Trial · NCT02756845
Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors
NCT02756845, Phase 1, Completed, Amgen; results first posted 2024-02-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors. Trials, record NCT02756845. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02756845
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors
- NCT number
- NCT02756845
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 15 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Advanced Non CNS Tumors
- Interventions
- Talimogene Laherparepvec
- First posted
- 2016-04-29
- Last updated
- 2024-02-20
- Other registries' IDs
- eudract:2015-003645-25
- Results first posted
- 2024-02-05
- Limitations and caveats
- Participant recruitment ended when 15 participants were enrolled due to difficulties in enrollment.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Experienced a Dose-limiting Toxicity (DLT) | 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 |
| Secondary | Overall Response Rate (ORR) | Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months | 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. |
| Secondary | Duration of Response (DOR) | Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months | DOR was defined as the time from the date of an initial response of CR or PR to the earlier of PD/death. |
| Secondary | Time to Response (TTR) | Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months | 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. |
| Secondary | Time to Progression (TTP) | Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months | 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. |
| Secondary | Progression Free Survival (PFS) | Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months | 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. |
| Secondary | Overall Survival (OS) | Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Day 1 to Day 35 | DLT Analysis Set: all DLT evaluable participants defined as participants who had the opportunity to be followed for at least 35 days from the initial dosing of talimogene laherparepvec and received at least two treatments of talimogene laherparepvec (except participants who had a DLT after the first dose). | Percent of participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) | Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months | Safety Analysis Set: all participants who received at least one dose of talimogene laherparepvec. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) | Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months | Safety Analysis Set: all participants who received at least one dose of talimogene laherparepvec. | Days | MEDIAN |
| SECONDARY | Time to Response (TTR) | Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months | Safety Analysis Set: all participants who received at least one dose of talimogene laherparepvec. | Days | MEDIAN |
| SECONDARY | Time to Progression (TTP) | Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months | Safety analysis set: all participants who received at least one dose of talimogene laherparepvec. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months | Safety analysis set: all participants who received at least one dose of talimogene laherparepvec. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Every 12 weeks until the end of follow-up; maximum duration of follow-up was 54.51 months | Safety Analysis Set: all participants who received at least one dose of talimogene laherparepvec. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years | Experienced a DLT | 0.0 | 95% Confidence Interval 0.0 to 28.5 | Percent of participants |
| Percentage of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years | Experienced a DLT | 0.0 | 95% Confidence Interval 0.0 to 84.2 | Percent of participants |
| Percentage of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years | Did Not Experience a DLT | 100.0 | 95% Confidence Interval 71.5 to 100.0 | Percent of participants |
| Percentage of Participants Who Experienced a Dose-limiting Toxicity (DLT) | Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years | Did Not Experience a DLT | 100.0 | 95% Confidence Interval 15.8 to 100.0 | Percent of participants |
| Overall Response Rate (ORR) | Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years | 0.0 | 95% Confidence Interval 0.00 to 24.71 | Percentage of participants | |
| Overall Response Rate (ORR) | Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years | 0.0 | 95% Confidence Interval 0.00 to 84.19 | Percentage of participants | |
| Duration of Response (DOR) | Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years | NA | Full Range NA to NA | Days | |
| Duration of Response (DOR) | Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years | NA | Full Range NA to NA | Days | |
| Time to Response (TTR) | Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years | NA | Full Range NA to NA | Days | |
| Time to Response (TTR) | Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years | NA | Full Range NA to NA | Days |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years | 13 | |
| Overall Study | STARTED | Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years | 2 | |
| Overall Study | Received Talimogene Laherparepvec | Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years | 13 | |
| Overall Study | Received Talimogene Laherparepvec | Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years | 2 | |
| Overall Study | COMPLETED | Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years | 0 | |
| Overall Study | COMPLETED | Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years | 0 | |
| Overall Study | NOT COMPLETED | Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years | 13 | |
| Overall Study | NOT COMPLETED | Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years | 2 |
Source ClinicalTrials.gov
Adverse events160
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years | 3 | 13 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years | 0 | 2 | |
| other | Coagulopathy | Blood and lymphatic system disorders | Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years | 1 | 13 | |
| other | Coagulopathy | Blood and lymphatic system disorders | Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years | 0 | 2 | |
| other | Sinus tachycardia | Cardiac disorders | Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years | 2 | 13 | |
| other | Sinus tachycardia | Cardiac disorders | Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years | 0 | 2 | |
| other | Tachycardia | Cardiac disorders | Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years | 1 | 13 | |
| other | Tachycardia | Cardiac disorders | Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years | 0 | 2 | |
| other | Autoimmune hypothyroidism | Endocrine disorders | Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years | 1 | 13 | |
| other | Autoimmune hypothyroidism | Endocrine disorders | Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years | 0 | 2 |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years | 12 | 13 |
| Total, all-cause mortality | Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years | 2 | 2 |
| Total, other adverse events | Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years | 13 | 13 |
| Total, other adverse events | Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years | 2 | 2 |
| Total, serious adverse events | Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years | 5 | 13 |
| Total, serious adverse events | Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years | 1 | 2 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37292376 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years vs Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years: deaths from any cause | Trial comparisons |
| Cohort A1: Talimogene Laherparepvec (TVEC) - Aged 12 to ≤ 21 Years vs Cohort B1: Talimogene Laherparepvec (TVEC) - Aged 2 to < 12 Years: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02756845
GET https://conductscience.org/api/trials/v1/NCT02756845/events?page=2