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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005386-67 | EudraCT Number |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This is a phase 1b/2, multicenter, open-label, basket trial to evaluate the safety of talimogene laherparepvec injected intrahepatically into liver tumors alone and in combination with systemic intravenous (IV) administration of pembrolizumab, in subjects with non-hepatocellular carcinoma (HCC) liver metastases from breast adenocarcinoma (BC), colorectal adenocarcinoma (CRC), gastroesophageal cancer (GEC), melanoma, non-small cell lung cancer (NSCLC), clear cell renal cell carcinoma (RCC) in Part 1 Group A, and subjects with HCC with and without viral hepatitis in Part 1 Group B (viral hepatitis is only applicable in combination setting), and to evaluate the efficacy and safety of intratumoral talimogene laherparepvec in combination with systemic pembrolizumab in subjects with advanced triple negative breast cancer (TNBC), hormone receptor positive breast cancer, CRC, cutaneous squamous cell carcinoma (CSCC), and basal cell carcinoma (BCC) in Part 2 Group A and subjects with HCC with and without viral hepatitis in Part 2 Group B. The objective of Part 1 is to evaluate the safety of intrahepatic injection of talimogene laherparepvec into liver tumors alone and in combination with systemically administered pembrolizumab for the non-HCC (Group A) and HCC (Group B) cohorts separately. Part 2 consists of 2-stage design to evaluate the efficacy and safety of talimogene laherparepvec in combination with systemic pembrolizumab. Efficacy and safety will be evaluated in each of the five non-HCC tumor types from Group A separately. Similarly, the efficacy and safety of the combination treatment will be determined for Group B HCC subjects. As of Protocol Amendment 6 (dated 26 October 2021), intrahepatic injections of talimogene laherparepvec and liver biopsies are no longer performed in this study. Enrollment for this study has stopped.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase Ib/II Talimogene Laherparepvec | Experimental | Talimogene Laherparepvec |
|
| Phase Ib/II Talimogene Laherparepvec + Pembrolizumab | Experimental | Combination treatment of Talimogene Laherparepvec and Pembrolizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talimogene Laherparepvec | Drug | Talimogene laherparepvec (T-VEC) administered by intralesional injection into liver tumors, with ultrasound/computed tomography (US/CT) guidance. Part 1: initial dose of T-VEC is 10^6 plaque forming unit (PFU)/mL up to 4mL in Cohorts 1 & 2, up to 8mL in Cohorts 3 & 4 of the Group A & Group B. The 1st cycle of T-VEC will be 21 (+3) days (from the 1st dose at 10^6 PFU/mL to the 2nd dose at 10^7 or 10^8 PFU/mL). Subsequent cycles of T-VEC will be 21 (±3) days. Max. volume of T-VEC administered at any dose is 4mL (Cohorts 1, 2, 5, and 6) or 8mL (Cohorts 3 & 4) for any individual lesion or for all lesions combined. Part 2: Initial dose of T-VEC is 10^6 PFU/mL followed by subsequent T-VEC doses at a concentration of 10^8 PFU/mL. T-VEC volume is up to 8mL based on the size of the inejected lesions. NOTE: as of Protocol Amendment 6 [dated 26 October 2021], intrahepatic injections of talimogene laherparepvec and liver biopsies are no longer performed in this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | All toxicities were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03:
The occurrence of specific pre-defined toxicities during the DLT evaluation period were considered a DLT if judged by the investigator to be related to talimogene laherparepvec and/or pembrolizumab. All Grade 5 toxicities, intolerable toxicities that lead to permanent discontinuation of talimogene laherparepvec and/or pembrolizumab and Grade 3 or higher AEs related to talimogene laherparepvec and/or pembrolizumab that resulted in a study treatment delay by > 2 weeks were considered DLTs. | Cycle 1 and Cycle 2: Day 1 to Day 21 |
| Part 2 Only: Objective Response Rate (ORR) Per Modified Immune-related Response Criteria Simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST). | ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) per modified irRC-RECIST.
| Up to 154 weeks |
| Part 2 Only: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | A TEAE was defined as an event that emerged during treatment, having been absent pretreatment, or worsened relative to the pretreatment state. A treatment-related TEAE was defined as a TEAE that was suspected to be related to the study treatment. | Day 1 to 30 days post-last dose of talimogene laherparepvec or pembrolizumab, whichever is later. The maximum duration of talimogene laherparepvec treatment was 102.4 weeks and pembrolizumab treatment was 109.3 weeks in Part 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 Only: ORR Per Modified irRC-RECIST | ORR was defined as the percentage of participants with a best overall response of CR or PR per modified irRC-RECIST.
|
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Summary of Subject Eligibility Criteria:
Key Inclusion Criteria:
Subjects must be age ≥ 18 years at the time of informed consent. Subjects must have histologically or cytologically confirmed disease.
Part 1 is restricted to BC, CRC, GEC, melanoma, NSCLC, or RCC with liver metastases or HCC.
Part 2 Group A is restricted to advanced hormone receptor positive BC, CRC, TNBC, CSCC, and BCC with or without liver metastases.
Part 2 Group B is restricted to HCC (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible).
For HCC subjects with a diagnosis of hepatitis B, they must be on antiviral therapy for at least 4 weeks prior to enrollment and hepatitis B virus (HBV) viral load by real-time polymerase chain reaction (qPCR) must be < 100 IU/mL. HCC subjects with past or ongoing hepatitis C infection must have completed treatment for hepatitis C at least 1 month prior to study enrollment and hepatitis C viral load must be undetectable; subjects with hepatitis B and C must fulfill the eligibility criteria for hepatitis B and hepatitis C. Subjects with unresectable locally recurrent TNBC are eligible.
