Trial Outcomes & Findings for Talimogene Laherparepvec With Pembrolizumab for Recurrent Metastatic Squamous Cell Carcinoma of the Head and Neck (MASTERKEY232 / KEYNOTE-137) (NCT NCT02626000)
NCT ID: NCT02626000
Last Updated: 2021-09-08
Results Overview
The following toxicities (graded per the Common Terminology Criteria for Adverse Events v 4.0) were considered DLTs if judged by the investigator to be related to either study drug: * grade 4 non-hematologic (non-laboratory) toxicity * ≥ grade 3 pneumonitis * grade 3 non-hematologic toxicity for \> 3 days with optimal supportive care * grade 3 fatigue was not classified as DLT, regardless of duration * any ≥ grade 3 non-hematologic laboratory value if: * medical intervention was required, * the abnormality led to hospitalization, or * the abnormality persisted at ≥ grade 3 for \> 1 week unless deemed not clinically important by investigator and sponsor * grade 3 or 4 febrile neutropenia * thrombocytopenia \< 25 x 10⁹/L associated with bleeding event requiring intervention * serious herpetic event: herpetic encephalitis, encephalomyelitis, or disseminated herpetic infection * grade 5 toxicity * other intolerable toxicity leading to permanent discontinuation of either study drug.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
First 6 weeks after the initial administration of talimogene laherparepvec and pembrolizumab in combination
Results posted on
2021-09-08
Participant Flow
This study was conducted at 19 centers in Australia, Canada, Europe, and the United States. This study was designed to be conducted in 2 parts (phase 1b and phase 3). A decision was made not to initiate the phase 3 part of the study.
Participant milestones
| Measure |
Talimogene Laherparepvec + Pembrolizumab
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 on day 1 followed by a dose of 10⁸ PFU/mL every 3 weeks (Q3W) thereafter. Pembrolizumab was administered by intravenous infusion at a dose of 200 mg Q3W.
Participants were treated until complete response, no injectable lesions, confirmed disease progression, intolerance of study treatment, 24 months from the date of the first dose of talimogene laherparepvec, or end of study, whichever occurred first.
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|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
| Measure |
Talimogene Laherparepvec + Pembrolizumab
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 on day 1 followed by a dose of 10⁸ PFU/mL every 3 weeks (Q3W) thereafter. Pembrolizumab was administered by intravenous infusion at a dose of 200 mg Q3W.
Participants were treated until complete response, no injectable lesions, confirmed disease progression, intolerance of study treatment, 24 months from the date of the first dose of talimogene laherparepvec, or end of study, whichever occurred first.
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|---|---|
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Overall Study
Decision by Sponsor
|
1
|
|
Overall Study
Death
|
29
|
Baseline Characteristics
Talimogene Laherparepvec With Pembrolizumab for Recurrent Metastatic Squamous Cell Carcinoma of the Head and Neck (MASTERKEY232 / KEYNOTE-137)
Baseline characteristics by cohort
| Measure |
Talimogene Laherparepvec + Pembrolizumab
n=36 Participants
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 on day 1 followed by a dose of 10⁸ PFU/mL every 3 weeks (Q3W) thereafter. Pembrolizumab was administered by intravenous infusion at a dose of 200 mg Q3W.
Participants were treated until complete response, no injectable lesions, confirmed disease progression, intolerance of study treatment, 24 months from the date of the first dose of talimogene laherparepvec, or end of study, whichever occurred first.
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|---|---|
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Age, Continuous
|
60.8 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Age, Customized
< 65 years
|
21 Participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black (or African American)
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
33 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 (Fully active)
|
9 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 (Restricted but ambulatory)
|
27 Participants
n=5 Participants
|
|
Herpes Simplex Virus Status
Negative
|
5 Participants
n=5 Participants
|
|
Herpes Simplex Virus Status
Positive
|
22 Participants
n=5 Participants
|
|
Herpes Simplex Virus Status
Unknown
|
9 Participants
n=5 Participants
|
|
Primary Tumor Site
Oropharynx
|
9 Participants
n=5 Participants
|
|
Primary Tumor Site
Larynx
|
4 Participants
n=5 Participants
|
|
Primary Tumor Site
Oral Cavity
|
20 Participants
n=5 Participants
|
|
Primary Tumor Site
Hypopharynx
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First 6 weeks after the initial administration of talimogene laherparepvec and pembrolizumab in combinationPopulation: The DLT analysis set included DLT-evaluable participants who had the opportunity to be on treatment for at least 6 weeks and had received at least 2 doses of talimogene laherparepvec and 2 doses of pembrolizumab in combination, or who had a DLT during the DLT evaluation period after at least 1 dose of both study drugs in combination.
