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| Name | Class |
|---|---|
| Roche-Genentech | INDUSTRY |
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Approximately 36 DLT-evaluable subjects will be enrolled in this study. The locations of the study will be in the United States, Australia, Europe and Switzerland.
The goal of this study is to evaluate the safety of intrahepatic injection (directly into the liver) of talimogene laherparepvec in combination with intravenously administered atezolizumab in subjects with triple negative breast cancer and colorectal cancer with liver metastases.
The Screening period is 28 days prior to study enrollment. This study has 2 Cohorts. Cohort 1: Triple Negative Breast Cancer and Cohort 2: Colorectal Cancer. These cohorts will enroll in parallel. There will be a Safety Follow-up period and a Long Term Follow-up period.
Drug Administration: The participants will receive the study drugs in cycles. If the participants are found to be eligible to take part in this study, they will receive talimogene laherparepvec as an injection into the hepatic (liver) metastatic sites on Day 1 of each cycle along with receiving atezolizumab by intravenous infusion on Day 1 of each cycle. Each cycle is 21 days for 6 cycles. There is an option for an additional 6 cycles after the first 6 intra-hepatic cycles. After the first radiographic assessment at week 10, if all injectable liver lesions have been injected but the 4.0 mL maximum volume has not been used, injection of clinically assessed non-hepatic cutaneous, subcutaneous, and nodal tumor lesions with or without ultrasound guidance will be permitted. Liver lesions should be prioritized over cutaneous, subcutaneous and nodal lesions.
Treatment will continue until a participant experiences a DLT (Dose Limiting Toxicity) evaluated in the DLT period (which is 2 cycles from initial dose), has CR (Complete Response), has need for an alternative anticancer therapy or experiences a safety concern.
Study Visits: Cycle 1 to Cycle 12 - The participant will have a physical exam along with vital signs and ECOG (Eastern Cooperative Oncology Group) performance level assessment. Blood (about 2 Tablespoons) will be drawn for routine tests and to check the immune system. Adverse events and medications taken will be reviewed on each cycle.Biomarkers will be taken on cycles 1, 2, 3, 6, and safety FU. Tumor Markers (special lab tests associated with the cancer, such as particular proteins) will be completed will be take on cycles 1, 4, 7, 10, 13, every 3 cycles and SFU.
Central lab tests will be completed on cycles 1, 2, 3, and 6 and safety FU. Cycle 1 Archived (prior stored) tumor sample will be obtained. Also, a liver tumor biopsy will be completed at Cycles 1, 3 and 6.
Response Assessments will be completed at Screening and again at Cycles 4, 7, 10, 13 and every 3 cycles.
Throughout the trial a swab for Herpetic tumor will be obtained within 3 days of the event.
Cycle 1 to 12- The exposure to talimogene laherparepvec by the subject's healthcare provider and household member caregiver will be reviewed. Cycles 1, 3, 6-Liver tumor biopsy will be completed. Cycles 4, 7, 10, 13 and every 3 cycles -Response assessments will be completed by radiographic and clinical tumor assessment.
Length of Treatment:
A maximum for 12 cycles of talimogene laherparepvec are allowed during the study. The participant may continue taking the study drug for as long as the doctor thinks it is in their best interest. The participant will no longer be able to take the study drug if the disease gets worse, or if they are unable to follow study directions.
Safety Follow-up Visit:
Safety Follow-up visit will be performed about 30 days after the last dose of study treatment.
The participant will have a physical exam, have vital signs taken, assessment of ECOG status and have weight measured. Adverse events will be assessed as well as the concominant medications. Routine bloodwork and tumor markers will be taken.
Exposure to talimogene laherparepvec by the healthcare providers of the participant and/or close contacts will be assessed.
