizziness
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Renal and urinary disorders
Renal disorder
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Endocrine disorders
Hypophysitis
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
General disorders
Pyrexia
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Hepatobiliary disorders
Cholecystitis
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Skin and subcutaneous tissue disorders
Purpura
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.

Other adverse events

Other adverse events
Measure
Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance
n=26 participants at risk
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance
n=15 participants at risk
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months
n=15 participants at risk
Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of \< 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months
n=15 participants at risk
Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10\^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10\^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
Blood and lymphatic system disorders
Anaemia
15.4%
4/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Blood and lymphatic system disorders
Anaemia vitamin B12 deficiency
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Blood and lymphatic system disorders
Eosinophilia
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Ear and labyrinth disorders
Ear discomfort
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Endocrine disorders
Hypothyroidism
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Eye disorders
Conjunctival suffusion
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Eye disorders
Diplopia
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Eye disorders
Dry eye
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Eye disorders
Retinal disorder
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Eye disorders
Vision blurred
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Eye disorders
Xerophthalmia
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Gastrointestinal disorders
Abdominal distension
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Gastrointestinal disorders
Abdominal pain
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Gastrointestinal disorders
Anal haemorrhage
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Gastrointestinal disorders
Colitis
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Gastrointestinal disorders
Constipation
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Gastrointestinal disorders
Diarrhoea
11.5%
3/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
46.7%
7/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Gastrointestinal disorders
Dyspepsia
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Gastrointestinal disorders
Nausea
23.1%
6/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
26.7%
4/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
20.0%
3/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
20.0%
3/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Gastrointestinal disorders
Stomatitis
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Gastrointestinal disorders
Toothache
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Gastrointestinal disorders
Vomiting
15.4%
4/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
General disorders
Asthenia
11.5%
3/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
General disorders
Axillary pain
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
General disorders
Chest discomfort
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
General disorders
Chest pain
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
General disorders
Chills
23.1%
6/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
General disorders
Face oedema
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
General disorders
Fatigue
15.4%
4/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
33.3%
5/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
40.0%
6/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
33.3%
5/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
General disorders
Hyperthermia
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
General disorders
Influenza like illness
7.7%
2/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
46.7%
7/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
General disorders
Injection site extravasation
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
General disorders
Injection site haemorrhage
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
General disorders
Injection site inflammation
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
General disorders
Injection site oedema
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
General disorders
Injection site pain
11.5%
3/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
26.7%
4/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
General disorders
Injection site paraesthesia
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
General disorders
Injection site reaction
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
General disorders
Pain
7.7%
2/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
20.0%
3/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
General disorders
Peripheral swelling
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
General disorders
Pyrexia
26.9%
7/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
40.0%
6/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
33.3%
5/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
46.7%
7/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Hepatobiliary disorders
Cholestasis
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Hepatobiliary disorders
Hepatic cytolysis
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Immune system disorders
Contrast media allergy
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Immune system disorders
Sarcoidosis
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
Cellulitis
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
Cellulitis orbital
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
Clostridium difficile infection
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
Diarrhoea infectious
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
Enterocolitis infectious
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
Genital herpes simplex
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
Herpes simplex
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
Herpes simplex reactivation
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
Herpes zoster
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
Oral herpes
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
Respiratory tract infection
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
Rhinitis
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
Skin infection
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
Tinea versicolour
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
Upper respiratory tract infection
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
Wound infection
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Injury, poisoning and procedural complications
Accident at home
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Injury, poisoning and procedural complications
Head injury
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Injury, poisoning and procedural complications
Ligament sprain
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Injury, poisoning and procedural complications
Limb injury
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Injury, poisoning and procedural complications
Subdural haematoma
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Investigations
Alanine aminotransferase increased
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Investigations
Aspartate aminotransferase increased
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Investigations
Blood creatinine increased
7.7%
2/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Investigations
Blood pressure increased
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Investigations
Blood thyroid stimulating hormone increased
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Investigations
Body temperature increased
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Investigations
Gamma-glutamyltransferase increased
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Investigations
Lipase increased
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Investigations
Lymphocyte count decreased
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Investigations
Transaminases increased
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Investigations
Weight decreased
7.7%
2/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Metabolism and nutrition disorders
Decreased appetite
11.5%
3/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Metabolism and nutrition disorders
Gout
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Metabolism and nutrition disorders
Hyperglycaemia
7.7%