The following toxicities (graded per the Common Terminology Criteria for Adverse Events v 4.0) were considered DLTs if judged by the investigator to be related to either study drug: * grade 4 non-hematologic (non-laboratory) toxicity * ≥ grade 3 pneumonitis * grade 3 non-hematologic toxicity for \> 3 days with optimal supportive care * grade 3 fatigue was not classified as DLT, regardless of duration * any ≥ grade 3 non-hematologic laboratory value if: * medical intervention was required, * the abnormality led to hospitalization, or * the abnormality persisted at ≥ grade 3 for \> 1 week unless deemed not clinically important by investigator and sponsor * grade 3 or 4 febrile neutropenia * thrombocytopenia \< 25 x 10⁹/L associated with bleeding event requiring intervention * serious herpetic event: herpetic encephalitis, encephalomyelitis, or disseminated herpetic infection * grade 5 toxicity * other intolerable toxicity leading to permanent discontinuation of either study drug.
Outcome measures
| Measure |
Talimogene Laherparepvec + Pembrolizumab
n=16 Participants
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 on day 1 followed by a dose of 10⁸ PFU/mL every 3 weeks (Q3W) thereafter. Pembrolizumab was administered by intravenous infusion at a dose of 200 mg Q3W.
Participants were treated until complete response, no injectable lesions, confirmed disease progression, intolerance of study treatment, 24 months from the date of the first dose of talimogene laherparepvec, or end of study, whichever occurred first.
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|---|---|
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Number of Participants With a Dose Limiting Toxicity (DLT)
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to the primary analysis data cutoff date of 02 November 2017; median (minimum, maximum) time on follow-up was 14.36 (1.4, 67.0) weeks.Population: The efficacy analysis set included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab, excluding participants with locoregionally advanced disease with a recurrence \< 3 months after prior platinum-containing curatively intended multimodal therapy.
Objective response rate was defined as the percentage of participants with a best overall response of complete response or partial response assessed by the investigator using immune-related Response Evaluation Criteria in Solid Tumors (irRECIST). Response was based on the size of tumors assessed by computed tomography (CT) or magnetic resonance imaging (MRI). Complete response (iCR): Disappearance of all lesions (whether measurable or not and whether baseline or new) and confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented was required. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (iPR): Decrease in tumor burden ≥ 30% relative to baseline. Confirmation by a consecutive assessment at least 4 weeks after first documentation required. Analyses are presented below for both the unconfirmed and confirmed results.
Outcome measures
| Measure |
Talimogene Laherparepvec + Pembrolizumab
n=32 Participants
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 on day 1 followed by a dose of 10⁸ PFU/mL every 3 weeks (Q3W) thereafter. Pembrolizumab was administered by intravenous infusion at a dose of 200 mg Q3W.
Participants were treated until complete response, no injectable lesions, confirmed disease progression, intolerance of study treatment, 24 months from the date of the first dose of talimogene laherparepvec, or end of study, whichever occurred first.
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|---|---|
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Objective Response Rate
Confirmed Response
|
9.4 percentage of participants
Interval 2.0 to 25.0
|
|
Objective Response Rate
Unconfirmed Response
|
15.6 percentage of participants
Interval 5.3 to 32.8
|
SECONDARY outcome
Timeframe: Up to the primary analysis data cutoff date of 02 November 2017; median (minimum, maximum) time on follow-up was 14.36 (1.4, 67.0) weeks.Population: The efficacy analysis set included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab, excluding participants with locoregionally advanced disease with a recurrence \< 3 months after prior platinum-containing curatively intended multimodal therapy.
Complete response rate (iCRR) was defined as the percentage of participants with a best overall response of complete response assessed by the investigator using immune-related Response Evaluation Criteria in Solid Tumors (irRECIST). Response was based on the size of tumors assessed by computed tomography (CT) or magnetic resonance imaging (MRI). Complete response (iCR): Disappearance of all lesions (whether measurable or not and whether baseline or new) and confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented was required. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Analyses are presented below for both the unconfirmed and confirmed results.
