Advanced Non CNS TumorsPhase 1NCT02756845
Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors
A Phase 1 study testing Talimogene Laherparepvec in people with Advanced Non CNS Tumors, run by Amgen at 22 sites in 7 countries.
Trial summary
This is a phase 1 study to evaluate the safety of intralesional talimogene laherparepvec administration in pediatric subjects with advanced non-CNS tumors that are amenable to direct injection Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- Advanced Non CNS Tumors
- What is being tested?
- Talimogene Laherparepvec
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 22 sitesin 7 countries
- Study dates
- 16 Aug 2017to 29 Nov 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subject's legally acceptable representative has provided informed consent/assent when the subject is legally too young to provide informed consent/assent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
- Should be willing to submit local HSV-1 serostatus within 28 days prior to enrollment.
- Subject must be a candidate for intralesional injection, defined as one or more of the following:
- at least 1 injectable lesion ≥ 10 mm in longest diameter
- multiple injectable lesions that in aggregate have a longest diameter of ≥ 10 mm
- Life expectancy > 4 months from the date of enrollment.
Show all 46Show fewer
- Male or female subjects 2 to ≤ 21 years of age at the time of informed consent/assent.
- Histologically or cytologically confirmed non-CNS solid tumor that recurred after standard/frontline therapy, or for which there is no standard/frontline therapy available.
- Presence of measurable or non-measurable lesions as defined by irRC-RECIST
- Performance status as per protocol
- Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to dosing.
- Adequate organ function as defined in protocol
- •Exclusion Criteria
- Diagnosis of leukemia, non-Hodgkin's lymphoma, Hodgkin's disease, or other hematologic malignancy.
- Radiotherapy to the bone marrow within 6 weeks prior to enrollment OR within 3 months prior to enrollment if prior radiotherapy to the craniospinal axis or to at least 60% of the pelvis was received; within 2 weeks prior to enrollment if local palliative radiotherapy was received.
- Primary ocular or mucosal melanoma.
- History of other malignancy within the past 5 years with the following exception:
- malignancy treated with curative intent and with no known active disease present and has not received chemotherapy for > 5 years before enrolment and felt to be at low risk for recurrence by the treating physician.
- History or evidence of active autoimmune disease that requires systemic treatment (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Active herpetic skin lesions or prior complications of herpetic infection (eg, herpetic keratitis or encephalitis).
- Prior treatment with talimogene laherparepvec or any other oncolytic virus.
- Prior treatment with a tumor vaccine.
- Requires intermittent or chronic treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use.
- Expected to require other cancer therapy while on study with the exception of local palliative radiation treatment.
- Has acute or chronic active hepatitis B virus or hepatitis C virus infection or received treatment with nucleotide analogs such as those used in the treatment of hepatitis B virus (eg, lamivudine, adefovir, tenofovir, telbivudine, and entecavir), ribavirin, or interferon alpha within 12 weeks of initiation of study treatment.
- Known or suspected human immunodeficiency virus (HIV) infection.
- Received live vaccine within 28 days prior to enrollment.
- No antiplatelet or anticoagulation medications allowed within 7 days prior totalimogene laherparepvec injection except low-dose heparin needed to maintain venous catheter patency.
- Female subject is pregnant or breast-feeding, or planning to become pregnant during study treatment and through 3 months after the last dose of talimogene laherparepvec.
- Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 3 months after the last dose of talimogene laherparepvec. Note: Acceptable methods of effective contraception are defined in the informed consent/assent form. Where required by local laws and regulations, additional country-specific contraception requirements may be outlined in a country-specific protocol supplement at the end of the Appendix Section of protocol.
- Subject has known sensitivity to any of the products or components to be administered during dosing.
- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge.
- History or evidence of any psychiatric disorder, substance abuse or any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- Subject who is unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for HSV-1 induced complications (immunosuppressed individuals, HIV-positive individuals, pregnant women, or children under the age of 1 year) during talimogene laherparepvec treatment and through 28 days after the last dose of talimogene laherparepvec.