2/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Metabolism and nutrition disorders
Hypokalaemia
7.7%
2/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Metabolism and nutrition disorders
Hypomagnesaemia
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Metabolism and nutrition disorders
Hypophosphataemia
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Musculoskeletal and connective tissue disorders
Arthralgia
11.5%
3/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
26.7%
4/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Musculoskeletal and connective tissue disorders
Arthritis
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
20.0%
3/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Musculoskeletal and connective tissue disorders
Back pain
7.7%
2/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
26.7%
4/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Musculoskeletal and connective tissue disorders
Bone pain
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Musculoskeletal and connective tissue disorders
Compartment syndrome
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Musculoskeletal and connective tissue disorders
Joint effusion
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Musculoskeletal and connective tissue disorders
Myalgia
11.5%
3/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
26.7%
4/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Musculoskeletal and connective tissue disorders
Pain in extremity
15.4%
4/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
20.0%
3/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Musculoskeletal and connective tissue disorders
Rheumatic disorder
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Musculoskeletal and connective tissue disorders
Tendonitis
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Nervous system disorders
Dizziness
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Nervous system disorders
Headache
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
33.3%
5/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Nervous system disorders
Lethargy
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Nervous system disorders
Migraine
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Nervous system disorders
Paraesthesia
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Nervous system disorders
Peripheral sensory neuropathy
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Nervous system disorders
Syncope
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Psychiatric disorders
Delirium
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Psychiatric disorders
Depressed mood
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Psychiatric disorders
Depression
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Psychiatric disorders
Sleep disorder
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Renal and urinary disorders
Dysuria
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Renal and urinary disorders
Pollakiuria
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Renal and urinary disorders
Proteinuria
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Renal and urinary disorders
Urethral dilatation
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Reproductive system and breast disorders
Cervical dysplasia
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
20.0%
3/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Skin and subcutaneous tissue disorders
Dermatitis contact
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Skin and subcutaneous tissue disorders
Eczema
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Skin and subcutaneous tissue disorders
Hair colour changes
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Skin and subcutaneous tissue disorders
Pruritus
7.7%
2/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
33.3%
5/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Skin and subcutaneous tissue disorders
Rash
7.7%
2/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
26.7%
4/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Skin and subcutaneous tissue disorders
Scab
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Skin and subcutaneous tissue disorders
Skin hyperplasia
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Skin and subcutaneous tissue disorders
Skin hypopigmentation
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Skin and subcutaneous tissue disorders
Skin lesion
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Skin and subcutaneous tissue disorders
Umbilical discharge
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Skin and subcutaneous tissue disorders
Vitiligo
7.7%
2/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
20.0%
3/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Surgical and medical procedures
Skin neoplasm excision
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Vascular disorders
Hypotension
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Blood and lymphatic system disorders
Leukopenia
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Endocrine disorders
Hyperthyroidism
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Endocrine disorders
Hypophysitis
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Gastrointestinal disorders
Change of bowel habit
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Gastrointestinal disorders
Dry mouth
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Gastrointestinal disorders
Dysphagia
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Gastrointestinal disorders
Enteritis
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Gastrointestinal disorders
Gastritis
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Gastrointestinal disorders
Haemorrhoids
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
General disorders
Oedema peripheral
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
General disorders
Xerosis
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Immune system disorders
Seasonal allergy
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
COVID-19
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
Cystitis
7.7%
2/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
Dermatophytosis
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
Fungal skin infection
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
Mastoiditis
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
Postoperative wound infection
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Infections and infestations
Vaginal infection
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Injury, poisoning and procedural complications
Immunisation reaction
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Injury, poisoning and procedural complications
Skin laceration
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Injury, poisoning and procedural complications
Skin wound
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Injury, poisoning and procedural complications
Wound dehiscence
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Investigations
Blood creatine phosphokinase increased
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Metabolism and nutrition disorders
Hyperuricaemia
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Metabolism and nutrition disorders
Hyponatraemia
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Musculoskeletal and connective tissue disorders
Joint stiffness
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour fistulisation
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Nervous system disorders
Sciatica
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Psychiatric disorders
Anxiety
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Psychiatric disorders
Insomnia
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Reproductive system and breast disorders
Penile dermatitis
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Skin and subcutaneous tissue disorders
Dermatitis allergic
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Skin and subcutaneous tissue disorders
Lichen planus
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Skin and subcutaneous tissue disorders
Psoriasis
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Skin and subcutaneous tissue disorders
Rash erythematous
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Skin and subcutaneous tissue disorders
Rash macular
3.8%
1/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Skin and subcutaneous tissue disorders
Rash papular
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
13.3%
2/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Skin and subcutaneous tissue disorders
Rash pruritic
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Skin and subcutaneous tissue disorders
Skin burning sensation
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Vascular disorders
Hypertension
0.00%
0/26 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
6.7%
1/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
0.00%
0/15 • Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

  • Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
  • Publication restrictions are in place

Restriction type: OTHER