Non-HCC subjects must have received at least 1 prior standard of care systemic anti-cancer therapy for their locally advanced or metastatic disease. For the combination cohorts (Cohorts 5 and 6 in Part 1) and Part 2, subjects with melanoma CSCC or NSCLC do not need to have received prior therapy. In Part 1, subjects must have measurable liver tumors and liver tumors that are suitable for injection. In Part 2, subjects must have measurable disease and cutaneous, subcutaneous, lymph node, or liver tumors suitable for injection. NOTE: as of Protocol Amendment 6 [dated 26 October 2021], intrahepatic injections of talimogene laherparepvec and liver biopsies are no longer performed in this study, enrollment for this study has stopped. Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1, and life expectancy should be approximately 5 months or more. Adequate hematological, renal, hepatic, and coagulation function is required. Liver function tests may be mildly abnormal but within the parameters. Child-Pugh score must be A.
Key Exclusion Criteria:
Subjects must not be candidates for surgery or locoregional therapy with curative intent or planned systemic anti-cancer therapy, with the exception of immunotherapy in the combination cohorts (Cohorts 5 and 6 in Part 1 and all subjects in Part 2). Liver tumors must not be estimated to invade approximately more than one-third of the liver. Liver tumor-directed therapy, hepatic surgery or major surgery, antibody-based therapy, or immunotherapy must not have been performed < 28 days, chemotherapy < 21 days, and targeted small molecule therapy or hormonal therapy < 14 days prior to enrollment. Subjects must either (1) have no central nervous system (CNS) metastasis, or carcinomatous meningitis, or (2) if CNS metastasis is present, must have stable treated cerebral metastases. Subjects must not have symptomatic auto-immune disease or be symptomatically immunosuppressed. They must not have a history of solid organ transplantation. For non-HCC, there must not be acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. For HCC with prior hepatitis B and/or C infection, HBV and/or HCV viral load by qPCR must be undetectable, and they must not have had recent treatment within 12 weeks for HBV or HCV with certain antiviral medications in Part 1 Group B cohorts 1-5 and 6a, and Part 2 Group B HCC without viral hepatitis. For all patients in Part 1 and for patients in Part 2 where intrahepatic liver injection is planned (NOTE: as of Protocol Amendment 6 [dated 26 October 2021], intrahepatic injections of talimogene laherparepvec and liver biopsies are no longer performed in this study, enrollment for this study has stopped), there should be no macroscopic intravascular invasion of tumors into the main portal vein, hepatic vein, or vena cava. Subjects must not: have active herpetic skin lesions or prior complications of herpetic infection (eg, herpetic keratitis or encephalitis); require treatment with an antiherpetic drug; have received live-virus vaccination within 30 days of planned treatment start; have previous therapy with talimogene laherparepvec, oncolytic viruses, or tumor vaccine. Subjects in the combination treatment cohort must not have: a history or evidence of psychiatric, substance abuse, or any other clinically significant disorder; toxic effects of the most recent prior chemotherapy not resolved to grade 1 or less (except alopecia); or expected other cancer therapy while on study with the exception of local radiation to the site of bone or other metastasis for palliative treatment. Male subjects of reproductive potential in the combination treatment must be willing to use acceptable methods of effective contraception during treatment and through 4 months after the last dose of pembrolizumab.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | United States | ||
| University of California Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40156118 | Derived | Hecht JR, Oberoi A, Garralda Cabanas E, Jae Chon H, Digklia A, Rottey S, Martin Jimenez M, Chaney M, Hippenmeyer J, Lawrence T, Liu K, Hamidi A, Chesney J. Phase Ib/II trial of talimogene laherparepvec alone and with pembrolizumab in advanced solid tumors with liver metastases and hepatocellular carcinoma. Oncologist. 2025 Mar 10;30(3):oyae203. doi: 10.1093/oncolo/oyae203. |
| 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 (or other new use) 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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.
Of the 190 participants screened, 127 participants were enrolled and received study treatment.
127 participants were enrolled at 22 centers in Australia, Europe, South Korea and the United States from February 2016 to July 2023.
As of protocol amendment 6 (dated 26 October 2021), intrahepatic injections of talimogene laherparepvec were no longer performed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Monotherapy Group A | Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 & 2 and up to a volume of 8 mL in Cohorts 3 & 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohorts 1 & 4) or 10^8 PFU/mL (Cohorts 2 & 3). |
| 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 | Oct 26, 2021 | Dec 7, 2022 |
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|
| Pembrolizumab | Drug | Pembrolizumab is a non-Amgen Investigational product that is manufactured by Merck. Pembrolizumab will be labeled, packaged, and distributed by Amgen (or designee) using Amgen (or designee) clinical study drug distribution procedures. Pembrolizumab is supplied as pembrolizumab 100 mg/4 mL vials (25 mg/mL) solution for IV infusion. The trial treatment will consist of a total dose of 200mg administered intravenously every 3 weeks (day 1 of each cycle) for up to 35 cycles. |
|
| Up to 297 weeks |
| Best Overall Response (BOR) Per Modified irRC-RECIST | BOR was defined as the number of participants with a best visit response in the following order: CR, PR, stable disease (SD), progressive disease (PD), or unevaluable (UE) as per modified irRC-RECIST.
| Up to 297 weeks |
| Durable Response Rate (DRR) Per Modified irRC-RECIST | DRR per modified irRC-RECIST was defined as the percentage of participants with an objective response (CR/PR) with a duration of response of at least 6 months.
| Up to 297 weeks |
| Duration of Response (DOR) Per Modified irRC-RECIST | DOR per modified irRC-RECIST was defined as the time from the date of an initial response (CR/PR) that was subsequently confirmed to the earlier of PD or death. DOR was estimated using the Kaplan-Meier method.
| Up to 297 weeks |
| Disease Control Rate (DCR) Per Modified irRC-RECIST | DCR per modified irRC-RECIST was defined as percentage of participants that had a BOR in 1 of the following: CR, PR or SD.
| Up to 297 weeks |
| Progression Free Survival (PFS) Per Modified irRC-RECIST | PFS was defined as the time from first dose to the date of first of PD per modified irRC-RECIST criteria, or death, whichever occurs first. PFS was estimated using the Kaplan-Meier method. Participants that did not have an event of death or disease progression were censored at the latter of their last evaluable tumor assessment date or first dose date.
