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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001906-61 | EudraCT Number |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This is a phase 2, open-label, single-arm, multicenter clinical trial designed to evaluate the efficacy and safety of talimogene laherparepvec in combination with pembrolizumab following disease progression on prior anti-programmed cell death protein (anti-PD-1) therapy in unresectable/metastatic melanoma (stage IIIB-IVM1d) or prior anti-PD-1 therapy in the adjuvant setting. Subjects will be treated with talimogene laherparepvec and pembrolizumab until confirmed complete response, disappearance of all injectable lesions, documented confirmed disease progression per modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST), intolerance of study treatment, or 102 weeks from the first dose of talimogene laherparepvec and/or pembrolizumab, whichever occurs first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance | Experimental | Includes participants who received anti-PD1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression. Participants will receive talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 plaque-forming units (PFU)/mL on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL will be administered every 3 weeks for up to 35 cycles in total. Participants will also receive pembrolizumab at a dose of 200 mg every 3 weeks for up to 35 cycles. |
|
| Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance | Experimental | Includes participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants will receive talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 plaque-forming units (PFU)/mL on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL will be administered every 3 weeks for up to 35 cycles in total. Participants will also receive pembrolizumab at a dose of 200 mg every 3 weeks for up to 35 cycles. |
|
| Cohort 3 - Adjuvant Setting -Disease Free Interval < 6 months | Experimental | Includes participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of < 6 months after starting the adjuvant anti-PD-1 therapy. Participants will receive talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 plaque-forming units (PFU)/mL on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL will be administered every 3 weeks for up to 35 cycles in total. Participants will also receive pembrolizumab at a dose of 200 mg every 3 weeks for up to 35 cycles. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talimogene laherparepvec | Drug | Intralesional injection into injectable cutaneous, subcutaneous and nodal legions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Per Modified RECIST v1.1 | ORR was defined as the incidence of a best overall response (BOR) of complete response (CR) or partial response (PR) per modified RECIST v1.1:
| Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate (CRR) Per Modified RECIST v1.1 | CRR was defined as the incidence of a BOR of CR per modified RECIST v1.1:
Confirmation of CR was not required per modified RECIST v1.1. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sansum Clinic | Santa Barbara | California | 93105 | United States | ||
| Medical Oncology Hematology Consultants Helen F Graham Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38870745 | Background | Robert C, Gastman B, Gogas H, Rutkowski P, Long GV, Chaney MF, Joshi H, Lin YL, Snyder W, Chesney JA. Open-label, phase II study of talimogene laherparepvec plus pembrolizumab for the treatment of advanced melanoma that progressed on prior anti-PD-1 therapy: MASTERKEY-115. Eur J Cancer. 2024 Aug;207:114120. doi: 10.1016/j.ejca.2024.114120. Epub 2024 May 15. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
Participants must have received prior anti-programmed cell death protein (anti-PD-1) therapy for at least 2 to 3 consecutive cycles within an 8-week period and have disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. The anti-PD-1 therapy must have been the immediate prior line of therapy before enrollment, and participants with disease progression on more than 1 line of anti-PD-1 therapy were not eligible.
72 participants were enrolled at 28 centers in Australia, Canada, France, Germany, Greece, Italy, the Netherlands, Poland, Spain and the United States from 22 January 2020 to 26 February 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance | Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 plaque-forming units (PFU)/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an intravenous (IV) infusion every 3 weeks for up to 35 cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 9, 2021 | Aug 15, 2022 |
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|
| Cohort 4 - Adjuvant Setting -Disease Free Interval ≥ 6 months | Experimental | Includes participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants will receive talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 plaque-forming units (PFU)/mL on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL will be administered every 3 weeks for up to 35 cycles in total. Participants will also receive pembrolizumab at a dose of 200 mg every 3 weeks for up to 35 cycles. |
|
| Pembrolizumab | Drug | Intravenous (IV) infusion. |
|
| Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| Complete Response Rate (iCRR) Per Modified Immune-related Response Criteria (irRC) RECIST v1.1 | iCRR was defined as the incidence of a best overall response (iBOR) of a complete response (iCR) per modified irRC-RECIST:
Confirmation of iCR was required per modified irRC-RECIST. | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| BOR Per Modified RECIST v1.1 | BOR was the best overall visit response up to & including the first overall visit response of PD:
Confirmation of CR, PR & PD were not required per modified RECIST 1.1. | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| Best Overall Response (iBOR) Per Modified irRC-RECIST | iBOR was defined as the best overall visit response up to and including the first overall visit response of progressive disease (iPD) per modified irRC-RECIST:
Confirmation of iCR, iPR and iPD was required per modified irRC-RECIST. | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| Durable Response Rate (DRR) Per Modified RECIST v1.1 | DRR was defined as the percentage of participants with a CR or PR per modified RECIST v1.1 with a duration of response (DOR) ≥ 6 months. One month was calculated based on 365.25 days per year.
