Trial · NCT02509507
Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Tumors Alone and in Combination With Systemic Pembrolizumab MK-3475-611/Keynote-611
NCT02509507, Phase 1, Phase 2, Completed, Amgen; results first posted 2022-12-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Tumors Alone and in Combination With Systemic Pembrolizumab MK-3475-611/Keynote-611. Trials, record NCT02509507. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02509507
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Tumors Alone and in Combination With Systemic Pembrolizumab MK-3475-611/Keynote-611
- NCT number
- NCT02509507
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 127 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Hepatocellular Carcinoma, Liver Metastases, Cutaneous or Subcutaneous Lymph Node, Liver Tumors
- Interventions
- Talimogene Laherparepvec, Pembrolizumab
- First posted
- 2015-07-28
- Last updated
- 2024-08-06
- Other registries' IDs
- eudract:2014-005386-67
- Results first posted
- 2022-12-30
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Cycle 1 and Cycle 2: Day 1 to Day 21 | All toxicities were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03: * Grade 1: Mild * Grade 2: Moderate * Grade 3: Severe or medically significant but not immediately life threatening * Grade 4: Life threatening consequences * Grade 5: Death related to adverse event (AE) The occurrence of specific pre-defined toxicities during the DLT evaluation period were considered a DLT if judged by the investigator to be related to talimogene laherparepvec and/or pembrolizumab. All Grade 5 toxicities, intolerable toxicities that lead to permanent discontinuation of talimogene laherparepvec and/or pembrolizumab and Grade 3 or higher AEs related to talimogene laherparepvec and/or pembrolizumab that resulted in a study treatment delay by \> 2 weeks were considered DLTs. |
| Primary | Part 2 Only: Objective Response Rate (ORR) Per Modified Immune-related Response Criteria Simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST). | Up to 154 weeks | ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) per modified irRC-RECIST. * CR: 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: Decrease in tumor burden ≥ 30% relative to baseline confirmed by a consecutive assessment at least 4 weeks (28 days) after first documentation. |
| Primary | Part 2 Only: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | Day 1 to 30 days post-last dose of talimogene laherparepvec or pembrolizumab, whichever is later. The maximum duration of talimogene laherparepvec treatment was 102.4 weeks and pembrolizumab treatment was 109.3 weeks in Part 2. | A TEAE was defined as an event that emerged during treatment, having been absent pretreatment, or worsened relative to the pretreatment state. A treatment-related TEAE was defined as a TEAE that was suspected to be related to the study treatment. |
| Secondary | Part 1 Only: ORR Per Modified irRC-RECIST | Up to 297 weeks | ORR was defined as the percentage of participants with a best overall response of CR or PR per modified irRC-RECIST. * CR: 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: Decrease in tumor burden ≥ 30% relative to baseline confirmed by a consecutive assessment at least 4 weeks (28 days) after first documentation. |
| Secondary | Best Overall Response (BOR) Per Modified irRC-RECIST | Up to 297 weeks | BOR was defined as the number of participants with a best visit response in the following order: CR, PR, stable disease (SD), progressive disease (PD), or unevaluable (UE) as per modified irRC-RECIST. * CR: Disappearance of all lesions and confirmation by 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: Decrease in tumor burden ≥ 30% relative to baseline confirmed by a consecutive assessment at least 4 weeks (28 days) after first documentation. * SD: Neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. * PD: Increase in tumor burden ≥ 20 % and at least 5 mm absolute increase relative to nadir confirmation by a repeat, consecutive assessment no less than 4 weeks (28 days) from the date first documented PD. * UE: Any lesion present at baseline which was not assessed or was unable to be evaluated. |
| Secondary | Durable Response Rate (DRR) Per Modified irRC-RECIST | Up to 297 weeks | DRR per modified irRC-RECIST was defined as the percentage of participants with an objective response (CR/PR) with a duration of response of at least 6 months. * CR: Disappearance of all lesions and confirmation by 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: Decrease in tumor burden ≥ 30% relative to baseline confirmed by a consecutive assessment at least 4 weeks (28 days) after first documentation. |