| Up to 297 weeks |
| Overall Survival (OS) | OS was defined as the time from the date of first dose date to the date of death from any cause. OS time was censored at the last date the participant was known to be alive when the confirmation of death was absent or unknown, or at the date 24 months after the last participant enrolled if the last known to be alive/death date was beyond it. One month = 365.25/12 days. OS was estimated using the Kaplan-Meier method. | Up to 297 weeks |
| Part 1 Only: Number of Participants Who Experienced a TEAE | A TEAE was defined as an event that emerged during treatment, having been absent pretreatment, or worsened relative to the pretreatment state. A treatment-related TEAE was defined as a TEAE that was suspected to be related to the study treatment. | Day 1 to 30 days post-last dose of talimogene laherparepvec or pembrolizumab, whichever is later. The maximum duration of talimogene laherparepvec treatment was 34.1 weeks and pembrolizumab treatment was 98.3 weeks in Part 1. |
| Percentage of Participants With Detectable Talimogene Laherparepvec Deoxyribonucleic Acid (DNA) in Blood | Blood samples were tested using real-time polymerase chain reaction (qPCR). Detectable DNA was defined as a positive result by qPCR analysis. | Week 1 to Week 10 |
| Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Urine | Urine samples were tested using qPCR. Detectable DNA was defined as a positive result by qPCR analysis. | Week 1 to Week 10 |
| Percentage of Participants With Clearance of Talimogene Laherparepvec in Blood | Blood samples were tested using qPCR. A participant was defined as having cleared talimogene laherparepvec if a negative qPCR in a sample was obtained following a prior positive test and if there were no subsequent positive test results in the same cycle. | Cycles 2, 3 and 4: Day 1 pre-dose. Each cycle was 21 days. |
| Percentage of Participants With Clearance of Talimogene Laherparepvec in Urine | Urine samples were tested using qPCR. A participant was defined as having cleared talimogene laherparepvec if a negative qPCR in a sample was obtained following a prior positive test and if there were no subsequent positive test results in the same cycle. | Cycles 2, 3 and 4: Day 1 pre-dose. Each cycle was 21 days. |
| Percentage of Participants With Detectable Talimogene Laherparepvec DNA at the Surface of Injection Site | The number of participants with positive qPCR and subsequent positive plaque assays were evaluated from swabs of skin surface of injections. Detectable DNA was defined as a positive result by qPCR analysis. | Week 1 to Week 10 |
| Percentage of Participants With Detectable Talimogene Laherparepvec Virus at the Surface of Injection Site | The percentage of participants with detectable virus were evaluated from swabs of skin surface of injections. Detectable virus was defined as a positive result by TCID50. | Week 1 to Week 10 |
| Percentage of Participants With Detectable Talimogene Laherparepvec DNA at the Exterior of the Occlusive Dressing | The percentage of participants with positive qPCR and subsequent positive plaque assays were evaluated from swabs of the exterior of the occlusive dressing. Detectable DNA was defined as a positive result by qPCR analysis. | Week 1 to Week 7 |
| Percentage of Participants With Detectable Talimogene Laherparepvec Virus at the Exterior of the Occlusive Dressing | The percentage of participants with detectable virus were evaluated from swabs of the exterior of the occlusive dressings. Detectable virus was defined as a positive result by TCID50. | Week 1 to Week 7 |
| Percentage of Participants With Detectable Talimogene Laherparepvec DNA at the Oral Mucosa | The percentage of participants with positive qPCR and subsequent positive plaque assays were evaluated from swabs of the oral mucosa. Detectable DNA was defined as a positive result by qPCR analysis. | Part 1: Week 1 to Week 37. Part 2: Week 1 to Week 43 |
| Percentage of Participants With Detectable Talimogene Laherparepvec Virus at the Oral Mucosa | The percentage of participants with detectable virus were evaluated from swabs of the oral mucosa. Detectable virus was defined as a positive result by TCID50. | Week 1 to Week 7 |
| Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Lesions Suspected to be Herpetic in Origin | The percentage of participants with positive qPCR were evaluated in any swab of a lesion suspected to be herpetic in origin. Detectable DNA was defined as a positive result by qPCR analysis. Participants returned to the clinic within 3 days of the occurrence of reportable lesion suspected to be herpetic in origin such as cold sores or vesicles. The lesion was evaluated by the Investigator and swabbed if herpes simplex virus infection was suspected. | Day 1 to 30 days post-last dose of talimogene laherparepvec. The maximum duration of talimogene laherparepvec treatment was 102.4 weeks and pembrolizumab treatment was 109.3 weeks. |
| Santa Monica |
| California |
| 90404 |
| United States |
| Georgetown-Howard University Center for Clinical Translational Science | Washington D.C. | District of Columbia | 20007 | United States |
| University of Louisville James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | United States |
| Washington University School of Medicine, Center for Advanced Medicine | St Louis | Missouri | 63110 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Liverpool Hospital | Liverpool | New South Wales | 2170 | Australia |
| Melanoma Institute Australia | North Sydney | New South Wales | 2060 | Australia |
| Tasman Oncology Research | Southport | Queensland | 4215 | Australia |
| Landeskrankenhaus Salzburg | Salzburg | 5020 | Austria |
| Universite Catholique de Louvain Cliniques Universitaires Saint Luc | Brussels | 1200 | Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | 2650 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| Charite Universitätsmedizin Berlin, Charité Campus Virchow-Klinikum | Berlin | 13353 | Germany |
| Universitätsklinikum Bonn | Bonn | 53127 | Germany |
| Kreiskliniken Reutlingen - Klinikum am Steinenberg | Reutlingen | 72764 | Germany |
| Universitätsklinikum Tübingen | Tübingen | 72076 | Germany |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80-214 | Poland |
| Cha Bundang Medical Center, Cha University | Seongnam-si, Gyeonggi-do | 463-712 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | 120-752 | South Korea |
| Hospital Universitari Vall d Hebron | Barcelona | Catalonia | 08035 | Spain |
| Hospital Clinic i Provincial de Barcelona | Barcelona | Catalonia | 08036 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28009 | Spain |
| Hospital Universitario Madrid Sanchinarro | Madrid | 28050 | Spain |
| Hopitaux Universitaires de Geneve | Geneva | 1211 | Switzerland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | 1011 | Switzerland |
| Kantonsspital Winterthur | Winterthur | 8401 | Switzerland |
| Universitaetsspital Zuerich | Zurich | 8091 | Switzerland |
| FG001 | Part 1: Monotherapy Group B | Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 & 2 and up to a volume of 8 mL in Cohorts 3 & 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohorts 1 & 4) or 10^8 PFU/mL (Cohorts 2 & 3). |
