A Phase 1 interventional study of Talimogene Laherparepvec and Atezolizumab in Metastatic Triple Negative Breast Cancer and Metastatic Colorectal Cancer, sponsored by Amgen. Completed at 17 sites in 6 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-05-14.
Sponsored by Amgen · Phase 1, Interventional, and Other
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Among 25 studies testing atezolizumab in Triple Negative Breast Neoplasms — 3 open to participants now, 8 under way, 1 of them phase 3. atezolizumab · Triple Negative Breast Neoplasms.
Among the 25 studies testing atezolizumab in Triple Negative Breast Neoplasms, this one is the 21st largest by enrollment, is one of 3 that started in 2018, is one of 3 in phase 1, and was the 10th registered.
1,219 studies on the registry are indexed under Triple Negative Breast Neoplasms; 445 are open to participants now.
Browse Triple Negative Breast Neoplasms studies →3 of the 25 studies testing atezolizumab in Triple Negative Breast Neoplasms are open now, in 3 countries. Recruiting first, the newest first:
European Institute of Oncology · Sites in Italy
Ages 18+
Peter MacCallum Cancer Centre, Australia · Sites in Australia
Ages 18–100
Dana-Farber Cancer Institute · Sites in United States
Ages 18+
By country, each count listing its studies:
atezolizumab: first FDA approval 2016 (TECENTRIQ), first EMA approval 2017. What it is approved for, and how studies give it, is on its page →
Of the 331 Triple Negative Breast Neoplasms studies recruiting now, 231 (70%) set no upper age limit and 85 (26%) stop at 75 or younger; 12 take children under 18; 6 take healthy volunteers.
This study: 18 Years to 99 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, atezolizumab is the treatment under test here. Read study by study →
25 studies; the count open now beside each. This study's row is marked.
First in 2015; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 36 is below the median of 60 across 1,053 interventional studies indexed under Triple Negative Breast Neoplasms.
Median enrollment 106 across the 25 interventional studies. Of the 16 that completed or were terminated, 12 (75%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 25 have an industry lead sponsor. The 10 most frequent:
Amgen is the lead sponsor of 1,047 studies on the registry; 51 are open to participants now.
Of its 246 completed or terminated interventional studies of FDA-regulated products, 166 (67%) have results posted.
Amgen has 2 studies filed under Triple Negative Breast Neoplasms — fewer than ten, so there is no comparison to draw.
3 of the studies testing atezolizumab in Triple Negative Breast Neoplasms that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06690840European Institute of OncologyAtezolizumab and Chemotherapy Treatment as T-cell Activators in Metastatic Triple Negative Breast Cancer Patients | 2026-12-15 |
| NCT04434040Dana-Farber Cancer InstituteAtezolizumab + Sacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA) | 2026-12-30 |
| NCT03756298National Cancer Center, KoreaEfficacy and Safety of Atezolizumab Plus Capecitabine Adjuvant Therapy for Triple Receptor-Negative Breast Cancer | 2026-12-31 |
Add all 3 to your calendar (.ics) → With an account.
Among the 25 studies testing atezolizumab in Triple Negative Breast Neoplasms, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: Talimogene Laherparepvec · Biological: Atezolizumab
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.
Biological: Talimogene Laherparepvec · Biological: Atezolizumab
Virally based anti-cancer immunotherapy given by direct injection into tumors.
Also known as: IMLYGIC
A monoclonal antibody given by intravenous injection.
Also known as: MPDL3280A
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: * Grade ≥ 4 neutropenia (absolute neutrophil count \[ANC\] \< 500/μl) lasting ≥ 7 days * Grade ≥ 3 febrile neutropenia * Grade ≥ 4 thrombocytopenia * Grade ≥ 4 anemia * Grade ≥ 4 rash * Serious herpetic events * Grade ≥ 3 symptomatic hepatic toxicities that do not resolve to Grade ≤ 2 within 48 hours or Grade ≥ 3 asymptomatic hepatic toxicities that do not resolve to Grade ≤ 1 within 3 weeks of onset * Grade ≥ 3 non-hematologic, non-hepatic organ toxicity * Grade 5 toxicity (ie, death) * Any other intolerable toxicity leading to permanent discontinuation of 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.
Time frame: From Day 1 up to the start of Cycle 3 (each cycle is 21 days)
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.
Time frame: Every 12 weeks (± 28 days) up to approximately 3.5 years.
Best Overall Response (BOR)
BOR was defined as the best visit response based on modified irRC-RECIST criteria: * CR: a complete disappearance of all lesions * PR: a decrease in tumor burden 30% or more relative to baseline * Stable disease (SD): neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for progressive disease (PD) * PD: an increase in tumor burden of 20% or more and at least 5 mm absolute increase relative to nadir (minimum recorded tumor burden) * Unevaluable (UE): any lesion present at baseline which was not assessed or was unable to be evaluated leading to an inability to determine the status of that particular tumor
Time frame: 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.