| Secondary | Duration of Response (DOR) Per Modified irRC-RECIST | Up to 297 weeks | DOR per modified irRC-RECIST was defined as the time from the date of an initial response (CR/PR) that was subsequently confirmed to the earlier of PD or death. DOR was estimated using the Kaplan-Meier method. * CR: Disappearance of all lesions and confirmation by 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: Decrease in tumor burden ≥ 30% relative to baseline confirmed by a consecutive assessment at least 4 weeks (28 days) after first documentation. * PD: Increase in tumor burden ≥ 20 % and at least 5 mm absolute increase relative to nadir confirmation by a repeat, consecutive assessment no less than 4 weeks (28 days) from the date first documented PD. |
| Secondary | Disease Control Rate (DCR) Per Modified irRC-RECIST | Up to 297 weeks | DCR per modified irRC-RECIST was defined as percentage of participants that had a BOR in 1 of the following: CR, PR or SD. * CR: Disappearance of all lesions and confirmation by 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: Decrease in tumor burden ≥ 30% relative to baseline confirmed by a consecutive assessment at least 4 weeks (28 days) after first documentation. * SD: Neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. |
| Secondary | Progression Free Survival (PFS) Per Modified irRC-RECIST | Up to 297 weeks | PFS was defined as the time from first dose to the date of first of PD per modified irRC-RECIST criteria, or death, whichever occurs first. PFS was estimated using the Kaplan-Meier method. Participants that did not have an event of death or disease progression were censored at the latter of their last evaluable tumor assessment date or first dose date. * PD: Increase in tumor burden ≥ 20 % and at least 5 mm absolute increase relative to nadir confirmation by a repeat, consecutive assessment no less than 4 weeks (28 days) from the date first documented PD. |
| Secondary | Overall Survival (OS) | Up to 297 weeks | OS was defined as the time from the date of first dose date to the date of death from any cause. OS time was censored at the last date the participant was known to be alive when the confirmation of death was absent or unknown, or at the date 24 months after the last participant enrolled if the last known to be alive/death date was beyond it. One month = 365.25/12 days. OS was estimated using the Kaplan-Meier method. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Cycle 1 and Cycle 2: Day 1 to Day 21 | DLT Analysis Set: Participants who had at least 1 dose of planned monotherapy or combination treatment and had the opportunity to be on treatment for at least 6 weeks from the initial dosing of study treatment \& received at least 1 additional dose of monotherapy or combination or experienced a DLT during the DLT-evaluation period. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 2 Only: Objective Response Rate (ORR) Per Modified Immune-related Response Criteria Simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST). | Up to 154 weeks | Full Analysis Set (Part 2): Included all participants in Part 2 who received at least 1 dose of talimogene laherparepvec and at least 1 dose of pembrolizumab in combination. | percentage of participants | NUMBER |
| PRIMARY | Part 2 Only: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE) | Day 1 to 30 days post-last dose of talimogene laherparepvec or pembrolizumab, whichever is later. The maximum duration of talimogene laherparepvec treatment was 102.4 weeks and pembrolizumab treatment was 109.3 weeks in Part 2. | Safety Analysis Set (Part 2): Included all participants in Part 2 who have received at least 1 dose of talimogene laherparepvec or at least 1 dose of pembrolizumab. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1 Only: ORR Per Modified irRC-RECIST | Up to 297 weeks | Full Analysis Set (Part 1): Included all participants in Part 1 who received at least 1 dose of talimogene laherparepvec in monotherapy and combination cohorts and at least 1 dose of pembrolizumab in combination cohorts. | percentage of participants | NUMBER |
