Trial · NCT00769704
Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma
NCT00769704, Phase 3, Completed, BioVex Limited; results first posted 2015-12-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma. Trials, record NCT00769704. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00769704
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma
- NCT number
- NCT00769704
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 437 participants, actual
- Lead sponsor
- BioVex Limited
- Conditions
- Melanoma
- Interventions
- Talimogene laherparepvec, GM-CSF
- First posted
- 2008-10-09
- Last updated
- 2016-07-13
- Other registries' IDs
- eudract:2008-006140-20
- Results first posted
- 2015-12-17
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Durable Response Rate | From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months. | Durable response rate was defined as the percentage of participants with a complete response (CR) or partial response (PR) maintained continuously for at least 6 months from the time the objective response was first observed and initiating within 12 months of starting therapy as assessed by the Endpoint Assessment Committee (EAC). This reflects all new sites of disease as well as disease sites identified at baseline. Disease assessments were performed at the beginning of each treatment cycle in accordance with modified World Health Organization criteria. CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline. |
| Secondary | Overall Survival | From randomization until the first 290 survival events had occurred (data cut-off date of 31 March 2014); median time on follow-up was 44 months. | Overall survival was defined as the time from the date of randomization to the date of death from any cause. Overall survival time was censored at the last date the patient was known to be alive when the confirmation of death was absent or unknown. Participants were censored at the date of randomization if no additional follow-up data were obtained. |
| Secondary | Objective Response Rate | From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months. | Objective response rate was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) assessed by the Endpoint Assessment Committee (EAC). Best overall response for a patient is the best overall response observed across all time points. Disease assessments were performed at the beginning of each treatment cycle and assessed in accordance with modified World Health Organization criteria. CR: Disappearance of all clinical evidence of tumor (both measurable and non-measurable but evaluable disease); PR: ≥ 50% reduction in the sum of the products of the perpendicular diameters of all measurable tumors at the time of assessment as compared to baseline. |
| Secondary | Duration of Response | From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months. | The duration of response is defined as the longest individual period from entering response (CR or PR as assessed by the EAC) to the first documented evidence of the patient no longer meeting the criteria for being in response or death, whichever is earlier. Responses were censored at the last assessment showing response. |
| Secondary | Response Onset | From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months. | Response onset is defined as the time from the date of randomization to the date of the first documented evidence of response (CR or PR) per EAC assessment. |
| Secondary | Time to Treatment Failure | From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months. | Time to treatment failure was assessed by the investigator, and calculated from randomization until the first clinically relevant disease progression where there is no response achieved after the progression, or until death if no such progression occurs. Participants who did not have clinically relevant progression or did not die were censored at the time of the their last tumor assessment. Participants who withdrew from treatment due to a clinically unacceptable toxicity were not considered as an event in the analysis. Progressive disease (PD) is defined as a ≥ 25% increase in the sum of the products of the perpendicular diameters of all measurable tumors since baseline, or the unequivocal appearance of a new tumor since the last response assessment time point. Clinically relevant progressive disease is PD that is associated with a decline in performance status and/or in the opinion of the investigator the patient requires alternative therapy. |
| Secondary | Response Interval | From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months. | Response interval is defined as the interval between the date of randomization and the date of the last documented evidence of response (CR or PR as assessed by the Investigator) prior to any new anti-cancer therapy. Response Interval post response onset was censored if a patient was still in response at the last observation. |