Long-Term Follow-up Visits: Participants will be followed for survival every 12 weeks from the date of the safety follow-up visit until approximately 24 months after the last subject is enrolled. Subsequent cancer treatments will be collected as part of the long-term follow-up survival assessment. This is an investigational study. The study doctor can explain how the study drugs are designed to work.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Talimogene Laherparepvec with Atezolizumab: Triple Negative Breast Cancer (TNBC) | Experimental | Participants with TNBC with liver metastases administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle is 21 days. Participants administered 10^6 plaque-forming units/milliliter (PFU/mL) on Day 1 of Cycle 1 and 10^8 PFU/mL on Day 1 of each cycle thereafter. Participants also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle. |
|
| Talimogene Laherparepvec with Atezolizumab: Colorectal Cancer (CRC) | Experimental | Participants with CRC with liver metastases administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle is 21 days. Participants administered 10^6 PFU/mL on Day 1 of Cycle 1 and 10^8 PFU/mL on Day 1 of each cycle thereafter. Participants also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talimogene Laherparepvec | Biological | Virally based anti-cancer immunotherapy given by direct injection into tumors. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT) | Toxicities were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. A DLT was considered as any of the below, if judged by the investigator to be related to either treatment:
DLTs were to occur within the DLT evaluation period, defined as the period between the initial 10^6 PFU/mL dose and 3 weeks following the initial 10^8 PFU/mL dose or the start of Cycle 3, whichever occurred first. | From Day 1 up to the start of Cycle 3 (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR was defined as the incidence rate of either a complete response (CR) or partial response (PR) based on modified immune-related response criteria simulating Response Evaluation Criteria in Solid Tumors(irRC-RECIST) criteria. A CR was a complete disappearance of all lesions and a PR was a decrease in tumor burden 30% or more relative to baseline. | Every 12 weeks (± 28 days) up to approximately 3.5 years. |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles | Los Angeles | California | 90095 | United States | ||
| Columbia University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36863095 | Background | Hecht JR, Raman SS, Chan A, Kalinsky K, Baurain JF, Jimenez MM, Garcia MM, Berger MD, Lauer UM, Khattak A, Carrato A, Zhang Y, Liu K, Cha E, Keegan A, Bhatta S, Strassburg CP, Roohullah A. Phase Ib study of talimogene laherparepvec in combination with atezolizumab in patients with triple negative breast cancer and colorectal cancer with liver metastases. ESMO Open. 2023 Apr;8(2):100884. doi: 10.1016/j.esmoop.2023.100884. Epub 2023 Feb 28. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Participants were enrolled between 19 March 2018 and 03 December 2021. A total of 11 subjects with triple negative breast cancer were enrolled and 25 subjects with colorectal cancer.
Participants were enrolled at 15 research centers in Australia, Belgium, Germany, Spain, Switzerland and the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) | Participants with TNBC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10^6 plaque-forming units/milliliter (PFU/mL) on Day 1 of Cycle 1 and 10^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle. |
| 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 | Jul 8, 2019 | May 13, 2021 |
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|
| Atezolizumab | Biological | A monoclonal antibody given by intravenous injection. |
|
|
| Best Overall Response (BOR) | BOR was defined as the best visit response based on modified irRC-RECIST criteria:
| Every 12 weeks (± 28 days) up to approximately 3.5 years. |
| Duration of Response (DOR) | DOR was defined as the time from the date of an initial response that is subsequently confirmed to the earlier of PD per modified irRC RECIST or death. Participants who have not ended their response at the time of analysis were censored at the last evaluable tumor assessment. | Every 12 weeks (± 28 days) up to approximately 3.5 years. |
| Lesion Level Response in Injected Tumor Lesions | Responses for individual tumor lesions for hepatic and non-hepatic tumors injected wtih treatment were assessed for the following responses:
| Every 12 weeks (± 28 days) up to approximately 3.5 years. |
| Lesion Level Response in Uninjected Tumor Lesions | Responses for individual tumor lesions for hepatic and non-hepatic tumors that were not injected with treatment were assessed for the following responses:
| Every 12 weeks (± 28 days) up to approximately 3.5 years. |
| Durable Response Rate (DRR) | DRR was defined as the percentage of participants with an objective response with a DOR of at least 6 months. | Every 12 weeks (± 28 days) up to approximately 3.5 years. |
| Disease Control Rate (DCR) | DCR was defined as the percentage of participants that have a best overall response in one of the following categories: CR/PR/SD. | Every 12 weeks (± 28 days) up to approximately 3.5 years. |