Outcome measures
| Measure |
Talimogene Laherparepvec + Pembrolizumab
n=32 Participants
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 on day 1 followed by a dose of 10⁸ PFU/mL every 3 weeks (Q3W) thereafter. Pembrolizumab was administered by intravenous infusion at a dose of 200 mg Q3W.
Participants were treated until complete response, no injectable lesions, confirmed disease progression, intolerance of study treatment, 24 months from the date of the first dose of talimogene laherparepvec, or end of study, whichever occurred first.
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|---|---|
|
Complete Response Rate
Confirmed Response
|
0.0 percentage of participants
Interval 0.0 to 10.9
|
|
Complete Response Rate
Unconfirmed Response
|
0.0 percentage of participants
Interval 0.0 to 10.9
|
SECONDARY outcome
Timeframe: Up to the primary analysis data cutoff date of 02 November 2017; median (minimum, maximum) time on follow-up was 14.36 (1.4, 67.0) weeks.Population: The efficacy analysis set included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab, excluding participants with locoregionally advanced disease with a recurrence \< 3 months after prior platinum-containing curatively intended multimodal therapy.
Best overall visit response of iCR, iPR, stable disease (iSD), progressive disease (iPD) or unevaluable (iUE) based on investigator assessment using irRECIST. iCR: Disappearance of all lesions (whether measurable or not and whether baseline or new). Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10 mm. iPR: Decrease in tumor size ≥ 30% relative to baseline. iPD: Increase in tumor size ≥ 20% and at least 5 mm absolute increase compared to nadir or qualitative worsening of non-target lesions or a new lesion. iSD: Neither sufficient shrinkage to qualify for iCR or iPR nor sufficient increase to qualify for iPD. iUE: Any baseline lesion which was not assessed or was unable to be evaluated leading to an inability to determine the status of that particular tumor. Not Done: Radiographic imaging was not performed to evaluate the response. iCR, iPR, and iPD required confirmation by a consecutive assessment at least 4 weeks after first documentation.
Outcome measures
| Measure |
Talimogene Laherparepvec + Pembrolizumab
n=32 Participants
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 on day 1 followed by a dose of 10⁸ PFU/mL every 3 weeks (Q3W) thereafter. Pembrolizumab was administered by intravenous infusion at a dose of 200 mg Q3W.
Participants were treated until complete response, no injectable lesions, confirmed disease progression, intolerance of study treatment, 24 months from the date of the first dose of talimogene laherparepvec, or end of study, whichever occurred first.
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|---|---|
|
Best Overall Confirmed Response
Complete Response (iCR)
|
0 Participants
|
|
Best Overall Confirmed Response
Partial Response (iPR)
|
3 Participants
|
|
Best Overall Confirmed Response
Stable Disease (iSD)
|
10 Participants
|
|
Best Overall Confirmed Response
Progressive Disease (iPD)
|
4 Participants
|
|
Best Overall Confirmed Response
Unevaluable (iUE)
|
6 Participants
|
|
Best Overall Confirmed Response
Not Done
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to the primary analysis data cutoff date of 02 November 2017; median (minimum, maximum) time on follow-up was 14.36 (1.4, 67.0) weeks.Population: Enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab, excluding participants with locoregionally advanced disease with a recurrence \< 3 months after prior platinum-containing curatively intended multimodal therapy, with a best response of iCR or iPR.
Duration of response (iDOR) per irRECIST was defined as the time from the date of an initial response of iCR or iPR that was subsequently confirmed to the earlier of a participant overall response of iPD or death. Participants who did not end their response at the time of analysis were censored at their last evaluable tumor assessment.
Outcome measures
| Measure |
Talimogene Laherparepvec + Pembrolizumab
n=3 Participants
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 on day 1 followed by a dose of 10⁸ PFU/mL every 3 weeks (Q3W) thereafter. Pembrolizumab was administered by intravenous infusion at a dose of 200 mg Q3W.
Participants were treated until complete response, no injectable lesions, confirmed disease progression, intolerance of study treatment, 24 months from the date of the first dose of talimogene laherparepvec, or end of study, whichever occurred first.
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|---|---|
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Duration of Confirmed Response
|
NA months
Could not be estimated due to the low number of events
|
SECONDARY outcome
Timeframe: Up to the primary analysis data cutoff date of 02 November 2017; median (minimum, maximum) time on follow-up was 14.36 (1.4, 67.0) weeks.Population: The efficacy analysis set included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab, excluding participants with locoregionally advanced disease with a recurrence \< 3 months after prior platinum-containing curatively intended multimodal therapy.