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 | Durable Response Rate | From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months. | Intent-to-treat population (all participants randomized to receive study treatment), excluding one participant who was randomized three times. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival | From randomization until the first 290 survival events had occurred (data cut-off date of 31 March 2014); median time on follow-up was 44 months. | Intent-to-treat population | months | MEDIAN |
| SECONDARY | Objective Response Rate | From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months. | Intent-to-treat population | percentage of participants | NUMBER |
| SECONDARY | Duration of Response | From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months. | Participants with an objective response (CR or PR) per EAC assessment. | months | MEDIAN |
| SECONDARY | Response Onset | From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months. | Participants with an objective response (CR or PR) per EAC assessment. | months | MEDIAN |
| SECONDARY | Time to Treatment Failure | From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months. | Intent to treat population | months | MEDIAN |
| SECONDARY | Response Interval | From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months. | Participants with an objective response (CR or PR) per Investigator assessment. | months | MEDIAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Durable Response Rate | GM-CSF | 2.1 | 95% Confidence Interval 0.0 to 4.5 | percentage of participants | |
| Durable Response Rate | Talimogene Laherparepvec | 16.3 | 95% Confidence Interval 12.1 to 20.5 | percentage of participants | |
| Overall Survival | GM-CSF | 18.9 | 95% Confidence Interval 16.0 to 23.7 | months | |
| Overall Survival | Talimogene Laherparepvec | 23.3 | 95% Confidence Interval 19.5 to 29.6 | months | |
| Objective Response Rate | GM-CSF | 5.7 | 95% Confidence Interval 1.9 to 9.5 | percentage of participants | |
| Objective Response Rate | Talimogene Laherparepvec | 26.4 | 95% Confidence Interval 21.4 to 31.5 | percentage of participants | |
| Duration of Response | GM-CSF | 2.8 | 95% Confidence Interval 1.2 to NA | months | |
| Duration of Response | Talimogene Laherparepvec | NA | 95% Confidence Interval NA to NA | months | |
| Response Onset | GM-CSF | 3.7 | 95% Confidence Interval 1.9 to 5.6 | months | |
| Response Onset | Talimogene Laherparepvec | 4.1 | 95% Confidence Interval 3.8 to 5.4 | months |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GM-CSF | 141 | |
| Overall Study | STARTED | Talimogene Laherparepvec | 296 | |
| Overall Study | Intent-to-treat Population | GM-CSF | 141 | |
| Overall Study | Intent-to-treat Population | Talimogene Laherparepvec | 295 | |
| Overall Study | Received Treatment | GM-CSF | 127 | |
| Overall Study | Received Treatment | Talimogene Laherparepvec | 292 | |
| Overall Study | COMPLETED | GM-CSF | 30 | |
| Overall Study | COMPLETED | Talimogene Laherparepvec | 97 | |
| Overall Study | NOT COMPLETED | GM-CSF | 111 | |
| Overall Study | NOT COMPLETED | Talimogene Laherparepvec | 199 |
Source ClinicalTrials.gov
Adverse events284
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 | GM-CSF | 2 | 127 | |
| other | Anaemia | Blood and lymphatic system disorders | Talimogene Laherparepvec | 15 | 292 | |
| other | Abdominal pain | Gastrointestinal disorders | GM-CSF | 3 | 127 | |
| other | Abdominal pain | Gastrointestinal disorders | Talimogene Laherparepvec | 26 | 292 | |
| other | Constipation | Gastrointestinal disorders | GM-CSF | 8 | 127 | |
| other | Constipation | Gastrointestinal disorders | Talimogene Laherparepvec | 34 | 292 | |
| other | Diarrhoea | Gastrointestinal disorders | GM-CSF | 14 | 127 | |
| other | Diarrhoea | Gastrointestinal disorders | Talimogene Laherparepvec | 55 | 292 | |
| other | Dyspepsia | Gastrointestinal disorders | GM-CSF | 8 | 127 | |
| other | Dyspepsia | Gastrointestinal disorders | Talimogene Laherparepvec | 15 | 292 |
1 to 10 of 284Source ClinicalTrials.gov
See all 284 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GM-CSF | ||
| Total, all-cause mortality | Talimogene Laherparepvec | ||
| Total, other adverse events | GM-CSF | 112 | 127 |
| Total, other adverse events | Talimogene Laherparepvec | 282 | 292 |
| Total, serious adverse events | GM-CSF | 17 | 127 |
| Total, serious adverse events | Talimogene Laherparepvec | 75 | 292 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| GM-CSF vs Talimogene Laherparepvec: serious adverse events |
Source 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/NCT00769704
GET https://conductscience.org/api/trials/v1/NCT00769704/events?page=2