| Progression-free Survival (PFS) | PFS was defined as time from first dose to the date of first of confirmed disease progression per modified irRC-RECIST criteria, or death (whichever occurred first). Results were estimated using the Kaplan-Meier method. | Every 12 weeks (± 28 days) up to approximately 3.5 years. |
| Overall Survival (OS) | OS was defined as the time from the date of first dose to the date of death from any cause. Results were estimated using the Kaplan-Meier method. | Every 12 weeks (± 28 days) up to approximately 3.5 years. |
| New York |
| New York |
| 10032 |
| United States |
| Stony Brook University | Stony Brook | New York | 11794-9446 | United States |
| Liverpool Hospital | Liverpool | New South Wales | 2170 | Australia |
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| Fiona Stanley Hospital | Murdoch | Western Australia | 6150 | Australia |
| Breast Cancer Research Centre - WA | Nedlands | Western Australia | 6009 | Australia |
| Universite Catholique de Louvain Cliniques Universitaires Saint Luc | Brussels | 1200 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| Charite Universitätsmedizin Berlin, Charité Campus Virchow-Klinikum | Berlin | 13353 | Germany |
| Universitätsklinikum Bonn | Bonn | 53105 | Germany |
| Universitätsklinik Tübingen | Tübingen | 72076 | Germany |
| Hospital del Mar | Barcelona | Cataluña | 08003 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28007 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Inselspital Bern | Bern | 3010 | Switzerland |
| Hopitaux Universitaires de Geneve | Geneva | 1211 | Switzerland |
| FG001 | Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) | Participants with CRC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10^6 PFU/mL on Day 1 of Cycle 1 and 10^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle. |
| Received Talimogene Laherparepvec |
|
| Received Atezolizumab |
|
| Safety Analysis Set | All participants who received at least 1 dose of talimogene laherparepvec or atezolizumab. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) | Participants with TNBC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10^6 plaque-forming units/milliliter (PFU/mL) on Day 1 of Cycle 1 and 10^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle. |
| BG001 | Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) | Participants with CRC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10^6 PFU/mL on Day 1 of Cycle 1 and 10^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle. |
| BG002 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT) | Toxicities were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. A DLT was considered as any of the below, if judged by the investigator to be related to either treatment:
DLTs were to occur within the DLT evaluation period, defined as the period between the initial 10^6 PFU/mL dose and 3 weeks following the initial 10^8 PFU/mL dose or the start of Cycle 3, whichever occurred first. | DLT Analysis Set: All participants who had opportunity to receive treatment for 2 cycles from the time of initial dose of study treatment and who had received 2 doses of talimogene laherparepvec and 2 doses of atezolizumab in combination or had a DLT during the DLT-evaluation period. | Posted | Count of Participants | Participants | From Day 1 up to the start of Cycle 3 (each cycle is 21 days) |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Objective Response Rate (ORR) | ORR was defined as the incidence rate of either a complete response (CR) or partial response (PR) based on modified immune-related response criteria simulating Response Evaluation Criteria in Solid Tumors(irRC-RECIST) criteria. A CR was a complete disappearance of all lesions and a PR was a decrease in tumor burden 30% or more relative to baseline. | Safety Analysis Set: All participants who received at least 1 dose of talimogene laherparepvec or atezolizumab. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Every 12 weeks (± 28 days) up to approximately 3.5 years. |
| ||||||||||||||||||||||||||||||
| Secondary | Best Overall Response (BOR) | BOR was defined as the best visit response based on modified irRC-RECIST criteria:
| Safety Analysis Set: All participants who received at least 1 dose of talimogene laherparepvec or atezolizumab. | Posted | Count of Participants | Participants | Every 12 weeks (± 28 days) up to approximately 3.5 years. |
| |||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR was defined as the time from the date of an initial response that is subsequently confirmed to the earlier of PD per modified irRC RECIST or death. Participants who have not ended their response at the time of analysis were censored at the last evaluable tumor assessment. | Responders in Safety Analysis Set: All participants in safety analysis set who received at least 1 dose of talimogene laherparepvec or atezolizumab who had a best overall response of CR/PR at the time of analysis. | Posted | Median | Full Range | Months | Every 12 weeks (± 28 days) up to approximately 3.5 years. |
| ||||||||||||||||||||||||||||||
| Secondary | Lesion Level Response in Injected Tumor Lesions | Responses for individual tumor lesions for hepatic and non-hepatic tumors injected wtih treatment were assessed for the following responses:
