Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02014441
Recruitment Status : Completed
First Posted : December 18, 2013
Results First Posted : February 14, 2017
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Melanoma
Intervention Drug: Talimogene laherparepvec
Enrollment 61
Recruitment Details This study was conducted at 11 centers in the United States and Canada. The first participant was enrolled on 07 April 2014 and the last participant was enrolled on 07 December 2015.
Pre-assignment Details  
Arm/Group Title Talimogene Laherparepvec
Hide Arm/Group Description Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Period Title: Overall Study
Started 61
Received Treatment 60
Completed 49
Not Completed 12
Reason Not Completed
Withdrawal by Subject             12
Arm/Group Title Talimogene Laherparepvec
Hide Arm/Group Description Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
Safety analysis set (all participants who received at least 1 dose of talimogene laherparepvec)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants
63.3  (16.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
27
  45.0%
Male
33
  55.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
White
60
 100.0%
Eastern Cooperative Oncology Group (ECOG) Performance   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
0 (Fully active)
45
  75.0%
1 (Restrictive but ambulatory)
15
  25.0%
[1]
Measure Description:

Scale to assess a patient's disease status.

  • 0 = Fully active, able to carry on all pre-disease performance without restriction;
  • 1 = Restricted in physically strenuous activity, ambulatory, able to carry out work of a light nature;
  • 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about > 50% of waking hours;
  • 3 = Capable of only limited self care, confined to a bed or chair > 50% of waking hours;
  • 4 = Completely disabled, confined to bed or chair;
  • 5 = Dead.
Herpes Simplex Virus Type 1 (HSV-1) Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Negative
17
  28.3%
Positive
40
  66.7%
Unknown
3
   5.0%
[1]
Measure Description: HSV-1 status at baseline was determined by HSV-1 iimmunoglobulin G (IgG).
1.Primary Outcome
Title Percentage of Participants With Detectable Talimogene Laherparepvec Deoxyribonucleic Acid (DNA) During the First Three Cycles
Hide Description Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA in blood or urine at any time during cycles 1 to 3 is reported. The first cycle was 21 days in length, and subsequent cycles were 14 days in length.
Time Frame Cycles 1 and 2 on days 1 (pre-dose and 1, 4, and 8 hours post-dose), 2, 3, 8, and 15 (cycle 1 only), cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled, received at least 1 dose of talimogene laherparepvec, and had at least 1 postdose blood/urine sample collected.
Arm/Group Title Talimogene Laherparepvec Talimogene Laherparepvec: HSV-1 Negative Talimogene Laherparepvec: HSV-1 Positive
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Participants who were seronegative at baseline for HSV-1.
Participants who were seropositive at baseline for HSV-1.
Overall Number of Participants Analyzed 60 17 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Blood
98.3
(91.1 to 100.0)
100.0
(80.5 to 100.0)
97.5
(86.8 to 99.9)
Urine
31.7
(20.3 to 45.0)
29.4
(10.3 to 56.0)
35.0
(20.6 to 51.7)
2.Secondary Outcome
Title Percentage of Participants With Clearance of Talimogene Laherparepvec DNA From Blood
Hide Description A participant was defined as having cleared talimogene laherparepvec if a negative blood sample was obtained following a prior positive test and if there were no subsequent positive tests.
Time Frame Cycles 1 and 2 on days 1 (pre-dose and 1, 4, and 8 hours post-dose), 2, 3, 8, and 15 (cycle 1 only), cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants must have received at least 1 dose of talimogene laherparepvec, had at least 2 post-dose blood samples collected within the same dosing cycle with at least 1 positive talimogene laherparepvec DNA sample and at least 1 subsequent sample at any time during the cycle.
Arm/Group Title Talimogene Laherparepvec Talimogene Laherparepvec: HSV-1 Negative Talimogene Laherparepvec: HSV-1 Positive
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Participants who were seronegative at baseline for HSV-1.
Participants who were seropositive at baseline for HSV-1.
Overall Number of Participants Analyzed 59 17 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Cycle 1 Number Analyzed 41 participants 14 participants 25 participants
92.7
(80.1 to 98.5)
78.6
(49.2 to 95.3)
100.0
(86.3 to 100.0)
Cycle 2 Number Analyzed 57 participants 17 participants 38 participants
86.0
(74.2 to 93.7)
64.7
(38.3 to 85.8)
94.7
(82.3 to 99.4)
Cycle 3 Number Analyzed 3 participants 2 participants 1 participants
33.3
(0.8 to 90.6)
50.0
(1.3 to 98.7)
0.0
(0.0 to 97.5)
3.Secondary Outcome
Title Percentage of Participants With Clearance of Talimogene Laherparepvec DNA From Urine
Hide Description A participant was defined as having cleared talimogene laherparepvec if a negative urine sample was obtained following a prior positive test and if there were no subsequent positive tests.
Time Frame Cycles 1 and 2 on days 1 (pre-dose and 1, 4, and 8 hours post-dose), 2, 3, 8, and 15 (cycle 1 only), cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants received at least 1 dose of talimogene laherparepvec, had at least 2 post-dose urine samples collected within the same dosing cycle with at least 1 positive talimogene laherparepvec DNA sample and at least 1 subsequent sample at any time during the cycle.
Arm/Group Title Talimogene Laherparepvec Talimogene Laherparepvec: HSV-1 Negative Talimogene Laherparepvec: HSV-1 Positive
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Participants who were seronegative at baseline for HSV-1.
Participants who were seropositive at baseline for HSV-1.
Overall Number of Participants Analyzed 18 4 14