| FG002 | Part 1: Combination Therapy Group A | Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 & 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| FG003 | Part 1: Combination Therapy Group B | Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| FG004 | Part 2: Hormone Receptor Positive Breast Cancer (HRBC) | Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| FG005 | Part 2: Triple Negative Breast Cancer (TNBC) | Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| FG006 | Part 2: Cutaneous Squamous Cell Carcinoma (CSCC) | Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| FG007 | Part 2: Basal Cell Carcinoma (BCC) | Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| FG008 | Part 2: Colorectal Adenocarcinoma (CRC) | Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| Received Talimogene Laherparepvec |
|
| Received Pembrolizumab |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set: Part 1 - Included all participants who have received at least 1 dose of talimogene laherparepvec in monotherapy arms, and at least 1 dose of talimogene laherparepvec or at least 1 dose of pembrolizumab in combination arms. Part 2 - Included all participants who have received at least 1 dose of talimogene laherparepvec or at least 1 dose of pembrolizumab.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Monotherapy Group A | Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 & 2 and up to a volume of 8 mL in Cohorts 3 & 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohorts 1 & 4) or 10^8 PFU/mL (Cohorts 2 & 3). |
| BG001 | Part 1: Monotherapy Group B | Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 & 2 and up to a volume of 8 mL in Cohorts 3 & 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohorts 1 & 4) or 10^8 PFU/mL (Cohorts 2 & 3). |
| BG002 | Part 1: Combination Therapy Group A | Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 & 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| BG003 | Part 1: Combination Therapy Group B | Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| BG004 | Part 2: Hormone Receptor Positive Breast Cancer (HRBC) | Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| BG005 | Part 2: Triple Negative Breast Cancer (TNBC) | Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| BG006 | Part 2: Cutaneous Squamous Cell Carcinoma (CSCC) | Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| BG007 | Part 2: Basal Cell Carcinoma (BCC) | Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| BG008 | Part 2: Colorectal Adenocarcinoma (CRC) | Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| BG009 | 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, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||
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| Primary | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | All toxicities were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03:
The occurrence of specific pre-defined toxicities during the DLT evaluation period were considered a DLT if judged by the investigator to be related to talimogene laherparepvec and/or pembrolizumab. All Grade 5 toxicities, intolerable toxicities that lead to permanent discontinuation of talimogene laherparepvec and/or pembrolizumab and Grade 3 or higher AEs related to talimogene laherparepvec and/or pembrolizumab that resulted in a study treatment delay by > 2 weeks were considered DLTs. | DLT Analysis Set: Participants who had at least 1 dose of planned monotherapy or combination treatment and had the opportunity to be on treatment for at least 6 weeks from the initial dosing of study treatment & received at least 1 additional dose of monotherapy or combination or experienced a DLT during the DLT-evaluation period. | Posted | Count of Participants | Participants | Cycle 1 and Cycle 2: Day 1 to Day 21 |
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| Primary | Part 2 Only: Objective Response Rate (ORR) Per Modified Immune-related Response Criteria Simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST). | ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) per modified irRC-RECIST.
| Full Analysis Set (Part 2): Included all participants in Part 2 who received at least 1 dose of talimogene laherparepvec and at least 1 dose of pembrolizumab in combination. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 154 weeks |
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| Primary | Part 2 Only: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | A TEAE was defined as an event that emerged during treatment, having been absent pretreatment, or worsened relative to the pretreatment state. A treatment-related TEAE was defined as a TEAE that was suspected to be related to the study treatment. | Safety Analysis Set (Part 2): Included all participants in Part 2 who have received at least 1 dose of talimogene laherparepvec or at least 1 dose of pembrolizumab. | Posted | Count of Participants | Participants | Day 1 to 30 days post-last dose of talimogene laherparepvec or pembrolizumab, whichever is later. The maximum duration of talimogene laherparepvec treatment was 102.4 weeks and pembrolizumab treatment was 109.3 weeks in Part 2. |
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| Secondary | Part 1 Only: ORR Per Modified irRC-RECIST | ORR was defined as the percentage of participants with a best overall response of CR or PR per modified irRC-RECIST.
| Full Analysis Set (Part 1): Included all participants in Part 1 who received at least 1 dose of talimogene laherparepvec in monotherapy and combination cohorts and at least 1 dose of pembrolizumab in combination cohorts. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 297 weeks |
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| Secondary | Best Overall Response (BOR) Per Modified irRC-RECIST | BOR was defined as the number of participants with a best visit response in the following order: CR, PR, stable disease (SD), progressive disease (PD), or unevaluable (UE) as per modified irRC-RECIST.
| Full Analysis Set: Included all participants who received at least 1 dose of talimogene laherparepvec in monotherapy and combination cohorts and at least 1 dose of pembrolizumab in combination cohorts in Part 1 and Part 2. | Posted | Count of Participants | Participants | Up to 297 weeks |
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| Secondary | Durable Response Rate (DRR) Per Modified irRC-RECIST | DRR per modified irRC-RECIST was defined as the percentage of participants with an objective response (CR/PR) with a duration of response of at least 6 months.
| Full Analysis Set: Included all participants who received at least 1 dose of talimogene laherparepvec in monotherapy and combination cohorts and at least 1 dose of pembrolizumab in combination cohorts in Part 1 and Part 2. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 297 weeks |
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| Secondary | Duration of Response (DOR) Per Modified irRC-RECIST | DOR per modified irRC-RECIST was defined as the time from the date of an initial response (CR/PR) that was subsequently confirmed to the earlier of PD or death. DOR was estimated using the Kaplan-Meier method.