Disease control rate (iDCR) was defined as the percentage of participants with a best overall response of iCR or iPR or iSD assessed by the investigator using irRECIST. Complete response (iCR): Disappearance of all lesions (whether measurable or not and whether baseline or new) and confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented was required. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (iPR): Decrease in tumor burden ≥ 30% relative to baseline. Confirmation by a consecutive assessment at least 4 weeks after first documentation required. Stable disease (iSD): Neither sufficient shrinkage to qualify for iCR or iPR nor sufficient increase to qualify for iPD. Analyses are presented below for both the unconfirmed and confirmed results.
Outcome measures
| Measure |
Talimogene Laherparepvec + Pembrolizumab
n=32 Participants
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 on day 1 followed by a dose of 10⁸ PFU/mL every 3 weeks (Q3W) thereafter. Pembrolizumab was administered by intravenous infusion at a dose of 200 mg Q3W.
Participants were treated until complete response, no injectable lesions, confirmed disease progression, intolerance of study treatment, 24 months from the date of the first dose of talimogene laherparepvec, or end of study, whichever occurred first.
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|---|---|
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Disease Control Rate
Confirmed Response
|
40.6 percentage of participants
Interval 23.7 to 59.4
|
|
Disease Control Rate
Unconfirmed Response
|
40.6 percentage of participants
Interval 23.7 to 59.4
|
SECONDARY outcome
Timeframe: Up to the primary analysis data cutoff date of 02 November 2017; median (minimum, maximum) time on follow-up was 14.36 (1.4, 67.0) weeks.Population: The efficacy analysis set included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab, excluding participants with locoregionally advanced disease with a recurrence \< 3 months after prior platinum-containing curatively intended multimodal therapy.
Progression-free survival (iPFS) per irRECIST was defined as the interval from first dose to the earlier of a participant overall response of iPD or death from any cause; otherwise, iPFS was censored at the last evaluable tumor assessment. The initial date of an iPD that was consecutively confirmed was used.
Outcome measures
| Measure |
Talimogene Laherparepvec + Pembrolizumab
n=32 Participants
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 on day 1 followed by a dose of 10⁸ PFU/mL every 3 weeks (Q3W) thereafter. Pembrolizumab was administered by intravenous infusion at a dose of 200 mg Q3W.
Participants were treated until complete response, no injectable lesions, confirmed disease progression, intolerance of study treatment, 24 months from the date of the first dose of talimogene laherparepvec, or end of study, whichever occurred first.
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|---|---|
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Progression Free Survival
|
3.0 months
Interval 2.0 to 5.8
|
SECONDARY outcome
Timeframe: Up to the primary analysis data cutoff date of 02 November 2017; median (minimum, maximum) time on follow-up was 14.36 (1.4, 67.0) weeks.Population: The efficacy analysis set included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab, excluding participants with locoregionally advanced disease with a recurrence \< 3 months after prior platinum-containing curatively intended multimodal therapy.
Overall survival (OS) was defined as the interval from first dose to the event of death from any cause; otherwise, OS was censored at the date the participant was last known to be alive.
Outcome measures
| Measure |
Talimogene Laherparepvec + Pembrolizumab
n=32 Participants
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 on day 1 followed by a dose of 10⁸ PFU/mL every 3 weeks (Q3W) thereafter. Pembrolizumab was administered by intravenous infusion at a dose of 200 mg Q3W.
Participants were treated until complete response, no injectable lesions, confirmed disease progression, intolerance of study treatment, 24 months from the date of the first dose of talimogene laherparepvec, or end of study, whichever occurred first.
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|---|---|
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Overall Survival
|
5.2 months
Interval 2.1 to 11.4
|
SECONDARY outcome
Timeframe: From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.Population: All enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
The severity of adverse events was assessed by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, and based on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. A serious adverse event is an AE that met at least 1 of the following serious criteria: * fatal * life threatening * required in-patient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event.
Outcome measures
| Measure |
Talimogene Laherparepvec + Pembrolizumab
n=36 Participants
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 on day 1 followed by a dose of 10⁸ PFU/mL every 3 weeks (Q3W) thereafter. Pembrolizumab was administered by intravenous infusion at a dose of 200 mg Q3W.
