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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02509507
Registration number
NCT02509507
Ethics application status
Date submitted
10/07/2015
Date registered
28/07/2015
Titles & IDs
Public title
Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Tumors Alone and in Combination With Systemic Pembrolizumab MK-3475-611/Keynote-611
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Scientific title
A Phase 1b/2, Multicenter, Open-label, Basket Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Liver Tumors Alone and in Combination With Systemic Pembrolizumab in Phase 1b and to Evaluate the Efficacy and Safety of Intratumoral Talimogene Laherparepvec in Combination With Systemic Pembrolizumab to Treat Subjects With Advanced Solid Tumors in Phase 2 (MASTERKEY-318)
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Secondary ID [1]
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0
2014-005386-67
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Secondary ID [2]
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0
20140318
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Universal Trial Number (UTN)
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Trial acronym
MASTERKEY-318
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatocellular Carcinoma
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0
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Liver Metastases
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0
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Cutaneous or Subcutaneous Lymph Node
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0
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Liver Tumors
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0
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Condition category
Condition code
Cancer
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0
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0
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Liver
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Oral and Gastrointestinal
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0
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Talimogene Laherparepvec
Treatment: Drugs - Pembrolizumab
Experimental: Phase Ib/II Talimogene Laherparepvec - Talimogene Laherparepvec
Experimental: Phase Ib/II Talimogene Laherparepvec + Pembrolizumab - Combination treatment of Talimogene Laherparepvec and Pembrolizumab
Treatment: Drugs: Talimogene Laherparepvec
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.
Treatment: Drugs: Pembrolizumab
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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
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Assessment method [1]
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All toxicities were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03:
* Grade 1: Mild
* Grade 2: Moderate
* Grade 3: Severe or medically significant but not immediately life threatening
* Grade 4: Life threatening consequences
* Grade 5: Death related to adverse event (AE)
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.
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Timepoint [1]
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Cycle 1 and Cycle 2: Day 1 to Day 21
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Primary outcome [2]
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Part 2 Only: Objective Response Rate (ORR) Per Modified Immune-related Response Criteria Simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST).
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Assessment method [2]
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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.
* CR: Disappearance of all lesions (whether measurable or not and whether baseline or new) and confirmation by a repeat, consecutive assessment no less than 4 weeks (28 days) from the date first documented. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
* PR: Decrease in tumor burden = 30% relative to baseline confirmed by a consecutive assessment at least 4 weeks (28 days) after first documentation.
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Timepoint [2]
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Up to 154 weeks
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Primary outcome [3]
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Part 2 Only: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
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Assessment method [3]
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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.
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Timepoint [3]
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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 outcome [1]
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Part 1 Only: ORR Per Modified irRC-RECIST
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Assessment method [1]
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ORR was defined as the percentage of participants with a best overall response of CR or PR per modified irRC-RECIST.
* CR: Disappearance of all lesions (whether measurable or not and whether baseline or new) and confirmation by a repeat, consecutive assessment no less than 4 weeks (28 days) from the date first documented. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
* PR: Decrease in tumor burden = 30% relative to baseline confirmed by a consecutive assessment at least 4 weeks (28 days) after first documentation.
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Timepoint [1]
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Up to 297 weeks
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Secondary outcome [2]
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Best Overall Response (BOR) Per Modified irRC-RECIST
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Assessment method [2]
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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.
* CR: Disappearance of all lesions and confirmation by assessment no less than 4 weeks (28 days) from the date first documented. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
* PR: Decrease in tumor burden = 30% relative to baseline confirmed by a consecutive assessment at least 4 weeks (28 days) after first documentation.
* SD: Neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD.
* PD: Increase in tumor burden = 20 % and at least 5 mm absolute increase relative to nadir confirmation by a repeat, consecutive assessment no less than 4 weeks (28 days) from the date first documented PD.
* UE: Any lesion present at baseline which was not assessed or was unable to be evaluated.
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Timepoint [2]
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Up to 297 weeks
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Secondary outcome [3]
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Durable Response Rate (DRR) Per Modified irRC-RECIST
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Assessment method [3]
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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.
* CR: Disappearance of all lesions and confirmation by assessment no less than 4 weeks (28 days) from the date first documented. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
* PR: Decrease in tumor burden = 30% relative to baseline confirmed by a consecutive assessment at least 4 weeks (28 days) after first documentation.
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Timepoint [3]
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Up to 297 weeks
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Secondary outcome [4]
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Duration of Response (DOR) Per Modified irRC-RECIST
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Assessment method [4]
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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.
* CR: Disappearance of all lesions and confirmation by assessment no less than 4 weeks (28 days) from the date first documented. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
* PR: Decrease in tumor burden = 30% relative to baseline confirmed by a consecutive assessment at least 4 weeks (28 days) after first documentation.
* PD: Increase in tumor burden = 20 % and at least 5 mm absolute increase relative to nadir confirmation by a repeat, consecutive assessment no less than 4 weeks (28 days) from the date first documented PD.
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Timepoint [4]
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Up to 297 weeks
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Secondary outcome [5]
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Disease Control Rate (DCR) Per Modified irRC-RECIST
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Assessment method [5]
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DCR per modified irRC-RECIST was defined as percentage of participants that had a BOR in 1 of the following: CR, PR or SD.
* CR: Disappearance of all lesions and confirmation by assessment no less than 4 weeks (28 days) from the date first documented. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
* PR: Decrease in tumor burden = 30% relative to baseline confirmed by a consecutive assessment at least 4 weeks (28 days) after first documentation.
* SD: Neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD.
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Timepoint [5]
0
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Up to 297 weeks
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Secondary outcome [6]
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Progression Free Survival (PFS) Per Modified irRC-RECIST
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Assessment method [6]
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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.