| Full Analysis Set: Included all participants who received at least 1 dose of talimogene laherparepvec in monotherapy and combination cohorts and at least 1 dose of pembrolizumab in combination cohorts in Part 1 and Part 2. Only participants who had a BOR of CR/PR were included. | Posted | Median | 95% Confidence Interval | months | Up to 297 weeks |
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| Secondary | Disease Control Rate (DCR) Per Modified irRC-RECIST | DCR per modified irRC-RECIST was defined as percentage of participants that had a BOR in 1 of the following: CR, PR or SD.
| Full Analysis Set: Included all participants who received at least 1 dose of talimogene laherparepvec in monotherapy and combination cohorts and at least 1 dose of pembrolizumab in combination cohorts in Part 1 and Part 2. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 297 weeks |
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| Secondary | Progression Free Survival (PFS) Per Modified irRC-RECIST | PFS was defined as the time from first dose to the date of first of PD per modified irRC-RECIST criteria, or death, whichever occurs first. PFS was estimated using the Kaplan-Meier method. Participants that did not have an event of death or disease progression were censored at the latter of their last evaluable tumor assessment date or first dose date.
| Full Analysis Set: Included all participants who received at least 1 dose of talimogene laherparepvec in monotherapy and combination cohorts and at least 1 dose of pembrolizumab in combination cohorts in Part 1 and Part 2. | Posted | Median | 95% Confidence Interval | months | Up to 297 weeks |
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| Secondary | Overall Survival (OS) | OS was defined as the time from the date of first dose date to the date of death from any cause. OS time was censored at the last date the participant was known to be alive when the confirmation of death was absent or unknown, or at the date 24 months after the last participant enrolled if the last known to be alive/death date was beyond it. One month = 365.25/12 days. OS was estimated using the Kaplan-Meier method. | Full Analysis Set: Included all participants who received at least 1 dose of talimogene laherparepvec in monotherapy and combination cohorts and at least 1 dose of pembrolizumab in combination cohorts in Part 1 and Part 2. | Posted | Median | 95% Confidence Interval | months | Up to 297 weeks |
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| Secondary | Part 1 Only: Number of Participants Who Experienced a TEAE | A TEAE was defined as an event that emerged during treatment, having been absent pretreatment, or worsened relative to the pretreatment state. A treatment-related TEAE was defined as a TEAE that was suspected to be related to the study treatment. | Safety Analysis Set (Part 1): Included all participants in Part 1 who have received at least 1 dose of talimogene laherparepvec or at least 1 dose of pembrolizumab. | Posted | Count of Participants | Participants | Day 1 to 30 days post-last dose of talimogene laherparepvec or pembrolizumab, whichever is later. The maximum duration of talimogene laherparepvec treatment was 34.1 weeks and pembrolizumab treatment was 98.3 weeks in Part 1. |
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| Secondary | Percentage of Participants With Detectable Talimogene Laherparepvec Deoxyribonucleic Acid (DNA) in Blood | Blood samples were tested using real-time polymerase chain reaction (qPCR). Detectable DNA was defined as a positive result by qPCR analysis. | Blood Evaluable Analysis Set: Included all participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one post dose blood sample collected. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 1 to Week 10 |
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| Secondary | Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Urine | Urine samples were tested using qPCR. Detectable DNA was defined as a positive result by qPCR analysis. | Urine Evaluable Analysis Set: Included all participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one post dose urine sample collected. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 1 to Week 10 |
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| Secondary | Percentage of Participants With Clearance of Talimogene Laherparepvec in Blood | Blood samples were tested using qPCR. A participant was defined as having cleared talimogene laherparepvec if a negative qPCR in a sample was obtained following a prior positive test and if there were no subsequent positive test results in the same cycle. | Blood Clearance Analysis Set: Included participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least 2 post dose samples, collected within the same dosing cycle. Participants must have had at least 1 positive sample and at least 1 subsequent sample at any time during the cycle. All participants included in the overall number of participants contributed analyzed data. | Posted | Number | 95% Confidence Interval | percentage of participants | Cycles 2, 3 and 4: Day 1 pre-dose. Each cycle was 21 days. |
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| Secondary | Percentage of Participants With Clearance of Talimogene Laherparepvec in Urine | Urine samples were tested using qPCR. A participant was defined as having cleared talimogene laherparepvec if a negative qPCR in a sample was obtained following a prior positive test and if there were no subsequent positive test results in the same cycle. | Urine Clearance Analysis Set: Included participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least 2 post dose samples, collected within the same dosing cycle. Participants must have had at least 1 positive sample and at least 1 subsequent sample at any time during the cycle. All participants included in the overall number of participants contributed analyzed data. | Posted | Number | 95% Confidence Interval | percentage of participants | Cycles 2, 3 and 4: Day 1 pre-dose. Each cycle was 21 days. |
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| Secondary | Percentage of Participants With Detectable Talimogene Laherparepvec DNA at the Surface of Injection Site | The number of participants with positive qPCR and subsequent positive plaque assays were evaluated from swabs of skin surface of injections. Detectable DNA was defined as a positive result by qPCR analysis. | Skin Surface of Injections Evaluable Analysis Set: Included participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the skin surface of injections. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 1 to Week 10 |
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| Secondary | Percentage of Participants With Detectable Talimogene Laherparepvec Virus at the Surface of Injection Site | The percentage of participants with detectable virus were evaluated from swabs of skin surface of injections. Detectable virus was defined as a positive result by TCID50. | Skin Surface of Injections Evaluable Analysis Set: Included participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the skin surface of injections. Only participants with a positive surface of injection site qPCR test were included. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 1 to Week 10 |
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| Secondary | Percentage of Participants With Detectable Talimogene Laherparepvec DNA at the Exterior of the Occlusive Dressing | The percentage of participants with positive qPCR and subsequent positive plaque assays were evaluated from swabs of the exterior of the occlusive dressing. Detectable DNA was defined as a positive result by qPCR analysis. | Exterior of Occlusive Dressing Evaluable Analysis Set: Included participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 1 to Week 7 |
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| Secondary | Percentage of Participants With Detectable Talimogene Laherparepvec Virus at the Exterior of the Occlusive Dressing | The percentage of participants with detectable virus were evaluated from swabs of the exterior of the occlusive dressings. Detectable virus was defined as a positive result by TCID50. | Exterior of Occlusive Dressing Evaluable Analysis Set: Included participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing. Only participants with a positive exterior of occlusive dressing qPCR test were included. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 1 to Week 7 |