Confirmation of CR and PR were not required per modified RECIST v1.1. | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| Durable Response Rate (iDRR) Per Modified irRC-RECIST | iDRR was defined as the percentage of participants with an iCR or iPR per modified irRC-RECIST with a duration of response (iDOR) ≥ 6 months. One month was calculated based on 365.25 days per year.
Confirmation of iCR and iPR were required per modified irRC-RECIST. | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| DOR Per Modified RECIST v1.1 | DOR was defined as the time from the date of an initial response of CR or PR to the earlier of PD/death. Participants who had not ended their response at the time of analysis were censored at their last evaluable tumor assessment date before start of first subsequent anticancer therapy. One month was calculated based on 365.25 days per year.
Confirmation of CR, PR and PD were not required per modified RECIST v1.1. | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| iDOR Per Modified irRC-RECIST | iDOR was defined as the time from the date of an initial response that is subsequently confirmed to the earlier of iPD per modified irRC-RECIST. Participants who had not ended their response at the time of analysis were censored at their last evaluable tumor assessment date before start of first subsequent anticancer therapy. One month was calculated based on 365.25 days per year.
| Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| Disease Control Rate (DCR) Per Modified RECIST v1.1 | DCR per modified RECIST v1.1 was defined as the incidence of a BOR of CR, PR or SD.
Confirmation of CR and PR were not required per modified RECIST v1.1. | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| Disease Control Rate (iDCR) Per Modified irRC-RECIST | iDCR per modified irRC-RECIST was defined as the incidence of an iBOR of iCR, iPR or iSD.
Confirmation of iCR and iPR were required per modified irRC-RECIST. | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| Objective Response Rate (iORR) Per Modified irRC-RECIST | iORR was defined as the incidence of an iBOR of iCR or iPR per modified irRC-RECIST
Confirmation of iCR and iPR were required per modified irRC-RECIST. | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| Progression Free Survival (PFS) Per Modified RECIST v1.1 | PFS per modified RECIST 1.1 was defined as the interval from first dose to the earlier event of PD or death from any cause. Participants without an event were censored at their last evaluable post-baseline tumor assessment if available, otherwise were censored on study Day 1. One month was calculated based on 365.25 days per year. - PD: At least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. Unequivocal progression of existing non-target lesions. | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| Progression Free Survival (iPFS) Per Modified irRC-RECIST | iPFS per modified irRC-RECIST was defined as the interval from first dose to the earlier event of iPD or death from any cause. Participants without an event were censored at their last evaluable post-baseline tumor assessment if available, otherwise were censored on study Day 1. One month was calculated based on 365.25 days per year. - iPD: Increase in tumor burden ≥ 20% and at least 5 mm absolute increase. | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| Overall Survival (OS) | OS was defined as the interval from first dose to death from any cause. Participants without an event were censored at the last date known to be alive. One month was calculated based on 365.25 days per year. | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | Evaluation of TEAEs included the number of participants with at least 1:
Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. A CTCAE grade ≥ 3 was determined using the CTCAE grading systems based on CTCAE version 5.0 per the below definitions:
Abnormal laboratory tests were also recorded as TEAEs. | Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks. |
| Time to First Subsequent Anti-cancer Therapy | Time to first subsequent anti-cancer therapy was defined as the time from enrollment to the start of subsequent anticancer therapy. Participants who did not start subsequent anticancer therapy were censored as the last known to be alive date. One month was calculated based on 365.25 days per year. | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| Newark |
| Delaware |
| 19713 |
| United States |
| University of Florida Health Cancer Center at Orlando Health | Orlando | Florida | 32806 | United States |
| University of Louisville James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | United States |
| Allina Health Systems dba Virginia Piper Cancer Institute | Fridley | Minnesota | 55432 | United States |
| New York Oncology Hematology, PC | Albany | New York | 12208 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Texas Oncology Austin Central | Austin | Texas | 78731 | United States |
| Baylor Scott and White Research Institute | Dallas | Texas | 75246 | United States |
| United States Oncology Regulatory Affairs Corporate Office | The Woodlands | Texas | 77380 | United States |
| Melanoma Institute Australia | North Sydney | New South Wales | 2060 | Australia |
| Tasman Oncology Research | Southport | Queensland | 4215 | Australia |