- Evidence of clinically significant immunosuppression such as the following:
- primary immunodeficiency state such as severe combined immunodeficiency disease
- concurrent opportunistic infection
- receiving systemic immunosuppressive therapy (> 2 weeks prior to enrollment), including oral steroid doses (with the exception of maintenance physiologic replacement). Subjects who require intermittent use of steroids for inhalation or local steroid injection will not be excluded from the study
- less than 6 months from autologous bone marrow transplant or stem cell infusion
- history of allogeneic bone marrow transplant
- History or evidence of xeroderma pigmentosum.
- Sexually active subjects and their partners unwilling to use a male or female latex condom to avoid potential viral transmission during sexual contact while on treatment and within 30 days after treatment with talimogene laherparepvec. For those with latex allergies, polyurethane condoms may be used.
- Prior chemotherapy, treatment dose radiotherapy, or biological cancer therapy within 14 days prior to enrollment or has not recovered to Common Terminology Criteria for Adverse Events version 4.0 (CTCAE) grade 1 or better from adverse event due to cancer therapy administered more than 14 days prior to enrollment.
- CNS tumor or clinically active brain metastases (patient with a history of treated brain metastases are eligible if there is radiographic evidence of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study).
- Currently receiving treatment in another investigational device or drug study, or less than 14 days since ending treatment on another investigational device or drug study(ies) or has not recovered to CTCAE version 4.0 grade 1 or better from adverse event due to other investigational device or drug study administered more than 14 days prior to enrollment. Other investigational procedures while participating in this study are excluded.
- Major surgery ≤ 14 days prior to enrollment or has not recovered to CTCAE version 4.0 grade 1 or better from adverse event due to surgery performed more than 14 days prior to enrollment.
Who cannot join
None listed.
Trial locations and contacts
22 sites in 7 countries.
22 sites in 7 countries
United States9 sites
Ann and Robert H Lurie Childrens Hospital of Chicago
Chicago, Illinois, 60611
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
Nationwide Childrens Hospital
Columbus, Ohio, 43205
Childrens Hospital of Michigan
Detroit, Michigan, 48201
Riley Hospital for Children
Indianapolis, Indiana, 46202
Nemours du Pont Hospital in Florida
Jacksonville, Florida, 32207
Columbia University Medical Center
New York, New York, 10032
Childrens Hospital of Philidelphia
Philadelphia, Pennsylvania, 19104
AI Dupont Hospital for Children
Wilmington, Delaware, 19803
Spain5 sites
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035
Hospital Sant Joan de Deu
Esplugues de Llobregat, Catalonia, 08950
Hospital Universitario Infantil Niño Jesus
Madrid, 28009
Hospital Universitario Virgen del Rocio
Seville, Andalusia, 41013
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, 46026
France3 sites
Institut Hematologie et Oncologie Pediatrique
Lyon, 69373
Centre Hospitalier Universitaire de Marseille - Hopital de la Timone
Marseille, 13385
Institut Curie
Paris, 75005
Switzerland2 sites
Universitaets-Kinderspital beider Basel
Basel, 4031
Universitaets-Kinderspital
Zurich, 8032
Canada1 site
Centre Hospitalier Universitaire Sainte Justine
Montreal, Quebec, H3T 1C5
About this study
Official title: A Phase 1, Multi-center, Open-label, Dose De-escalation Study to Evaluate the Safety and Efficacy of Talimogene Laherparepvec in Pediatric Subjects With Advanced Non Central Nervous System Tumors That Are Amenable to Direct Injection
This is a phase 1 study to evaluate the safety of intralesional talimogene laherparepvec administration in pediatric subjects with advanced non-CNS tumors that are amenable to direct injection
Read the detailed description
This is a phase 1, multicenter, open-label study of talimogene laherparepvec in pediatric subjects with advanced non-CNS tumors that are amenable to direct injection in the clinical setting. Approximately 18 - 24 pediatric subjects are expected to be enrolled and treated with at least 1 dose of talimogene laherparepvec into 2 cohorts stratified by age. DLT will be evaluated based on at least 9 DLT-evaluable subjects in cohort A1. The DLT evaluation period is 35 days from the initial administration of talimogene laherparepvec.