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| Secondary | Percentage of Participants With Detectable Talimogene Laherparepvec DNA at the Oral Mucosa | The percentage of participants with positive qPCR and subsequent positive plaque assays were evaluated from swabs of the oral mucosa. Detectable DNA was defined as a positive result by qPCR analysis. | Oral Mucosa Evaluable Analysis Set: Included participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the oral mucosa. | Posted | Number | 95% Confidence Interval | percentage of participants | Part 1: Week 1 to Week 37. Part 2: Week 1 to Week 43 |
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| Secondary | Percentage of Participants With Detectable Talimogene Laherparepvec Virus at the Oral Mucosa | The percentage of participants with detectable virus were evaluated from swabs of the oral mucosa. Detectable virus was defined as a positive result by TCID50. | Oral Mucosa Evaluable Analysis Set: Included participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the oral mucosa. Only participants with a positive oral mucosa qPCR test were included. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 1 to Week 7 |
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| Secondary | Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Lesions Suspected to be Herpetic in Origin | The percentage of participants with positive qPCR were evaluated in any swab of a lesion suspected to be herpetic in origin. Detectable DNA was defined as a positive result by qPCR analysis. Participants returned to the clinic within 3 days of the occurrence of reportable lesion suspected to be herpetic in origin such as cold sores or vesicles. The lesion was evaluated by the Investigator and swabbed if herpes simplex virus infection was suspected. | Reactive Swab Analysis Set: Included participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab sample collected from lesions that were suspected to be herpetic in origin. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 to 30 days post-last dose of talimogene laherparepvec. The maximum duration of talimogene laherparepvec treatment was 102.4 weeks and pembrolizumab treatment was 109.3 weeks. |
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From the first dose date to the earlier of 90 days for treatment-emergent SAEs or 30 days for other (non-serious) TEAEs after the last dose date (talimogene laherparepvec or pembrolizumab, whichever is later) or the participants initiate new therapy. Median [min, max] duration of exposure was 6.1 [0.1, 33.1] weeks in Part 1 monotherapy cohorts, 9.2 [0.1, 98.3] weeks in Part 1 combination cohorts and 6.1 [0.1, 109.3] weeks in Part 2. All-cause mortality was reported from Day 1 to up to 297 weeks.
Not provided
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 | Part 1: Monotherapy Group A | Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 & 2 and up to a volume of 8 mL in Cohorts 3 & 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohorts 1 & 4) or 10^8 PFU/mL (Cohorts 2 & 3). | 21 | 23 | 10 | 23 | 23 | 23 |
| EG001 | Part 1: Monotherapy Group B | Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 & 2 and up to a volume of 8 mL in Cohorts 3 & 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohorts 1 & 4) or 10^8 PFU/mL (Cohorts 2 & 3). | 3 | 5 | 2 | 5 | 5 | 5 |
| EG002 | Part 1: Combination Therapy Group A | Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 & 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. | 22 | 24 | 10 | 24 | 24 | 24 |
| EG003 | Part 1: Combination Therapy Group B | Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. | 14 | 22 | 11 | 22 | 21 | 22 |
| EG004 | Part 2: Hormone Receptor Positive Breast Cancer (HRBC) | Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. | 8 | 10 | 4 | 10 | 10 | 10 |
| EG005 | Part 2: Triple Negative Breast Cancer (TNBC) | Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. | 13 | 18 | 7 | 18 | 15 | 18 |
| EG006 | Part 2: Cutaneous Squamous Cell Carcinoma (CSCC) | Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. | 5 | 10 | 5 | 10 | 8 | 10 |
| EG007 | Part 2: Basal Cell Carcinoma (BCC) | Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. | 4 | 5 | 3 | 5 | 5 | 5 |
| EG008 | Part 2: Colorectal Adenocarcinoma (CRC) | Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. | 8 | 10 | 3 | 10 | 10 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hernial eventration | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatic haemorrhage | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatitis cholestatic | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Haemophilus infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Pseudomonal skin infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Procalcitonin increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Soft tissue haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Liver carcinoma ruptured | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Glomerulonephritis proliferative | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Abnormal faeces | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Application site pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site paraesthesia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site ulcer | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hepatomegaly | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Liver tenderness | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Portal vein stenosis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Contrast media allergy | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Immune-mediated adverse reaction | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Herpes simplex viraemia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Injection related reaction | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Post procedural diarrhoea | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Wound haemorrhage | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood creatinine abnormal | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| CD4 lymphocyte percentage decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Creatinine renal clearance increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Fibrin D dimer increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Lymphocyte count abnormal | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Serum ferritin decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Serum ferritin increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Thyroxine free decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Folate deficiency | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Polydipsia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Tumour ulceration | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypergeusia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Mass excision | Surgical and medical procedures | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Campylobacter infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Immunisation reaction | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 26.0 | 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 | Jan 26, 2022 | Dec 7, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000629782 | talimogene laherparepvec |
| C582435 | pembrolizumab |
Not provided
Not provided
Not provided
| 65 - 74 years |
|
| 75 - 84 years |
|
| >= 85 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Other |
|
| OG004 | Part 2: Hormone Receptor Positive Breast Cancer (HRBC) | Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG005 | Part 2: Triple Negative Breast Cancer (TNBC) | Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG006 | Part 2: Cutaneous Squamous Cell Carcinoma (CSCC) | Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG007 | Part 2: Basal Cell Carcinoma (BCC) | Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG008 | Part 2: Colorectal Adenocarcinoma (CRC) | Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG002 | Part 2: Cutaneous Squamous Cell Carcinoma (CSCC) | Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG003 | Part 2: Basal Cell Carcinoma (BCC) | Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG004 | Part 2: Colorectal Adenocarcinoma (CRC) | Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
|
|
| OG002 | Part 2: Cutaneous Squamous Cell Carcinoma (CSCC) | Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG003 | Part 2: Basal Cell Carcinoma (BCC) | Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG004 | Part 2: Colorectal Adenocarcinoma (CRC) | Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
|
|
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 & 2 and up to a volume of 8 mL in Cohorts 3 & 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohorts 1 & 4) or 10^8 PFU/mL (Cohorts 2 & 3).