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Cycle 1 Number Analyzed 3 participants 1 participants 2 participants
100.0
(29.2 to 100.0)
100.0
(2.5 to 100.0)
100.0
(15.8 to 100.0)
Cycle 2 Number Analyzed 14 participants 3 participants 11 participants
92.9
(66.1 to 99.8)
100.0
(29.2 to 100.0)
90.9
(58.7 to 99.8)
Cycle 3 Number Analyzed 2 participants 0 participants 2 participants
100.0
(15.8 to 100.0)
100.0
(15.8 to 100.0)
4.Secondary Outcome
Title Percentage of Samples With Detectable Talimogene Laherparepvec DNA on the Exterior of the Occlusive Dressing During the First Three Cycles
Hide Description Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from the exterior of the occlusive dressing with detectable talimogene laherparepvec DNA at any time during cycles 1 to 3 is reported.
Time Frame Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing.
Arm/Group Title Talimogene Laherparepvec Talimogene Laherparepvec: HSV-1 Negative Talimogene Laherparepvec: HSV-1 Positive
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Participants who were seronegative at baseline for HSV-1.
Participants who were seropositive at baseline for HSV-1.
Overall Number of Participants Analyzed 60 17 40
Overall Number of Units Analyzed
Type of Units Analyzed: Samples
1085 289 741
Measure Type: Number
Unit of Measure: percentage of samples
19.5 17.6 19.6
5.Secondary Outcome
Title Percentage of Samples With Detectable Talimogene Laherparepvec Virus on the Exterior of the Occlusive Dressing During the First Three Cycles
Hide Description If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of swab samples from the exterior of the occlusive dressing with detectable talimogene laherparepvec virus at any time during cycles 1 to 3 is reported.
Time Frame Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing with a detectable qPCR result.
Arm/Group Title Talimogene Laherparepvec Talimogene Laherparepvec: HSV-1 Negative Talimogene Laherparepvec: HSV-1 Positive
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Participants who were seronegative at baseline for HSV-1.
Participants who were seropositive at baseline for HSV-1.
Overall Number of Participants Analyzed 48 13 33
Overall Number of Units Analyzed
Type of Units Analyzed: Samples
211 51 144
Measure Type: Number
Unit of Measure: percentage of samples
0.0 0.0 0.0
6.Secondary Outcome
Title Percentage of Participants With Detectable Talimogene Laherparepvec DNA on the Exterior of the Occlusive Dressing During the First Three Cycles
Hide Description Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA on the exterior of the occlusive dressing at any time during cycles 1 to 3 is reported.
Time Frame Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing.
Arm/Group Title Talimogene Laherparepvec Talimogene Laherparepvec: HSV-1 Negative Talimogene Laherparepvec: HSV-1 Positive
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Participants who were seronegative at baseline for HSV-1.
Participants who were seropositive at baseline for HSV-1.
Overall Number of Participants Analyzed 60 17 40
Measure Type: Number
Unit of Measure: percentage of participants
80.0 76.5 82.5
7.Secondary Outcome
Title Percentage of Participants With Detectable Talimogene Laherparepvec Virus on the Exterior of the Occlusive Dressing During the First Three Cycles
Hide Description If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of participants with detectable talimogene laherparepvec virus on the exterior of the occlusive dressing at any time during cycles 1 to 3 is reported.
Time Frame Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing with a detectable qPCR result.
Arm/Group Title Talimogene Laherparepvec Talimogene Laherparepvec: HSV-1 Negative Talimogene Laherparepvec: HSV-1 Positive
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Participants who were seronegative at baseline for HSV-1.
Participants who were seropositive at baseline for HSV-1.
Overall Number of Participants Analyzed 48 13 33
Measure Type: Number
Unit of Measure: percentage of participants
0.0 0.0 0.0
8.Secondary Outcome
Title Percentage of Samples From the Surface of Injected Lesions With Detectable Talimogene Laherparepvec DNA During the First Three Cycles
Hide Description Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from the surface of injected lesions with detectable talimogene laherparepvec DNA at any time during cycles 1 to 3 is reported.
Time Frame Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one injected lesion swab collected.
Arm/Group Title Talimogene Laherparepvec Talimogene Laherparepvec: HSV-1 Negative Talimogene Laherparepvec: HSV-1 Positive
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Participants who were seronegative at baseline for HSV-1.
Participants who were seropositive at baseline for HSV-1.
Overall Number of Participants Analyzed 60 17 40
Overall Number of Units Analyzed
Type of Units Analyzed: Samples
1260 307 885
Measure Type: Number
Unit of Measure: percentage of samples
57.6 53.7 57.3
9.Secondary Outcome
Title Percentage of Samples From the Surface of Injected Lesions With Detectable Talimogene Laherparepvec Virus During the First Three Cycles
Hide Description If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of samples taken from the surface of injected lesions with detectable talimogene laherparepvec virus at any time during cycles 1 to 3 is reported.
Time Frame Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one injected lesion swab collected with a positive qPCR result.
Arm/Group Title Talimogene Laherparepvec Talimogene Laherparepvec: HSV-1 Negative Talimogene Laherparepvec: HSV-1 Positive
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Participants who were seronegative at baseline for HSV-1.
Participants who were seropositive at baseline for HSV-1.
Overall Number of Participants Analyzed 60 17 40
Overall Number of Units Analyzed
Type of Units Analyzed: Samples
725 165 506
Measure Type: Number
Unit of Measure: percentage of samples