- Conditions
- Advanced Non CNS Tumors
- Being tested
- Talimogene Laherparepvec
- Keywords
- Non CNS Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talimogene LaherparepvecDrug
Also called TVEC
Talimogene laherparepvec will be administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance. The first dose of talimogene laherparepvec will be up to 4.0 mL of 10^6 PFU/mL administered on day 1. The second injection, up to 4.0 mL of 10^8 PFU/mL (or up to 4.0 mL of 10^6 PFU/mL for a dose de-escalated cohort), will be administered 21 (+3) days after the initial injection. All subsequent injections, up to 4.0 mL of 10^8 PFU/mL (or up to 4.0 mL of 10^6 PFU/mL for a dose de-escalated cohort), will be administered every 14 (± 3) days. The treatment cycle interval may be increased due to toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Talimogene Laherparepvec (TVEC) | Experimental | The first dose of talimogene laherparepvec will be administered at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (+3 days) later. Subsequent doses of up to 4.0 mL of 10ᶺ8 PFU/mL will be administered every 14 days (± 3 days) thereafter. Cohorts will be assigned as follows: Cohort A1 (age 12 to ≤ 21 years). Cohort B1 (age 2 to < 12 years). The DLRT will review the safety data of the first 3 subjects in the older age cohort A1 to decide if the younger age cohort B1 can be opened for enrollment. If dose de-escalation is needed and if permissible based on the incidence of DLTs, additional DLT-evaluable subjects will be enrolled and treated at a lower dose level of talimogene laherparepvec. Dose de-escalation cohorts will be assigned as follows and the same DLT rules will be applied: Cohort A2 (age 12 to ≤ 21 years), Cohort B2 (age 2 to < 12 years). Receives: Drug: Talimogene Laherparepvec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Experienced a Dose-limiting Toxicity (DLT)
All toxicities were graded using the Common Terminology Criteria for Adverse Events version 4.0:
- Grade 1: Mild
- Grade 2: Moderate
- Grade 3: Severe/medically significant but not immediately life-threatening
- Grade 4: Life-threatening
- Grade 5: Death related to adverse event
The occurrence of any of the below was considered a DLT, if judged to be related to talimogene laherparepvec:
- Grade 4 non-hematologic toxicity
- Grade 3 non-hematologic toxicity that lasted > 3 days despite optimal supportive care
- Any ≥ grade 3 non-hematologic laboratory value if medical intervention was required, the abnormality led to hospitalization or the abnormality persisted for > 1 week unless deemed not clinically important per both investigator \& sponsor
- Febrile neutropenia grade 3/4
- Thrombocytopenia < 25 x 10^9/L associated with bleeding event that required intervention
- Serious herpetic event
- Grade 5 toxicity
- Any intolerable toxicity that led to permanent discontinuation of talimogene laherparepvec
Measured: Day 1 to Day 35
Secondary outcomes (6)
Overall Response Rate (ORR)
ORR was defined as the percentage of participants who experienced either complete response (CR) or partial response (PR) per modified immune-related response criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST) response criteria.
CR was defined as the 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 was defined as the decrease in tumor burdena ≥ 30% relative to baseline confirmed by a consecutive assessment at least 4 weeks (28 days) after first documentation.
Measured: Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months
Duration of Response (DOR)
DOR was defined as the time from the date of an initial response of CR or PR to the earlier of PD/death.
Measured: Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months
Time to Response (TTR)
TTR was defined as the number of days from the first dose of talimogene laherparepvec to the first objective assessment of response as per modified irRC-RECIST.
Measured: Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months
Time to Progression (TTP)
TTP was defined as the time from the first dose of talimogene laherparepvec until objective tumor progression per irRC-RECIST.
TTP was estimated using the Kaplan-Meier method.
Measured: Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months
Progression Free Survival (PFS)
PFS was defined as the time from the first dose to the earlier of disease progression per modified irRC-RECIST or death from any cause.
PFS was estimated using the Kaplan-Meier method.
Measured: Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months
Overall Survival (OS)
OS was defined as as the time from first dose to the event of death from any cause.
OS was estimated using the Kaplan-Meier method.