| OG002 | Part 1: Combination Therapy Group A | Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 & 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG003 | Part 1: Combination Therapy Group B | Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
|
|
| OG001 | Part 1: Monotherapy Group B | Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 & 2 and up to a volume of 8 mL in Cohorts 3 & 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohorts 1 & 4) or 10^8 PFU/mL (Cohorts 2 & 3). |
| OG002 | Part 1: Combination Therapy Group A | Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 & 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG003 | Part 1: Combination Therapy Group B | Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG004 | Part 2: Hormone Receptor Positive Breast Cancer (HRBC) | Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG005 | Part 2: Triple Negative Breast Cancer (TNBC) | Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG006 | Part 2: Cutaneous Squamous Cell Carcinoma (CSCC) | Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG007 | Part 2: Basal Cell Carcinoma (BCC) | Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG008 | Part 2: Colorectal Adenocarcinoma (CRC) | Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
|
|
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 & 2 and up to a volume of 8 mL in Cohorts 3 & 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohorts 1 & 4) or 10^8 PFU/mL (Cohorts 2 & 3).
| OG002 | Part 1: Combination Therapy Group A | Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 & 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG003 | Part 1: Combination Therapy Group B | Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG004 | Part 2: Hormone Receptor Positive Breast Cancer (HRBC) | Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG005 | Part 2: Triple Negative Breast Cancer (TNBC) | Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG006 | Part 2: Cutaneous Squamous Cell Carcinoma (CSCC) | Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG007 | Part 2: Basal Cell Carcinoma (BCC) | Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG008 | Part 2: Colorectal Adenocarcinoma (CRC) | Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
|
|
| OG001 | Part 1: Monotherapy Group B | Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 & 2 and up to a volume of 8 mL in Cohorts 3 & 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohorts 1 & 4) or 10^8 PFU/mL (Cohorts 2 & 3). |
| OG002 | Part 1: Combination Therapy Group A | Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 & 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG003 | Part 1: Combination Therapy Group B | Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG004 | Part 2: Hormone Receptor Positive Breast Cancer (HRBC) | Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG005 | Part 2: Triple Negative Breast Cancer (TNBC) | Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG006 | Part 2: Cutaneous Squamous Cell Carcinoma (CSCC) | Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG007 | Part 2: Basal Cell Carcinoma (BCC) | Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG008 | Part 2: Colorectal Adenocarcinoma (CRC) | Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
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Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 & 2 and up to a volume of 8 mL in Cohorts 3 & 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohorts 1 & 4) or 10^8 PFU/mL (Cohorts 2 & 3). |
| OG002 | Part 1: Combination Therapy Group A | Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 & 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG003 | Part 1: Combination Therapy Group B | Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG004 | Part 2: Hormone Receptor Positive Breast Cancer (HRBC) | Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG005 | Part 2: Triple Negative Breast Cancer (TNBC) | Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG006 | Part 2: Cutaneous Squamous Cell Carcinoma (CSCC) | Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG007 | Part 2: Basal Cell Carcinoma (BCC) | Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG008 | Part 2: Colorectal Adenocarcinoma (CRC) | Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
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Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 & 2 and up to a volume of 8 mL in Cohorts 3 & 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohorts 1 & 4) or 10^8 PFU/mL (Cohorts 2 & 3).
| OG002 | Part 1: Combination Therapy Group A | Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 & 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG003 | Part 1: Combination Therapy Group B | Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG004 | Part 2: Hormone Receptor Positive Breast Cancer (HRBC) | Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG005 | Part 2: Triple Negative Breast Cancer (TNBC) | Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG006 | Part 2: Cutaneous Squamous Cell Carcinoma (CSCC) | Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG007 | Part 2: Basal Cell Carcinoma (BCC) | Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG008 | Part 2: Colorectal Adenocarcinoma (CRC) | Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
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| OG002 | Part 1: Combination Therapy Group A | Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 & 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG003 | Part 1: Combination Therapy Group B | Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG004 | Part 2: Hormone Receptor Positive Breast Cancer (HRBC) | Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG005 | Part 2: Triple Negative Breast Cancer (TNBC) | Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG006 | Part 2: Cutaneous Squamous Cell Carcinoma (CSCC) | Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG007 | Part 2: Basal Cell Carcinoma (BCC) | Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG008 | Part 2: Colorectal Adenocarcinoma (CRC) | Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
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| OG002 | Part 1: Combination Therapy Group A | Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 & 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG003 | Part 1: Combination Therapy Group B | Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
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| OG002 | Part 1: Combination Therapy Group A | Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 & 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG003 | Part 1: Combination Therapy Group B | Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG004 | Part 2: Hormone Receptor Positive Breast Cancer (HRBC) | Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG005 | Part 2: Triple Negative Breast Cancer (TNBC) | Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG006 | Part 2: Cutaneous Squamous Cell Carcinoma (CSCC) | Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG007 | Part 2: Basal Cell Carcinoma (BCC) | Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG008 | Part 2: Colorectal Adenocarcinoma (CRC) | Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
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| OG002 | Part 1: Combination Therapy Group A | Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 & 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG003 | Part 1: Combination Therapy Group B | Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG004 | Part 2: Hormone Receptor Positive Breast Cancer (HRBC) | Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG005 | Part 2: Triple Negative Breast Cancer (TNBC) | Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG006 | Part 2: Cutaneous Squamous Cell Carcinoma (CSCC) | Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG007 | Part 2: Basal Cell Carcinoma (BCC) | Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG008 | Part 2: Colorectal Adenocarcinoma (CRC) | Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