1.1 3.0 0.6
10.Secondary Outcome
Title Percentage of Participants With Detectable Talimogene Laherparepvec DNA on the Surface of Injected Lesions During the First Three Cycles
Hide Description Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA swabs taken from the surface of injected lesions at any time during cycles 1 to 3 is reported.
Time Frame Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one injected lesion swab collected.
Arm/Group Title Talimogene Laherparepvec Talimogene Laherparepvec: HSV-1 Negative Talimogene Laherparepvec: HSV-1 Positive
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Participants who were seronegative at baseline for HSV-1.
Participants who were seropositive at baseline for HSV-1.
Overall Number of Participants Analyzed 60 17 40
Measure Type: Number
Unit of Measure: percentage of participants
100.0 100.0 100.0
11.Secondary Outcome
Title Percentage of Participants With Detectable Talimogene Laherparepvec Virus on the Surface of Injected Lesions During the First Three Cycles
Hide Description If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of participants with detectable talimogene laherparepvec virus on swabs taken from the surface of injected lesions at any time during cycles 1 to 3 is reported.
Time Frame Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one injected lesion swab collected with a positive qPCR result.
Arm/Group Title Talimogene Laherparepvec Talimogene Laherparepvec: HSV-1 Negative Talimogene Laherparepvec: HSV-1 Positive
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Participants who were seronegative at baseline for HSV-1.
Participants who were seropositive at baseline for HSV-1.
Overall Number of Participants Analyzed 60 17 40
Measure Type: Number
Unit of Measure: percentage of participants
11.7 23.5 7.5
12.Secondary Outcome
Title Percentage of Samples From Oral Mucosa With Detectable Talimogene Laherparepvec DNA During Treatment
Hide Description Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from oral mucosa with detectable talimogene laherparepvec DNA at any time during treatment is reported.
Time Frame Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 47) on day 1 (pre-dose), cycle 25 on day 1 (pre-dose) and day 8.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected during treatment.
Arm/Group Title Talimogene Laherparepvec Talimogene Laherparepvec: HSV-1 Negative Talimogene Laherparepvec: HSV-1 Positive
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Participants who were seronegative at baseline for HSV-1.
Participants who were seropositive at baseline for HSV-1.
Overall Number of Participants Analyzed 60 17 40
Overall Number of Units Analyzed
Type of Units Analyzed: Samples
964 302 599
Measure Type: Number
Unit of Measure: percentage of samples
1.2 2.6 0.5
13.Secondary Outcome
Title Percentage of Samples From Oral Mucosa With Detectable Talimogene Laherparepvec Virus During Treatment
Hide Description If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of samples taken from oral mucosa with detectable talimogene laherparepvec virus at any time during treatment is reported.
Time Frame Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 47) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected during treatment with a positive qPCR result.
Arm/Group Title Talimogene Laherparepvec Talimogene Laherparepvec: HSV-1 Negative Talimogene Laherparepvec: HSV-1 Positive
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Participants who were seronegative at baseline for HSV-1.
Participants who were seropositive at baseline for HSV-1.
Overall Number of Participants Analyzed 8 4 3
Overall Number of Units Analyzed
Type of Units Analyzed: Samples
12 8 3
Measure Type: Number
Unit of Measure: percentage of samples
0.0 0.0 0.0
14.Secondary Outcome
Title Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Oral Mucosa During Treatment
Hide Description Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA on swabs taken from oral mucosa at any time during treatment is reported.
Time Frame Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 47) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected during treatment.
Arm/Group Title Talimogene Laherparepvec Talimogene Laherparepvec: HSV-1 Negative Talimogene Laherparepvec: HSV-1 Positive
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Participants who were seronegative at baseline for HSV-1.
Participants who were seropositive at baseline for HSV-1.
Overall Number of Participants Analyzed 60 17 40
Measure Type: Number
Unit of Measure: percentage of participants
13.3 23.5 7.5
15.Secondary Outcome
Title Percentage of Participants With Detectable Talimogene Laherparepvec Virus in Oral Mucosa During Treatment
Hide Description If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of participants with detectable talimogene laherparepvec virus in swabs taken from oral mucosa at any time during treatment is reported.
Time Frame Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 47) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected during treatment with a positive qPCR result.
Arm/Group Title Talimogene Laherparepvec Talimogene Laherparepvec: HSV-1 Negative Talimogene Laherparepvec: HSV-1 Positive
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Participants who were seronegative at baseline for HSV-1.
Participants who were seropositive at baseline for HSV-1.
Overall Number of Participants Analyzed 8 4 3
Measure Type: Number
Unit of Measure: percentage of participants
0.0 0.0 0.0
16.Secondary Outcome
Title Percentage of Samples From the Anogenital Area With Detectable Talimogene Laherparepvec DNA During Treatment
Hide Description Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from the anogenital area with detectable talimogene laherparepvec DNA at any time during treatment is reported.
Time Frame Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 50) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected during treatment.