Time frame: 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: * Lesion complete response rate (L-CRR): Disappearance of lesion * Lesion partial response rate (L-PRR): Decrease in tumor burden 30% or more relative to baseline * Lesion objective response rate (L-ORR): Either a L-CRR or L-PRR based on modified irRC-RECIST criteria
Time frame: 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: * L-CRR: Disappearance of lesion * L-PRR: Decrease in tumor burden 30% or more relative to baseline * L-ORR: Either a L-CRR or L-PRR based on modified irRC-RECIST criteria
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Every 12 weeks (± 28 days) up to approximately 3.5 years.
Participants were enrolled at 15 research centers in Australia, Belgium, Germany, Spain, Switzerland and the United States.
| Milestone | Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) | Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) |
|---|---|---|
| Started | 11 | 25 |
| Received talimogene laherparepvec | 8 | 23 |
| Received atezolizumab | 10 | 24 |
| Safety analysis set | 10 | 24 |
| Completed | 1 | 0 |
| Not completed | 10 | 25 |
| Withdrew: Death | 6 | 22 |
| Withdrew: Withdrawal by subject | 3 | 3 |
| Withdrew: Sponsor decision | 1 | 0 |
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: * Grade ≥ 4 neutropenia (absolute neutrophil count \[ANC\] \< 500/μl) lasting ≥ 7 days * Grade ≥ 3 febrile neutropenia * Grade ≥ 4 thrombocytopenia * Grade ≥ 4 anemia * Grade ≥ 4 rash * Serious herpetic events * Grade ≥ 3 symptomatic hepatic toxicities that do not resolve to Grade ≤ 2 within 48 hours or Grade ≥ 3 asymptomatic hepatic toxicities that do not resolve to Grade ≤ 1 within 3 weeks of onset * Grade ≥ 3 non-hematologic, non-hepatic organ toxicity * Grade 5 toxicity (ie, death) * Any other intolerable toxicity leading to permanent discontinuation of 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.
| Participants | Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) | Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) |
|---|---|---|
| Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT) | 0 | 3 |
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.
| Percentage of Participants | Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) | Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) |
|---|---|---|
| Objective Response Rate (ORR) | 10.0 (0.3 to 44.5) | 0.0 (0.0 to 14.2) |
BOR was defined as the best visit response based on modified irRC-RECIST criteria: * CR: a complete disappearance of all lesions * PR: a decrease in tumor burden 30% or more relative to baseline * Stable disease (SD): neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for progressive disease (PD) * PD: an increase in tumor burden of 20% or more and at least 5 mm absolute increase relative to nadir (minimum recorded tumor burden) * Unevaluable (UE): any lesion present at baseline which was not assessed or was unable to be evaluated leading to an inability to determine the status of that particular tumor
| Participants | Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) | Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) |
|---|---|---|
| CR | 0 | 0 |
| PR | 1 | 0 |
| SD | 1 | 1 |
| PD | 3 | 4 |
| UE | 3 | 14 |
| Not done | 2 | 5 |
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.
| Months | Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) | Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) |
|---|---|---|
| Duration of Response (DOR) | NA (NA to NA) | — |
Responses for individual tumor lesions for hepatic and non-hepatic tumors injected wtih treatment were assessed for the following responses: * Lesion complete response rate (L-CRR): Disappearance of lesion * Lesion partial response rate (L-PRR): Decrease in tumor burden 30% or more relative to baseline * Lesion objective response rate (L-ORR): Either a L-CRR or L-PRR based on modified irRC-RECIST criteria
| Lesions | Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) | Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) |
|---|---|---|
| L-CRR - Hepatic | 0 (0.0 to 24.7) | 0 (0.0 to 12.3) |
| L-CRR - Overall | 0 (0.0 to 24.7) | 0 (0.0 to 12.3) |
| L-PRR - Hepatic | 1 (0.2 to 36.0) | 0 (0.0 to 12.3) |
| L-PRR - Overall | 1 (0.2 to 36.0) | 0 (0.0 to 12.3) |
| L-ORR - Hepatic | 1 (0.2 to 36.0) | 0 (0.0 to 12.3) |
| L-ORR - Overall | 1 (0.2 to 36.0) | 0 (0.0 to 12.3) |
Responses for individual tumor lesions for hepatic and non-hepatic tumors that were not injected with treatment were assessed for the following responses: * L-CRR: Disappearance of lesion * L-PRR: Decrease in tumor burden 30% or more relative to baseline * L-ORR: Either a L-CRR or L-PRR based on modified irRC-RECIST criteria
| Lesions | Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) | Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) |
|---|---|---|
| L-CRR - Hepatic | 0 (0.0 to 21.8) | 0 (0.0 to 7.1) |
| L-CRR - Non-hepatic | 0 (0.0 to 33.6) | 0 (0.0 to 8.0) |
| L-CRR - Overall | 0 (0.0 to 14.2) | 0 (0.0 to 3.8) |
| L-PRR - Hepatic | 0 (0.0 to 21.8) | 1 (0.1 to 10.6) |
| L-PRR - Non-hepatic | 1 (0.3 to 48.2) | 0 (0.0 to 8.0) |
| L-PRR - Overall | 1 (0.1 to 21.1) | 1 (0.0 to 5.8) |
| L-ORR - Hepatic | 0 (0.0 to 21.8) | 1 (0.1 to 10.6) |
| L-ORR - Non-hepatic | 1 (0.3 to 48.2) | 0 (0.0 to 8.0) |
| L-ORR - Overall | 1 (0.1 to 21.1) | 1 (0.0 to 5.8) |
DRR was defined as the percentage of participants with an objective response with a DOR of at least 6 months.