| The Queen Elizabeth Hospital | Woodville South | South Australia | 5011 | Australia |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | 3000 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| CHU de Quebec-Universite Laval | Québec | Quebec | G1R 2J6 | Canada |
| Centre Hospitalier Universitaire de Bordeaux - Hôpital Saint André | Bordeaux | 33075 | France |
| Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon | Grenoble | 38043 | France |
| Centre Hospitalier Universitaire de Nantes, Hôpital Hôtel Dieu | Nantes | 44093 | France |
| Hopital Saint Louis | Paris | 75010 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| Gustave Roussy | Villejuif | 94805 | France |
| Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden | Dresden | 01307 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Universitätsklinikum Regensburg | Regensburg | 93053 | Germany |
| Universitätsklinikum Tübingen | Tübingen | 72076 | Germany |
| General Hospital of Athens Laiko | Athens | 11527 | Greece |
| University Hospital of Ioannina | Ioannina | 45500 | Greece |
| Bioclinic of Thessaloniki | Thessaloniki | 546 22 | Greece |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII | Bergamo | 24127 | Italy |
| IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" | Meldola FC | 47014 | Italy |
| IRCCS Istituto Europeo di Oncologia | Milan | 20141 | Italy |
| Nederlands Kanker Instituut, Antoni van Leeuwenhoekziekenhuis | Amsterdam | 1066 CX | Netherlands |
| Erasmus Medisch Centrum | Rotterdam | 3015 GD | Netherlands |
| Uniwersyteckie Centrum Kliniczne Centrum Medycyny Nieinwazyjnej | Gdansk | 80-214 | Poland |
| Szpital Kliniczny im Heliodora Swiecickiego Uniwersytetu Medycznego im Karola Marcinkowskiego w Pozn | Poznan | 60-780 | Poland |
| Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie â€" Panstwowy Instytut Badawczy | Warsaw | 02-781 | Poland |
| Hospital Clinico Universitario Virgen de la Victoria | Málaga | AndalucÃ-a | 29010 | Spain |
| Onkologikoa | Donostia / San Sebastian | PaÃ-s Vasco | 20014 | Spain |
| Hospital Universitari Vall d Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Madrid Sanchinarro | Madrid | 28050 | Spain |
| Guys Hospital | London | SE1 9RT | United Kingdom |
| Royal Marsden Hospital | London | SW3 6JJ | United Kingdom |
| FG001 | Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance | Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| FG002 | Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months | Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of < 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| FG003 | Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months | Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| Received Talimogene Laherparepvec |
|
| Received Pembrolizumab |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set: All enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance | Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 plaque-forming units (PFU)/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an intravenous (IV) infusion every 3 weeks for up to 35 cycles. |
| BG001 | Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance | Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| BG002 | Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months | Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of < 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| BG003 | Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months | Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) Per Modified RECIST v1.1 | ORR was defined as the incidence of a best overall response (BOR) of complete response (CR) or partial response (PR) per modified RECIST v1.1:
| Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Complete Response Rate (CRR) Per Modified RECIST v1.1 | CRR was defined as the incidence of a BOR of CR per modified RECIST v1.1:
Confirmation of CR was not required per modified RECIST v1.1. | Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Complete Response Rate (iCRR) Per Modified Immune-related Response Criteria (irRC) RECIST v1.1 | iCRR was defined as the incidence of a best overall response (iBOR) of a complete response (iCR) per modified irRC-RECIST:
Confirmation of iCR was required per modified irRC-RECIST. | Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | BOR Per Modified RECIST v1.1 | BOR was the best overall visit response up to & including the first overall visit response of PD:
Confirmation of CR, PR & PD were not required per modified RECIST 1.1. | Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination. | Posted | Count of Participants | Participants | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Best Overall Response (iBOR) Per Modified irRC-RECIST | iBOR was defined as the best overall visit response up to and including the first overall visit response of progressive disease (iPD) per modified irRC-RECIST:
Confirmation of iCR, iPR and iPD was required per modified irRC-RECIST. | Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination. | Posted | Count of Participants | Participants | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Durable Response Rate (DRR) Per Modified RECIST v1.1 | DRR was defined as the percentage of participants with a CR or PR per modified RECIST v1.1 with a duration of response (DOR) ≥ 6 months. One month was calculated based on 365.25 days per year.