Measured: Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study start16 Aug 2017
- Primary completion17 Jan 2022
- Study completion29 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Non CNS TumorsStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Approximately 18 to 24 treated pediatric subjects are expected to be enrolled into 2 cohorts stratified by age (permissible based on the incidence of DLTs, a minimum of 6 subjects/cohort and a minimum of 18 subjects total). * Cohort A1 (12 to ≤ 21 years of age) * Cohort B1 (2 to \< 12 years of age) Initially, 3 subjects 12 to ≤ 21 years of age are to be enrolled and treated at 100% of the recommended adult dose regimen of talimogene laherparepvec (cohort A1). The dose level review team (DLRT) will review the safety data of the first 3 subjects in the older age cohort A1 to decide if the younger age cohort B1 can be opened for enrollment. If a DLT occurs in the first 3 DLT-evaluable subjects in the older age cohort (A1 or A2), the younger age cohort will not open until a DLT rate \< 33% is observed with at least 6 DLT-evaluable subjects in the older age cohort (A1 or A2).
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756845
- Sponsor's protocol ID
- 20110261
- Other IDs
- 2015-003645-25, 2015
- Status last verified
- Feb 2024
- First submitted
- 15 Dec 2015
- Last updated
- 20 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Publications
Moreno L, Teira P, Croop JM, Gerber NU, Andre N, Aerts I, Gros Subias L, De Wilde B, Bautista F, Turpin B, Kunduri S, Hamidi A, Lawrence T, Streby KA. A phase 1, first-in-child, multicenter study to evaluate the safety and efficacy of the oncolytic herpes virus talimogene laherparepvec in pediatric patients with advanced solid tumors. Front Pediatr. 2023 May 24;11:1183295. doi: 10.3389/fped.2023.1183295. eCollection 2023.
PubMed 37292376
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multi-center, Open-label, Dose De-escalation Study to Evaluate the Safety and Efficacy of Talimogene Laherparepvec in Pediatric Subjects With Advanced Non Central Nervous System Tumors That Are Amenable to Direct Injection
- ClinicalTrials.gov ID
- NCT02756845
- Acronym / sponsor ID
- 20110261
- Conditions
- Advanced Non CNS Tumors
- Keywords
- Non CNS Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- 17 Jan 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Posted 5 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1 study to evaluate the safety of intralesional talimogene laherparepvec administration in pediatric subjects with advanced non-CNS tumors that are amenable to direct injection
Detailed description
This is a phase 1, multicenter, open-label study of talimogene laherparepvec in pediatric subjects with advanced non-CNS tumors that are amenable to direct injection in the clinical setting. Approximately 18 - 24 pediatric subjects are expected to be enrolled and treated with at least 1 dose of talimogene laherparepvec into 2 cohorts stratified by age. DLT will be evaluated based on at least 9 DLT-evaluable subjects in cohort A1. The DLT evaluation period is 35 days from the initial administration of talimogene laherparepvec.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Approximately 18 to 24 treated pediatric subjects are expected to be enrolled into 2 cohorts stratified by age (permissible based on the incidence of DLTs, a minimum of 6 subjects/cohort and a minimum of 18 subjects total). * Cohort A1 (12 to ≤ 21 years of age) * Cohort B1 (2 to < 12 years of age) Initially, 3 subjects 12 to ≤ 21 years of age are to be enrolled and treated at 100% of the recommended adult dose regimen of talimogene laherparepvec (cohort A1). The dose level review team (DLRT) will review the safety data of the first 3 subjects in the older age cohort A1 to decide if the younger age cohort B1 can be opened for enrollment. If a DLT occurs in the first 3 DLT-evaluable subjects in the older age cohort (A1 or A2), the younger age cohort will not open until a DLT rate < 33% is observed with at least 6 DLT-evaluable subjects in the older age cohort (A1 or A2).