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| OG002 | Part 1: Combination Therapy Group A | Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 & 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG003 | Part 1: Combination Therapy Group B | Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG004 | Part 2: Hormone Receptor Positive Breast Cancer (HRBC) | Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG005 | Part 2: Triple Negative Breast Cancer (TNBC) | Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG006 | Part 2: Cutaneous Squamous Cell Carcinoma (CSCC) | Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG007 | Part 2: Basal Cell Carcinoma (BCC) | Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG008 | Part 2: Colorectal Adenocarcinoma (CRC) | Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
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| OG002 | Part 1: Combination Therapy Group A | Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 & 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG003 | Part 1: Combination Therapy Group B | Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG004 | Part 2: Hormone Receptor Positive Breast Cancer (HRBC) | Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG005 | Part 2: Triple Negative Breast Cancer (TNBC) | Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG006 | Part 2: Cutaneous Squamous Cell Carcinoma (CSCC) | Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG007 | Part 2: Basal Cell Carcinoma (BCC) | Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG008 | Part 2: Colorectal Adenocarcinoma (CRC) | Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
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| OG002 | Part 1: Combination Therapy Group A | Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 & 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG003 | Part 1: Combination Therapy Group B | Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG004 | Part 2: Hormone Receptor Positive Breast Cancer (HRBC) | Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG005 | Part 2: Triple Negative Breast Cancer (TNBC) | Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG006 | Part 2: Cutaneous Squamous Cell Carcinoma (CSCC) | Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG007 | Part 2: Basal Cell Carcinoma (BCC) | Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG008 | Part 2: Colorectal Adenocarcinoma (CRC) | Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
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| OG002 | Part 1: Combination Therapy Group A | Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 & 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG003 | Part 1: Combination Therapy Group B | Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG004 | Part 2: Hormone Receptor Positive Breast Cancer (HRBC) | Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG005 | Part 2: Triple Negative Breast Cancer (TNBC) | Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG006 | Part 2: Cutaneous Squamous Cell Carcinoma (CSCC) | Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG007 | Part 2: Basal Cell Carcinoma (BCC) | Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG008 | Part 2: Colorectal Adenocarcinoma (CRC) | Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
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| OG002 | Part 1: Combination Therapy Group A | Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 & 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG003 | Part 1: Combination Therapy Group B | Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG004 | Part 2: Hormone Receptor Positive Breast Cancer (HRBC) | Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG005 | Part 2: Triple Negative Breast Cancer (TNBC) | Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG006 | Part 2: Cutaneous Squamous Cell Carcinoma (CSCC) | Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG007 | Part 2: Basal Cell Carcinoma (BCC) | Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG008 | Part 2: Colorectal Adenocarcinoma (CRC) | Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
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| OG002 | Part 1: Combination Therapy Group A | Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 & 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG003 | Part 1: Combination Therapy Group B | Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG004 | Part 2: Hormone Receptor Positive Breast Cancer (HRBC) | Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG005 | Part 2: Triple Negative Breast Cancer (TNBC) | Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG006 | Part 2: Cutaneous Squamous Cell Carcinoma (CSCC) | Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG007 | Part 2: Basal Cell Carcinoma (BCC) | Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG008 | Part 2: Colorectal Adenocarcinoma (CRC) | Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
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| OG002 | Part 1: Combination Therapy Group A | Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 & 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG003 | Part 1: Combination Therapy Group B | Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG004 | Part 2: Hormone Receptor Positive Breast Cancer (HRBC) | Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG005 | Part 2: Triple Negative Breast Cancer (TNBC) | Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG006 | Part 2: Cutaneous Squamous Cell Carcinoma (CSCC) | Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG007 | Part 2: Basal Cell Carcinoma (BCC) | Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG008 | Part 2: Colorectal Adenocarcinoma (CRC) | Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
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| OG002 | Part 1: Combination Therapy Group A | Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 & 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG003 | Part 1: Combination Therapy Group B | Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG004 | Part 2: Hormone Receptor Positive Breast Cancer (HRBC) | Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG005 | Part 2: Triple Negative Breast Cancer (TNBC) | Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG006 | Part 2: Cutaneous Squamous Cell Carcinoma (CSCC) | Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG007 | Part 2: Basal Cell Carcinoma (BCC) | Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG008 | Part 2: Colorectal Adenocarcinoma (CRC) | Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
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| Part 1: Monotherapy Group B |
Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 1 & 2 and up to a volume of 8 mL in Cohorts 3 & 4 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohorts 1 & 4) or 10^8 PFU/mL (Cohorts 2 & 3). |
| OG002 | Part 1: Combination Therapy Group A | Participants with non-hepatocellular carcinoma (non-HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5 & 6 on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG003 | Part 1: Combination Therapy Group B | Participants with hepatocellular carcinoma (HCC) were administered talimogene laherparepvec by intralesional injection at an initial concentration of 10^6 plaque forming unit (PFU)/mL in a volume of up to 4mL in Cohorts 5, 6a (participants without viral hepatitis) and 6b (participants with well controlled viral hepatitis) on Day 1 of the first 21-day cycle. The concentration of talimogene laherparepvec doses in the second and subsequent 21-day cycles were 10^7 (Cohort 5) or 10^8 PFU/mL (Cohorts 6a and 6b). Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG004 | Part 2: Hormone Receptor Positive Breast Cancer (HRBC) | Participants with HRBC were administered talimogene laherparepvec by intralesional injection at the maximum tolerated concentration (MTC) and maximum tolerated volume (MTV) identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG005 | Part 2: Triple Negative Breast Cancer (TNBC) | Participants with TNBC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG006 | Part 2: Cutaneous Squamous Cell Carcinoma (CSCC) | Participants with CSCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG007 | Part 2: Basal Cell Carcinoma (BCC) | Participants with BCC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
| OG008 | Part 2: Colorectal Adenocarcinoma (CRC) | Participants with CRC were administered talimogene laherparepvec by intralesional injection at the MTC and MTV identified in Part 1 on Day 1 of each 21-day cycle. Participants were also administered 200 mg of pembrolizumab on Day 1 of each 21-day cycle as an intravenous infusion. |
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