| Injected Lesion Analysis Set: Any target lesion and new measurable lesion that was injected from the participants who had received at least 1 dose of talimogene laherparepvec or atezolizumab. | Posted | Count of Units | Lesions | Every 12 weeks (± 28 days) up to approximately 3.5 years. | Lesions | Lesions |
| |||||||||||||||||||||||||||||
| Secondary | Lesion Level Response in Uninjected Tumor Lesions | Responses for individual tumor lesions for hepatic and non-hepatic tumors that were not injected with treatment were assessed for the following responses:
| Uninjected Lesion Analysis Set: Any target lesion and new measurable lesion that was never injected from the participants who had received at least 1 dose of talimogene laherparepvec or atezolizumab. | Posted | Count of Units | Lesions | Every 12 weeks (± 28 days) up to approximately 3.5 years. | Lesions | Lesions |
| |||||||||||||||||||||||||||||
| Secondary | Durable Response Rate (DRR) | DRR was defined as the percentage of participants with an objective response with a DOR of at least 6 months. | Safety Analysis Set: All participants who received at least 1 dose of talimogene laherparepvec or atezolizumab. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Every 12 weeks (± 28 days) up to approximately 3.5 years. |
| ||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | DCR was defined as the percentage of participants that have a best overall response in one of the following categories: CR/PR/SD. | Safety Analysis Set: All participants who received at least 1 dose of talimogene laherparepvec or atezolizumab. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Every 12 weeks (± 28 days) up to approximately 3.5 years. |
| ||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | PFS was defined as time from first dose to the date of first of confirmed disease progression per modified irRC-RECIST criteria, or death (whichever occurred first). Results were estimated using the Kaplan-Meier method. | Safety Analysis Set: All participants who received at least 1 dose of talimogene laherparepvec or atezolizumab. | Posted | Median | 95% Confidence Interval | Months | Every 12 weeks (± 28 days) up to approximately 3.5 years. |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from the date of first dose to the date of death from any cause. Results were estimated using the Kaplan-Meier method. | Safety Analysis Set: All participants who received at least 1 dose of talimogene laherparepvec or atezolizumab. | Posted | Median | 95% Confidence Interval | Months | Every 12 weeks (± 28 days) up to approximately 3.5 years. |
|
Day 1 up to approximately 3.5 years.
All-Cause Mortality is reported for all enrolled participants. Serious and Other Adverse Events are reported for the Safety Analysis Set defined as all participants who received at least 1 dose of talimogene laherparepvec or atezolizumab.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) | Participants with TNBC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10^6 plaque-forming units/milliliter (PFU/mL) on Day 1 of Cycle 1 and 10^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle. | 6 | 11 | 4 | 10 | 8 | 10 |
| EG001 | Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) | Participants with CRC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10^6 PFU/mL on Day 1 of Cycle 1 and 10^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle. | 22 | 25 | 12 | 24 | 23 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Intra-abdominal fluid collection | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hepatic haematoma | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Colorectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Tumour hyperprogression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Ear congestion | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hepatic pain | Hepatobiliary disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
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| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
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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 | Nov 25, 2019 | May 13, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000629782 | talimogene laherparepvec |
| C000594389 | atezolizumab |
Not provided
Not provided
Not provided
| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Participants with CRC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10^6 PFU/mL on Day 1 of Cycle 1 and 10^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle. |
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Participants with CRC with liver metastases were administered intrahepatic injection of talimogene laherparepvec into liver metastases via guided injection (either ultrasound or computerized tomography) on Day 1 of each cycle for a maximum of 12 cycles, where each cycle was 21 days. Participants were administered 10^6 PFU/mL on Day 1 of Cycle 1 and 10^8 PFU/mL on Day 1 of each cycle thereafter. Participants were also administered 1200 mg atezolizumab via intravenous injection on Day 1 of each cycle.
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