Arm/Group Title Talimogene Laherparepvec Talimogene Laherparepvec: HSV-1 Negative Talimogene Laherparepvec: HSV-1 Positive
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Participants who were seronegative at baseline for HSV-1.
Participants who were seropositive at baseline for HSV-1.
Overall Number of Participants Analyzed 26 7 17
Overall Number of Units Analyzed
Type of Units Analyzed: Samples
448 123 244
Measure Type: Number
Unit of Measure: percentage of samples
1.6 0.0 2.9
17.Secondary Outcome
Title Percentage of Samples With Detectable Talimogene Laherparepvec Virus in Swabs From the Anogenital Area During Treatment
Hide Description If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of samples with detectable talimogene laherparepvec virus in swabs taken from the anogenital area at any time during treatment is reported.
Time Frame Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 50) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected during treatment with a positive qPCR result.
Arm/Group Title Talimogene Laherparepvec Talimogene Laherparepvec: HSV-1 Negative Talimogene Laherparepvec: HSV-1 Positive
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Participants who were seronegative at baseline for HSV-1.
Participants who were seropositive at baseline for HSV-1.
Overall Number of Participants Analyzed 5 0 5
Overall Number of Units Analyzed
Type of Units Analyzed: Samples
7 0 7
Measure Type: Number
Unit of Measure: percentage of samples
0.0 0.0
18.Secondary Outcome
Title Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Swabs From the Anogenital Area During Treatment
Hide Description Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA in swabs from the anogenital area at any time during treatment is reported.
Time Frame Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 50) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected during treatment.
Arm/Group Title Talimogene Laherparepvec Talimogene Laherparepvec: HSV-1 Negative Talimogene Laherparepvec: HSV-1 Positive
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Participants who were seronegative at baseline for HSV-1.
Participants who were seropositive at baseline for HSV-1.
Overall Number of Participants Analyzed 26 7 17
Measure Type: Number
Unit of Measure: percentage of participants
19.2 0.0 29.4
19.Secondary Outcome
Title Percentage of Participants With Detectable Talimogene Laherparepvec Virus in Swabs From the Anogenital Area During Treatment
Hide Description If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of participants with detectable talimogene laherparepvec virus in swabs taken from the anogenital area at any time during treatment is reported.
Time Frame Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 50) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected during treatment with a positive qPCR result.
Arm/Group Title Talimogene Laherparepvec Talimogene Laherparepvec: HSV-1 Negative Talimogene Laherparepvec: HSV-1 Positive
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Participants who were seronegative at baseline for HSV-1.
Participants who were seropositive at baseline for HSV-1.
Overall Number of Participants Analyzed 5 0 5
Measure Type: Number
Unit of Measure: percentage of participants
0.0 0.0
20.Secondary Outcome
Title Percentage of Samples From Oral Mucosa With Detectable Talimogene Laherparepvec DNA After the End of Treatment
Hide Description Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from oral mucosa with detectable talimogene laherparepvec DNA after the end of treatment is reported.
Time Frame From 30 to 60 days after the last dose of talimogene laherparepvec (the median [minimum, maximum] duration of treatment was 23 [3, 141] weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected after the end of treatment.
Arm/Group Title Talimogene Laherparepvec Talimogene Laherparepvec: HSV-1 Negative Talimogene Laherparepvec: HSV-1 Positive
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Participants who were seronegative at baseline for HSV-1.
Participants who were seropositive at baseline for HSV-1.
Overall Number of Participants Analyzed 52 16 35
Overall Number of Units Analyzed
Type of Units Analyzed: Samples
981 284 667
Measure Type: Number
Unit of Measure: percentage of samples
0.0 0.0 0.0
21.Secondary Outcome
Title Percentage of Samples From Oral Mucosa With Detectable Talimogene Laherparepvec Virus After the End of Treatment
Hide Description If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity.
Time Frame From 30 to 60 days after the last dose of talimogene laherparepvec (the median [minimum, maximum] duration of treatment was 23 [3, 141] weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected after the end of treatment with a positive qPCR result.
Arm/Group Title Talimogene Laherparepvec Talimogene Laherparepvec: HSV-1 Negative Talimogene Laherparepvec: HSV-1 Positive
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Participants who were seronegative at baseline for HSV-1.
Participants who were seropositive at baseline for HSV-1.
Overall Number of Participants Analyzed 0 0 0
Overall Number of Units Analyzed
Type of Units Analyzed: Samples
0 0 0
No data displayed because Outcome Measure has zero total analyzed.
22.Secondary Outcome
Title Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Oral Mucosa After the End of Treatment
Hide Description Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA in swabs taken from oral mucosa after the end of treatment is reported.
Time Frame From 30 to 60 days after the last dose of talimogene laherparepvec (the median [minimum, maximum] duration of treatment was 23 [3, 141] weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected after the end of treatment.
Arm/Group Title Talimogene Laherparepvec Talimogene Laherparepvec: HSV-1 Negative Talimogene Laherparepvec: HSV-1 Positive