Confirmation of CR and PR were not required per modified RECIST v1.1. | Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Durable Response Rate (iDRR) Per Modified irRC-RECIST | iDRR was defined as the percentage of participants with an iCR or iPR per modified irRC-RECIST with a duration of response (iDOR) ≥ 6 months. One month was calculated based on 365.25 days per year.
Confirmation of iCR and iPR were required per modified irRC-RECIST. | Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | DOR Per Modified RECIST v1.1 | DOR was defined as the time from the date of an initial response of CR or PR to the earlier of PD/death. Participants who had not ended their response at the time of analysis were censored at their last evaluable tumor assessment date before start of first subsequent anticancer therapy. One month was calculated based on 365.25 days per year.
Confirmation of CR, PR and PD were not required per modified RECIST v1.1. | Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination. Only participants who had an initial response of CR or PR were included. | Posted | Median | 95% Confidence Interval | Months | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | iDOR Per Modified irRC-RECIST | iDOR was defined as the time from the date of an initial response that is subsequently confirmed to the earlier of iPD per modified irRC-RECIST. Participants who had not ended their response at the time of analysis were censored at their last evaluable tumor assessment date before start of first subsequent anticancer therapy. One month was calculated based on 365.25 days per year.
| Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination. Only participants who had an initial response of iCR or iPR were included. | Posted | Median | 95% Confidence Interval | Months | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) Per Modified RECIST v1.1 | DCR per modified RECIST v1.1 was defined as the incidence of a BOR of CR, PR or SD.
Confirmation of CR and PR were not required per modified RECIST v1.1. | Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (iDCR) Per Modified irRC-RECIST | iDCR per modified irRC-RECIST was defined as the incidence of an iBOR of iCR, iPR or iSD.
Confirmation of iCR and iPR were required per modified irRC-RECIST. | Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (iORR) Per Modified irRC-RECIST | iORR was defined as the incidence of an iBOR of iCR or iPR per modified irRC-RECIST
Confirmation of iCR and iPR were required per modified irRC-RECIST. | Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) Per Modified RECIST v1.1 | PFS per modified RECIST 1.1 was defined as the interval from first dose to the earlier event of PD or death from any cause. Participants without an event were censored at their last evaluable post-baseline tumor assessment if available, otherwise were censored on study Day 1. One month was calculated based on 365.25 days per year. - PD: At least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. Unequivocal progression of existing non-target lesions. | Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination. | Posted | Median | 95% Confidence Interval | Months | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (iPFS) Per Modified irRC-RECIST | iPFS per modified irRC-RECIST was defined as the interval from first dose to the earlier event of iPD or death from any cause. Participants without an event were censored at their last evaluable post-baseline tumor assessment if available, otherwise were censored on study Day 1. One month was calculated based on 365.25 days per year. - iPD: Increase in tumor burden ≥ 20% and at least 5 mm absolute increase. | Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination. | Posted | Median | 95% Confidence Interval | Months | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the interval from first dose to death from any cause. Participants without an event were censored at the last date known to be alive. One month was calculated based on 365.25 days per year. | Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination. | Posted | Median | 95% Confidence Interval | Months | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | Evaluation of TEAEs included the number of participants with at least 1:
Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. A CTCAE grade ≥ 3 was determined using the CTCAE grading systems based on CTCAE version 5.0 per the below definitions:
Abnormal laboratory tests were also recorded as TEAEs. | Safety Analysis Set: All enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab. | Posted | Count of Participants | Participants | Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks. |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Time to First Subsequent Anti-cancer Therapy | Time to first subsequent anti-cancer therapy was defined as the time from enrollment to the start of subsequent anticancer therapy. Participants who did not start subsequent anticancer therapy were censored as the last known to be alive date. One month was calculated based on 365.25 days per year. | Full Analysis Set: Includes all enrolled participants who have received at least 1 dose of talimogene laherparepvec and 1 dose of pembrolizumab in combination. | Posted | Median | 95% Confidence Interval | Months | Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months |
|
Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
All-cause mortality was collected for all enrolled participants. Serious TEAEs and non-serious TEAEs were collected for the safety analysis set which included all enrolled participants who received at least 1 dose of talimogene laherparepvec or pembrolizumab.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance | Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. | 17 | 27 | 12 | 26 | 20 | 26 |
| EG001 | Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance | Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. | 12 | 15 | 7 | 15 | 15 | 15 |
| EG002 | Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months | Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of < 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. | 4 | 15 | 4 | 15 | 15 | 15 |
| EG003 | Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months | Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. | 7 | 15 | 7 | 15 | 14 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Adrenocortical insufficiency acute | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Renal disorder | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anaemia vitamin B12 deficiency | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Ear discomfort | Ear and labyrinth disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Conjunctival suffusion | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Retinal disorder | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Xerophthalmia | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anal haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Injection site extravasation | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Injection site inflammation | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Injection site oedema | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Injection site paraesthesia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hepatic cytolysis | Hepatobiliary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Contrast media allergy | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Cellulitis orbital | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Genital herpes simplex | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Herpes simplex reactivation | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Accident at home | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rheumatic disorder | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Urethral dilatation | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hair colour changes | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Scab | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Skin hyperplasia | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Umbilical discharge | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Vitiligo | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Skin neoplasm excision | Surgical and medical procedures | MedDRA 26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Change of bowel habit | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Xerosis | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Dermatophytosis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Immunisation reaction | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Skin wound | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Benign salivary gland neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Tumour fistulisation | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Penile dermatitis | Reproductive system and breast disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Lichen planus | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 12, 2021 | Aug 15, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000629782 | talimogene laherparepvec |