* PD: Increase in tumor burden = 20 % and at least 5 mm absolute increase relative to nadir confirmation by a repeat, consecutive assessment no less than 4 weeks (28 days) from the date first documented PD.
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Timepoint [6]
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Up to 297 weeks
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Secondary outcome [7]
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Overall Survival (OS)
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Assessment method [7]
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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.
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Timepoint [7]
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Up to 297 weeks
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Secondary outcome [8]
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0
Part 1 Only: Number of Participants Who Experienced a TEAE
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Assessment method [8]
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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.
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Timepoint [8]
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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 outcome [9]
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Percentage of Participants With Detectable Talimogene Laherparepvec Deoxyribonucleic Acid (DNA) in Blood
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Assessment method [9]
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Blood samples were tested using real-time polymerase chain reaction (qPCR). Detectable DNA was defined as a positive result by qPCR analysis.
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Timepoint [9]
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Week 1 to Week 10
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Secondary outcome [10]
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Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Urine
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Assessment method [10]
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Urine samples were tested using qPCR. Detectable DNA was defined as a positive result by qPCR analysis.
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Timepoint [10]
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Week 1 to Week 10
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Secondary outcome [11]
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Percentage of Participants With Clearance of Talimogene Laherparepvec in Blood
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Assessment method [11]
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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.
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Timepoint [11]
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Cycles 2, 3 and 4: Day 1 pre-dose. Each cycle was 21 days.
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Secondary outcome [12]
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Percentage of Participants With Clearance of Talimogene Laherparepvec in Urine
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Assessment method [12]
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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.
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Timepoint [12]
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Cycles 2, 3 and 4: Day 1 pre-dose. Each cycle was 21 days.
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Secondary outcome [13]
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Percentage of Participants With Detectable Talimogene Laherparepvec DNA at the Surface of Injection Site
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Assessment method [13]
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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.
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Timepoint [13]
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Week 1 to Week 10
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Secondary outcome [14]
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Percentage of Participants With Detectable Talimogene Laherparepvec Virus at the Surface of Injection Site
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Assessment method [14]
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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.
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Timepoint [14]
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Week 1 to Week 10
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Secondary outcome [15]
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Percentage of Participants With Detectable Talimogene Laherparepvec DNA at the Exterior of the Occlusive Dressing
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Assessment method [15]
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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.
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Timepoint [15]
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Week 1 to Week 7
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Secondary outcome [16]
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Percentage of Participants With Detectable Talimogene Laherparepvec Virus at the Exterior of the Occlusive Dressing
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Assessment method [16]
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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.
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Timepoint [16]
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Week 1 to Week 7
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Secondary outcome [17]
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Percentage of Participants With Detectable Talimogene Laherparepvec DNA at the Oral Mucosa
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Assessment method [17]
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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.
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Timepoint [17]
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Part 1: Week 1 to Week 37. Part 2: Week 1 to Week 43
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Secondary outcome [18]
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Percentage of Participants With Detectable Talimogene Laherparepvec Virus at the Oral Mucosa
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Assessment method [18]
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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.
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Timepoint [18]
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Week 1 to Week 7
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Secondary outcome [19]
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Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Lesions Suspected to be Herpetic in Origin
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Assessment method [19]
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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.
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Timepoint [19]
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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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Eligibility
Key inclusion criteria
Summary of Subject Eligibility Criteria:
Key
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 Hormone receptor positive Breast Cancer Arm only: Histologically and/or cytologically confirmed diagnosis of estrogen receptor (ER) positive and/or progesterone receptor (PrR) positive breast cancer.
* Triple negative breast cancer: Histologically and/or cytologically confirmed diagnosis of ER negative, PrR negative, human epidermal growth factor receptor 2 (HER2)-Neu negative.
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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/02/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
11/07/2023
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Sample size
Target
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Accrual to date
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Final
127
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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0
Liverpool Hospital - Liverpool
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Recruitment hospital [2]
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Melanoma Institute Australia - North Sydney
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Recruitment hospital [3]
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Tasman Oncology Research - Southport
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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2060 - North Sydney
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Recruitment postcode(s) [3]
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4215 - Southport
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
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0
Arizona
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0
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United States of America
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California
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0
0
United States of America
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District of Columbia
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United States of America
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0
Kentucky
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0
0
United States of America
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0
Missouri
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0
0
United States of America
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0
New Jersey
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0
0
United States of America
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New York
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0
0
United States of America
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Pennsylvania
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0
0
United States of America
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Texas
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0
0
Austria
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State/province [10]
0
0
Salzburg
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0
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Belgium
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State/province [11]
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Bruxelles
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0
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Belgium
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Edegem
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0
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Belgium
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0
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Gent
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0
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Germany
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0
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Berlin
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0
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Germany
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0
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Bonn
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0
0
Germany
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State/province [16]
0
0
Reutlingen
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0
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Germany
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State/province [17]
0
0
Tübingen
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0
0
Korea, Republic of
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0
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Seongnam-si, Gyeonggi-do
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0
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Korea, Republic of
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Seoul
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0
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Poland
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0
0
Gdansk
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0
0
Spain
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0
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Cataluña
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0
0
Spain
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0
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Madrid
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0
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Switzerland
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Geneva 14
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0
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Switzerland
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0
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Lausanne
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0
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Switzerland
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0
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Winterthur
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0
0
Switzerland
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State/province [26]
0
0
Zurich
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Amgen
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Other collaborator category [1]
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Commercial sector/industry
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Merck Sharp & Dohme LLC
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Ethics approval
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/study/NCT02509507
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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MD
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Amgen
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
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.
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Available to whom?
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.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.amgen.com/datasharing
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/07/NCT02509507/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/07/NCT02509507/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02509507