| Percentage of Participants | Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) | Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) |
|---|---|---|
| Durable Response Rate (DRR) | 0.0 (0.0 to 30.8) | 0.0 (0.0 to 14.2) |
DCR was defined as the percentage of participants that have a best overall response in one of the following categories: CR/PR/SD.
| Percentage of Participants | Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) | Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) |
|---|---|---|
| Disease Control Rate (DCR) | 20.0 (2.5 to 55.6) | 4.2 (0.1 to 21.1) |
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.
| Months | Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) | Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) |
|---|---|---|
| Progression-free Survival (PFS) | 5.4 (1.0 to NA) | 3.1 (2.1 to 5.2) |
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.
| Months | Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) | Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) |
|---|---|---|
| Overall Survival (OS) | 19.2 (1.5 to NA) | 4.0 (2.8 to 6.6) |
Collected over Day 1 up to approximately 3.5 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) | 6/11 (54.5%) | 4/10 (40%) | 8/10 (80%) |
| Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) | 22/25 (88%) | 12/24 (50%) | 23/24 (95.8%) |
| Event | Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) | Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) |
|---|---|---|
| PyrexiaGeneral disorders | 0/10 | 3/24 |
| Hepatic haematomaHepatobiliary disorders | 1/10 | 0/24 |
| Cytokine release syndromeImmune system disorders | 1/10 | 1/24 |
| HypersensitivityImmune system disorders | 1/10 | 0/24 |
| Abdominal infectionInfections and infestations | 1/10 | 0/24 |
| Orthostatic hypotensionVascular disorders | 1/10 | 0/24 |
| Cardiac failureCardiac disorders | 0/10 | 1/24 |
| MyocarditisCardiac disorders | 0/10 | 1/24 |
| Abdominal painGastrointestinal disorders | 0/10 | 1/24 |
| ConstipationGastrointestinal disorders | 0/10 | 1/24 |
| Event | Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) | Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) |
|---|---|---|
| PyrexiaGeneral disorders | 7/10 | 14/24 |
| ChillsGeneral disorders | 4/10 | 2/24 |
| FatigueGeneral disorders | 4/10 | 5/24 |
| VomitingGastrointestinal disorders | 2/10 | 8/24 |
| DiarrhoeaGastrointestinal disorders | 3/10 | 2/24 |
| NauseaGastrointestinal disorders | 3/10 | 5/24 |
| HeadacheNervous system disorders | 3/10 | 3/24 |
| TachycardiaCardiac disorders | 0/10 | 5/24 |
| Oedema peripheralGeneral disorders | 0/10 | 5/24 |
| Decreased appetiteMetabolism and nutrition disorders | 0/10 | 5/24 |
All enrolled participants.
| Age, Categorical(Participants) | Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) | Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 15 | 25 |
| >=65 years | 1 | 10 | 11 |
| Sex: Female, Male(Participants) | Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) | Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) | Total |
|---|---|---|---|
| Female | 11 | 12 | 23 |
| Male | 0 | 13 | 13 |
| Ethnicity (NIH/OMB)(Participants) | Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) | Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 11 | 24 | 35 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Talimogene Laherparepvec With Atezolizumab: Triple Negative Breast Cancer (TNBC) | Talimogene Laherparepvec With Atezolizumab: Colorectal Cancer (CRC) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 0 | 1 | 1 |
| White | 10 | 22 | 32 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: 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.
Access criteria: 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.
Data sharing details ↗ · www.amgen.com
Ran from Mar 2018 to primary completion in May 2020, 26 months.
Results were first posted in Jun 2021, 1 year after primary completion.
Of 135 industry-sponsored phase 1 interventional studies under Triple Negative Breast Neoplasms, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 70. This study's 26 months is below that.
Counting every sponsor, half of 208 studies reached it within 54 months; a quarter within 35 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Talimogene laherparepvec · Atezolizumab
Triple Negative Breast Neoplasms →