| Arm | Type | Receives |
|---|---|---|
| Talimogene Laherparepvec (TVEC) | Experimental | Drug: Talimogene LaherparepvecThe first dose of talimogene laherparepvec will be administered at a dose of up to 4.0 mL of 10ᶺ6 PFU/mL followed by a dose of up to 4.0 mL of 10ᶺ8 PFU/mL 21 days (+3 days) later. Subsequent doses of up to 4.0 mL of 10ᶺ8 PFU/mL will be administered every 14 days (± 3 days) thereafter. Cohorts will be assigned as follows: Cohort A1 (age 12 to ≤ 21 years). Cohort B1 (age 2 to < 12 years). The DLRT will review the safety data of the first 3 subjects in the older age cohort A1 to decide if the younger age cohort B1 can be opened for enrollment. If dose de-escalation is needed and if permissible based on the incidence of DLTs, additional DLT-evaluable subjects will be enrolled and treated at a lower dose level of talimogene laherparepvec. Dose de-escalation cohorts will be assigned as follows and the same DLT rules will be applied: Cohort A2 (age 12 to ≤ 21 years), Cohort B2 (age 2 to < 12 years). |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (46 listed)
- Subject's legally acceptable representative has provided informed consent/assent when the subject is legally too young to provide informed consent/assent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated.
- Should be willing to submit local HSV-1 serostatus within 28 days prior to enrollment.
- Subject must be a candidate for intralesional injection, defined as one or more of the following:
- Life expectancy > 4 months from the date of enrollment.
- Male or female subjects 2 to ≤ 21 years of age at the time of informed consent/assent.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Talimogene LaherparepvecAlso: TVECTalimogene laherparepvec will be administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance. The first dose of talimogene laherparepvec will be up to 4.0 mL of 10^6 PFU/mL administered on day 1. The second injection, up to 4.0 mL of 10^8 PFU/mL (or up to 4.0 mL of 10^6 PFU/mL for a dose de-escalated cohort), will be administered 21 (+3) days after the initial injection. All subsequent injections, up to 4.0 mL of 10^8 PFU/mL (or up to 4.0 mL of 10^6 PFU/mL for a dose de-escalated cohort), will be administered every 14 (± 3) days. The treatment cycle interval may be increased due to toxicity. | Drug | Talimogene Laherparepvec (TVEC) |
Primary outcome
Percentage of Participants Who Experienced a Dose-limiting Toxicity (DLT)
Time frame: Day 1 to Day 35
All toxicities were graded using the Common Terminology Criteria for Adverse Events version 4.0: * Grade 1: Mild * Grade 2: Moderate * Grade 3: Severe/medically significant but not immediately life-threatening * Grade 4: Life-threatening * Grade 5: Death related to adverse event The occurrence of any of the below was considered a DLT, if judged to be related to talimogene laherparepvec: * Grade 4 non-hematologic toxicity * Grade 3 non-hematologic toxicity that lasted > 3 days despite optimal supportive care * Any ≥ grade 3 non-hematologic laboratory value if medical intervention was required, the abnormality led to hospitalization or the abnormality persisted for > 1 week unless deemed not clinically important per both investigator \& sponsor * Febrile neutropenia grade 3/4 * Thrombocytopenia < 25 x 10^9/L associated with bleeding event that required intervention * Serious herpetic event * Grade 5 toxicity * Any intolerable toxicity that led to permanent discontinuation of talimogene laherparepvec
6 secondary outcomes
Overall Response Rate (ORR)
Time frame: Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months
Duration of Response (DOR)
Time frame: Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months
Time to Response (TTR)
Time frame: Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months
Time to Progression (TTP)
Time frame: Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months
Progression Free Survival (PFS)
Time frame: Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months
Overall Survival (OS)
Time frame: Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37292376Moreno L, Teira P, Croop JM, Gerber NU, Andre N, Aerts I, Gros Subias L, De Wilde B, Bautista F, Turpin B, Kunduri S, Hamidi A, Lawrence T, Streby KA. A phase 1, first-in-child, multicenter study to evaluate the safety and efficacy of the oncolytic herpes virus talimogene laherparepvec in pediatric patients with advanced solid tumors. Front Pediatr. 2023 May 24;11:1183295. doi: 10.3389/fped.2023.1183295. eCollection 2023.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
22 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Talimogene Laherparepvec in people with Advanced Non CNS Tumors, run by Amgen at 22 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 46 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Spain, France, Switzerland, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Experienced a Dose-limiting Toxicity (DLT) (time frame: Day 1 to Day 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02756845, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.