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Participants who were seronegative at baseline for HSV-1.
Participants who were seropositive at baseline for HSV-1.
Overall Number of Participants Analyzed 52 16 35
Measure Type: Number
Unit of Measure: percentage of participants
0.0 0.0 0.0
23.Secondary Outcome
Title Percentage of Participants With Detectable Talimogene Laherparepvec Virus in Oral Mucosa After the End of Treatment
Hide Description If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity.
Time Frame From 30 to 60 days after the last dose of talimogene laherparepvec (the median [minimum, maximum] duration of treatment was 23 [3, 141] weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected after the end of treatment with a positive qPCR result.
Arm/Group Title Talimogene Laherparepvec Talimogene Laherparepvec: HSV-1 Negative Talimogene Laherparepvec: HSV-1 Positive
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Participants who were seronegative at baseline for HSV-1.
Participants who were seropositive at baseline for HSV-1.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
24.Secondary Outcome
Title Percentage of Samples From the Anogenital Area With Detectable Talimogene Laherparepvec DNA After the End of Treatment
Hide Description Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from the anogenital area with detectable talimogene laherparepvec DNA after the end of treatment is reported.
Time Frame From 30 to 60 days after the last dose of talimogene laherparepvec (the median [minimum, maximum] duration of treatment was 23 [3, 141] weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected after end of treatment.
Arm/Group Title Talimogene Laherparepvec Talimogene Laherparepvec: HSV-1 Negative Talimogene Laherparepvec: HSV-1 Positive
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Participants who were seronegative at baseline for HSV-1.
Participants who were seropositive at baseline for HSV-1.
Overall Number of Participants Analyzed 21 7 13
Overall Number of Units Analyzed
Type of Units Analyzed: Samples
515 187 326
Measure Type: Number
Unit of Measure: percentage of samples
0.0 0.0 0.0
25.Secondary Outcome
Title Percentage of Samples From the Anogenital Area With Detectable Talimogene Laherparepvec Virus After the End of Treatment
Hide Description If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity.
Time Frame 30 toFrom 30 to 60 days after the last dose of talimogene laherparepvec (the median [minimum, maximum] duration of treatment was 23 [3, 141] weeks). 60 days after the last dose of talimogene laherparepvec.
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected after the end of treatment with a positive qPCR result.
Arm/Group Title Talimogene Laherparepvec Talimogene Laherparepvec: HSV-1 Negative Talimogene Laherparepvec: HSV-1 Positive
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Participants who were seronegative at baseline for HSV-1.
Participants who were seropositive at baseline for HSV-1.
Overall Number of Participants Analyzed 0 0 0
Overall Number of Units Analyzed
Type of Units Analyzed: Samples
0 0 0
No data displayed because Outcome Measure has zero total analyzed.
26.Secondary Outcome
Title Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Swabs From the Anogenital Area After the End of Treatment
Hide Description Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA in swabs from the anogenital area after the end of treatment is reported.
Time Frame From 30 to 60 days after the last dose of talimogene laherparepvec (the median [minimum, maximum] duration of treatment was 23 [3, 141] weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected after the end of treatment.
Arm/Group Title Talimogene Laherparepvec Talimogene Laherparepvec: HSV-1 Negative Talimogene Laherparepvec: HSV-1 Positive
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Participants who were seronegative at baseline for HSV-1.
Participants who were seropositive at baseline for HSV-1.
Overall Number of Participants Analyzed 21 7 13
Measure Type: Number
Unit of Measure: percentage of participants
0.0 0.0 0.0
27.Secondary Outcome
Title Percentage of Participants With Detectable Talimogene Laherparepvec Virus in Swabs From the Anogenital Area After the End of Treatment
Hide Description If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity.
Time Frame From 30 to 60 days after the last dose of talimogene laherparepvec (the median [minimum, maximum] duration of treatment was 23 [3, 141] weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected after the end of treatment with a positive qPCR result.
Arm/Group Title Talimogene Laherparepvec Talimogene Laherparepvec: HSV-1 Negative Talimogene Laherparepvec: HSV-1 Positive
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Participants who were seronegative at baseline for HSV-1.
Participants who were seropositive at baseline for HSV-1.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
28.Secondary Outcome
Title Number of Samples With Detectable Talimogene Laherparepvec in Lesions Suspected to be Herpetic in Origin
Hide Description Any lesion such as a cold sore or vesicle thought to be herpetic in origin was evaluated by the investigator and swabbed if HSV infection was suspected. Quantitative PCR was performed on the swab sample to evaluate whether talimogene laherparepvec DNA was detectable in the sample.
Time Frame From first dose until 60 days after last dose of talimogene laherparepvec; The median actual follow-up time was 28.9 weeks (range: 4 to 151 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab sample collected from lesions suspected to be herpetic in origin during the study.
Arm/Group Title Talimogene Laherparepvec
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Overall Number of Participants Analyzed 19
Overall Number of Units Analyzed
Type of Units Analyzed: Samples
37
Measure Type: Number
Unit of Measure: samples
4
29.Secondary Outcome
Title Best Overall Response
Hide Description