Participants were treated until complete response, no injectable lesions, confirmed disease progression, intolerance of study treatment, 24 months from the date of the first dose of talimogene laherparepvec, or end of study, whichever occurred first.
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|---|---|
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Number of Participants With Adverse Events
All treatment-emergent adverse events
|
36 Participants
|
|
Number of Participants With Adverse Events
Treatment-emergent adverse events grade ≥ 2
|
36 Participants
|
|
Number of Participants With Adverse Events
Treatment-emergent adverse events grade ≥ 3
|
26 Participants
|
|
Number of Participants With Adverse Events
Treatment-emergent adverse events grade ≥ 4
|
11 Participants
|
|
Number of Participants With Adverse Events
Serious adverse events
|
26 Participants
|
|
Number of Participants With Adverse Events
AE leading to discontinuation of T-VEC
|
6 Participants
|
|
Number of Participants With Adverse Events
AE leading to discontinuation of pembrolizumab
|
6 Participants
|
|
Number of Participants With Adverse Events
Fatal adverse events
|
7 Participants
|
|
Number of Participants With Adverse Events
Talimogene laherparepvec-related AEs
|
21 Participants
|
|
Number of Participants With Adverse Events
Pembrolizumab-related AEs
|
21 Participants
|
Adverse Events
Talimogene Laherparepvec + Pembrolizumab
Serious events: 26 serious events
Other events: 33 other events
Deaths: 29 deaths
Serious adverse events
| Measure |
Talimogene Laherparepvec + Pembrolizumab
n=36 participants at risk
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 on day 1 followed by a dose of 10⁸ PFU/mL every 3 weeks (Q3W) thereafter. Pembrolizumab was administered by intravenous infusion at a dose of 200 mg Q3W.
Participants were treated until complete response, no injectable lesions, confirmed disease progression, intolerance of study treatment, 24 months from the date of the first dose of talimogene laherparepvec, or end of study, whichever occurred first.
|
|---|---|
|
Gastrointestinal disorders
Dysphagia
|
5.6%
2/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Odynophagia
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
General physical health deterioration
|
5.6%
2/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Mucosal haemorrhage
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
5.6%
2/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatitis
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Localised infection
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
5.6%
2/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Staphylococcal infection
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Tracheitis
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Wound infection
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Tracheal obstruction
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Tracheostomy malfunction
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.6%
2/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of head and neck
|
5.6%
2/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Somnolence
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Delirium
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
5.6%
2/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Arterial haemorrhage
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Wound infection bacterial
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Euglycaemic diabetic ketoacidosis
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral venous sinus thrombosis
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
2.8%
1/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Talimogene Laherparepvec + Pembrolizumab
n=36 participants at risk
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 on day 1 followed by a dose of 10⁸ PFU/mL every 3 weeks (Q3W) thereafter. Pembrolizumab was administered by intravenous infusion at a dose of 200 mg Q3W.
Participants were treated until complete response, no injectable lesions, confirmed disease progression, intolerance of study treatment, 24 months from the date of the first dose of talimogene laherparepvec, or end of study, whichever occurred first.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
6/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
8.3%
3/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
8.3%
3/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
9/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.9%
5/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
22.2%
8/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
19.4%
7/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Odynophagia
|
8.3%
3/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oral pain
|
11.1%
4/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
5.6%
2/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
13.9%
5/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
13.9%
5/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Face oedema
|
5.6%
2/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
27.8%
10/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Influenza like illness
|
13.9%
5/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Injection site pain
|
8.3%
3/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
33.3%
12/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
11.1%
4/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
5.6%
2/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Rhinitis
|
5.6%
2/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Skin infection
|
8.3%
3/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Body temperature increased
|
8.3%
3/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.9%
5/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.6%
2/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.3%
3/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.1%
4/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
2/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
8.3%
3/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
16.7%
6/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
5.6%
2/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
11.1%
4/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.4%
7/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
12/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.6%
2/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
5.6%
2/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.6%
2/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
2/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
2/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
5.6%
2/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
5.6%
2/36 • From first dose of study drug to 30 days after last dose; the median (range) duration of treatment was 5.6 (0.1 to 75.3) weeks for talimogene laherparepvec and 6.1 (0.1, 105.3) weeks for pembrolizumab.
Serious adverse event and other adverse events are reported for all participants who received at least one dose of study drug.
|
Additional Information
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