| C582435 | pembrolizumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black (or African American) |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Other |
|
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG002 | Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months | Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of < 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG003 | Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months | Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
|
|
| Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance |
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG002 | Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months | Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of < 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG003 | Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months | Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
|
|
| OG001 | Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance | Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG002 | Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months | Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of < 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG003 | Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months | Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
|
|
| OG001 | Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance | Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG002 | Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months | Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of < 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG003 | Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months | Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
|
|
| OG001 | Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance | Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG002 | Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months | Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of < 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG003 | Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months | Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
|
|
| OG001 | Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance | Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG002 | Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months | Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of < 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG003 | Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months | Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
|
|
| OG001 | Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance | Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG002 | Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months | Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of < 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG003 | Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months | Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
|
|
| OG001 | Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance | Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG002 | Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months | Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of < 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG003 | Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months | Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
|
|
| OG001 | Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance | Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG002 | Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months | Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of < 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG003 | Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months | Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
|
|
| OG001 |
| Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance |
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG002 | Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months | Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of < 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG003 | Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months | Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
|
|
Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG002 | Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months | Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of < 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG003 | Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months | Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
|
|
| OG001 | Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance | Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG002 | Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months | Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of < 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG003 | Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months | Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
|
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Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG002 | Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months | Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of < 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG003 | Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months | Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
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| OG002 | Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months | Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of < 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG003 | Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months | Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
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| OG001 | Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance | Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG002 | Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months | Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of < 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG003 | Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months | Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
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Included participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy.
Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles.
| OG002 | Cohort 3 - Adjuvant Setting - Disease Free Interval < 6 Months | Included participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of < 6 months after starting the adjuvant anti-PD-1 therapy. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
| OG003 | Cohort 4 - Adjuvant Setting - Disease Free Interval ≥ 6 Months | Included participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor. Participants received talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous and nodal legions on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL were administered every 3 weeks for up to 35 cycles in total. Participants also received pembrolizumab at a dose of 200 mg as an IV infusion every 3 weeks for up to 35 cycles. |
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