Response was assessed according to modified World Health Organization (WHO) criteria using both clinical (cutaneous, subcutaneous, or nodal tumor measurement by caliper) and radiological imaging (computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound of the chest, abdomen, and pelvis and all other sites of disease).

Complete response: disappearance of all index and non-index lesions.

Partial Response: ≥ 50% reduction in size of all index lesions and any new measurable lesions.

Stable disease: Neither sufficient tumor shrinkage of index lesion to qualify for response nor sufficient tumor increase of index lesion to qualify for progressive disease, assessed a minimum interval of 77 days from the first dose of study drug.

Progressive Disease: ≥ 25% increase in size of index lesions or appearance of one or more non-index lesions.

Time Frame Tumor response was assessed at weeks 12 and 24 and then at least every 3 months up to the end of treatment; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of talimogene laherparepvec.
Arm/Group Title Talimogene Laherparepvec
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: participants
Complete Response 9
Partial Response 12
Stable Disease 10
Progressive Disease 26
Unevaluable 1
Not Done 2
30.Secondary Outcome
Title Objective Response Rate
Hide Description

Response was assessed according to modified World Health Organization (WHO) criteria using both clinical (cutaneous, subcutaneous, or nodal tumor measurement by caliper) and radiological imaging (computed tomography, magnetic resonance imaging or ultrasound of the chest, abdomen, and pelvis and all other sites of disease). Objective response rate is defined as the percentage of participants with either a complete response or partial response. Subsequent confirmation was not required.

Complete response: disappearance of all index and non-index lesions.

Partial Response: ≥ 50% reduction in size of all index lesions and any new measurable lesions.

Time Frame Tumor response was assessed at weeks 12 and 24 and then at least every 3 months up to the end of treatment; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of talimogene laherparepvec.
Arm/Group Title Talimogene Laherparepvec
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
35.0
(23.1 to 48.4)
31.Secondary Outcome
Title Time to Response
Hide Description Time to response was defined as the interval from the first dose of talimogene laherparepvec to the first event of complete response or partial response per modified WHO criteria; participants who did not respond were censored at the last evaluable tumor assessment.
Time Frame Tumor response was assessed at weeks 12 and 24 and then at least every 3 months up to the end of treatment; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of talimogene laherparepvec.
Arm/Group Title Talimogene Laherparepvec
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Overall Number of Participants Analyzed 60
Median (95% Confidence Interval)
Unit of Measure: months
8.7 [1] 
(5.3 to NA)
[1]
Could not be estimated due to the low number of events
32.Secondary Outcome
Title Duration of Response
Hide Description Duration of response (DOR) was calculated only for those participants with an objective response and defined as the longest interval from an initial objective response (complete response or partial response) to disease progression per the modified WHO criteria or death, whichever occurred earlier; otherwise, DOR was censored at the last evaluable tumor assessment for participants who did not die or progress.
Time Frame Tumor response was assessed at weeks 12 and 24 and then at least every 3 months up to the end of treatment; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of talimogene laherparepvec and had an objective response.
Arm/Group Title Talimogene Laherparepvec
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Overall Number of Participants Analyzed 21
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
[1]
Could not be estimated due to the low number of events
33.Secondary Outcome
Title Durable Response Rate
Hide Description

Response was assessed according to modified World Health Organization (WHO) criteria using both clinical (cutaneous, subcutaneous, or nodal tumor measurement by caliper) and radiological imaging (computed tomography, magnetic resonance imaging or ultrasound of the chest, abdomen, and pelvis and all other sites of disease). Durable response rate is defined as the percentage of participants with a complete response or partial response maintained continuously for at least 6 months (183 days).

Complete response: disappearance of all index and non-index lesions.

Partial Response:≥ 50% reduction in size of all index lesions and any new measurable lesions.

Time Frame Tumor response was assessed at weeks 12 and 24 and then at least every 3 months up to the end of treatment; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of talimogene laherparepvec.
Arm/Group Title Talimogene Laherparepvec
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5.0
(1.0 to 13.9)
34.Secondary Outcome
Title Overall Survival
Hide Description Overall Survival (OS) was defined as the interval from first dose of talimogene laherparepvec to death from any cause; participants still alive were censored at the last known alive date.
Time Frame From first dose until 60 days after last dose of talimogene laherparepvec; The median actual follow-up time was 28.9 weeks (range: 4 to 151 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of talimogene laherparepvec.
Arm/Group Title Talimogene Laherparepvec
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Overall Number of Participants Analyzed 60
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
[1]
Could not be estimated due to the low number of events
35.Secondary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description

The Common Terminology Criteria for Adverse Events version 3.0 was used to grade severity of adverse events, based on the following general guideline: Grade 1 = Mild AE Grade 2 = Moderate AE Grade 3 = Severe AE Grade 4 = Life-threatening or disabling AE Grade 5 = Death related to AE. A serious adverse event was defined as an adverse event that meets at least 1 of the following serious criteria:

  • fatal
  • life threatening
  • requires in-patient hospitalization or prolongation of existing hospitalization
  • results in persistent or significant disability/incapacity
  • congenital anomaly/birth defect
  • other medically important serious event

Treatment-related adverse events (TRAEs) are defined as adverse events possibly caused by talimogene laherparepvec, as assessed by the investigator.

Time Frame From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of talimogene laherparepvec.
Arm/Group Title Talimogene Laherparepvec
Hide Arm/Group Description:
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
Overall Number of Participants Analyzed 60
Measure Type: Count of Participants
Unit of Measure: Participants
Any adverse event
60
 100.0%
AE grade ≥ 2
42
  70.0%
AE grade ≥ 3
12
  20.0%
AE grade ≥ 4
1
   1.7%
Serious adverse events
13
  21.7%
AE leading to study drug discontinuation
5
   8.3%
Fatal AE
0
   0.0%
Treatment-related adverse event
57
  95.0%
Treatment-related AE grade ≥ 2
33
  55.0%
Treatment-related AE grade ≥ 3
6
  10.0%
Treatment-related AE grade ≥ 4
1
   1.7%
Serious treatment-related AE
8
  13.3%
TRAE leading to study drug discontinuation
3
   5.0%
Fatal treatment-related AE
0
   0.0%
Time Frame From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title Talimogene Laherparepvec
Hide Arm/Group Description Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
All-Cause Mortality
Talimogene Laherparepvec
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Talimogene Laherparepvec
Affected / at Risk (%)
Total   13/60 (21.67%) 
Cardiac disorders   
Atrial fibrillation  1  1/60 (1.67%) 
Cardiac failure congestive  1  1/60 (1.67%) 
Gastrointestinal disorders   
Abdominal pain upper  1  1/60 (1.67%) 
General disorders   
Influenza like illness  1  1/60 (1.67%) 
Pyrexia  1  2/60 (3.33%) 
Hepatobiliary disorders   
Cholelithiasis  1  1/60 (1.67%) 
Infections and infestations   
Cellulitis  1  1/60 (1.67%) 
Pneumonia  1  1/60 (1.67%) 
Sepsis  1  1/60 (1.67%) 
Skin infection  1  1/60 (1.67%) 
Investigations   
Body temperature increased  1  1/60 (1.67%) 
Nervous system disorders   
Posterior reversible encephalopathy syndrome  1  1/60 (1.67%) 
Psychiatric disorders   
Delirium  1  2/60 (3.33%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/60 (1.67%) 
Vascular disorders   
Arteriosclerosis  1  1/60 (1.67%) 
Deep vein thrombosis  1  1/60 (1.67%) 
Hypotension  1  1/60 (1.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 21.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Talimogene Laherparepvec
Affected / at Risk (%)
Total   58/60 (96.67%) 
Gastrointestinal disorders   
Abdominal distension  1  4/60 (6.67%) 
Diarrhoea  1  13/60 (21.67%) 
Nausea  1  27/60 (45.00%) 
Vomiting  1  15/60 (25.00%) 
Stomatitis  1  5/60 (8.33%) 
General disorders   
Asthenia  1  7/60 (11.67%) 
Chest pain  1  3/60 (5.00%) 
Chills  1  39/60 (65.00%) 
Fatigue  1  34/60 (56.67%) 
Influenza like illness  1  12/60 (20.00%) 
Injection site erythema  1  3/60 (5.00%) 
Injection site pain  1  15/60 (25.00%) 
Injection site rash  1  3/60 (5.00%) 
Injection site reaction  1  6/60 (10.00%) 
Malaise  1  3/60 (5.00%) 
Oedema peripheral  1  5/60 (8.33%) 
Pain  1  15/60 (25.00%) 
Pyrexia  1  23/60 (38.33%) 
Infections and infestations   
Nasopharyngitis  1  7/60 (11.67%) 
Oral herpes  1  4/60 (6.67%) 
Cellulitis  1  4/60 (6.67%) 
Injury, poisoning and procedural complications   
Contusion  1  4/60 (6.67%) 
Fall  1  4/60 (6.67%) 
Investigations   
Body temperature increased  1  5/60 (8.33%) 
Metabolism and nutrition disorders   
Decreased appetite  1  4/60 (6.67%) 
Dehydration  1  3/60 (5.00%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  11/60 (18.33%) 
Back pain  1  8/60 (13.33%) 
Musculoskeletal pain  1  5/60 (8.33%) 
Myalgia  1  12/60 (20.00%) 
Pain in extremity  1  7/60 (11.67%) 
Neck pain  1  3/60 (5.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumour pain  1  6/60 (10.00%) 
Nervous system disorders   
Dizziness  1  7/60 (11.67%) 
Headache  1  27/60 (45.00%) 
Somnolence  1  4/60 (6.67%) 
Hypoaesthesia  1  3/60 (5.00%) 
Paraesthesia  1  4/60 (6.67%) 
Psychiatric disorders   
Depression  1  6/60 (10.00%) 
Anxiety  1  3/60 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  5/60 (8.33%) 
Dyspnoea  1  4/60 (6.67%) 
Nasal congestion  1  3/60 (5.00%) 
Oropharyngeal pain  1  3/60 (5.00%) 
Skin and subcutaneous tissue disorders   
Night sweats  1  6/60 (10.00%) 
Pruritus  1  6/60 (10.00%) 
Rash  1  12/60 (20.00%) 
Skin lesion  1  4/60 (6.67%) 
Erythema  1  3/60 (5.00%) 
Hyperhidrosis  1  3/60 (5.00%) 
Vascular disorders   
Hypotension  1  7/60 (11.67%) 
Hypertension  1  3/60 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 21.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
EMail: medinfo@amgen.com
Layout table for additonal information
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02014441     History of Changes
Other Study ID Numbers: 20120324
First Submitted: November 22, 2013
First Posted: December 18, 2013
Results First Submitted: December 15, 2016
Results First Posted: February 14, 2017
Last Update Posted: November 20, 2019