| SECONDARY | Best Overall Response (BOR) Per Modified irRC-RECIST | Up to 297 weeks | Full Analysis Set: Included all participants who received at least 1 dose of talimogene laherparepvec in monotherapy and combination cohorts and at least 1 dose of pembrolizumab in combination cohorts in Part 1 and Part 2. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Durable Response Rate (DRR) Per Modified irRC-RECIST | Up to 297 weeks | Full Analysis Set: Included all participants who received at least 1 dose of talimogene laherparepvec in monotherapy and combination cohorts and at least 1 dose of pembrolizumab in combination cohorts in Part 1 and Part 2. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) Per Modified irRC-RECIST | Up to 297 weeks | Full Analysis Set: Included all participants who received at least 1 dose of talimogene laherparepvec in monotherapy and combination cohorts and at least 1 dose of pembrolizumab in combination cohorts in Part 1 and Part 2. Only participants who had a BOR of CR/PR were included. | months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) Per Modified irRC-RECIST | Up to 297 weeks | Full Analysis Set: Included all participants who received at least 1 dose of talimogene laherparepvec in monotherapy and combination cohorts and at least 1 dose of pembrolizumab in combination cohorts in Part 1 and Part 2. | percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) Per Modified irRC-RECIST | Up to 297 weeks | Full Analysis Set: Included all participants who received at least 1 dose of talimogene laherparepvec in monotherapy and combination cohorts and at least 1 dose of pembrolizumab in combination cohorts in Part 1 and Part 2. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to 297 weeks | Full Analysis Set: Included all participants who received at least 1 dose of talimogene laherparepvec in monotherapy and combination cohorts and at least 1 dose of pembrolizumab in combination cohorts in Part 1 and Part 2. | months | MEDIAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group238
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Part 1: Monotherapy Group A | 2 | Participants | ||
| Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Part 1: Monotherapy Group B | 0 | Participants | ||
| Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Part 1: Combination Therapy Group A | 1 | Participants | ||
| Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Part 1: Combination Therapy Group B | 0 | Participants | ||
| Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Part 2: Hormone Receptor Positive Breast Cancer (HRBC) | 1 | Participants | ||
| Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Part 2: Triple Negative Breast Cancer (TNBC) | 0 | Participants | ||
| Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Part 2: Cutaneous Squamous Cell Carcinoma (CSCC) | 0 | Participants | ||
| Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Part 2: Basal Cell Carcinoma (BCC) | 0 | Participants | ||
| Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) | Part 2: Colorectal Adenocarcinoma (CRC) | 0 | Participants | ||
| Part 2 Only: Objective Response Rate (ORR) Per Modified Immune-related Response Criteria Simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST). | Part 2: Hormone Receptor Positive Breast Cancer (HRBC) | 10.0 | 95% Confidence Interval 0.3 to 44.5 | percentage of participants |
1 to 10 of 238Source ClinicalTrials.gov
See all 238 results by groupParticipant flow45
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1: Monotherapy Group A | 23 | |
| Overall Study | STARTED | Part 1: Monotherapy Group B | 5 | |
| Overall Study | STARTED | Part 1: Combination Therapy Group A | 24 | |
| Overall Study | STARTED | Part 1: Combination Therapy Group B | 22 | |
| Overall Study | STARTED | Part 2: Hormone Receptor Positive Breast Cancer (HRBC) | 10 | |
| Overall Study | STARTED | Part 2: Triple Negative Breast Cancer (TNBC) | 18 | |
| Overall Study | STARTED | Part 2: Cutaneous Squamous Cell Carcinoma (CSCC) | 10 | |
| Overall Study | STARTED | Part 2: Basal Cell Carcinoma (BCC) | 5 | |
| Overall Study | STARTED | Part 2: Colorectal Adenocarcinoma (CRC) | 10 | |
| Overall Study | Received Talimogene Laherparepvec | Part 1: Monotherapy Group A | 23 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 participant flowAdverse events2,052
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 | Part 1: Monotherapy Group A | 7 | 23 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: Monotherapy Group B | 0 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: Combination Therapy Group A | 6 | 24 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: Combination Therapy Group B | 3 | 22 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2: Hormone Receptor Positive Breast Cancer (HRBC) | 2 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2: Triple Negative Breast Cancer (TNBC) | 3 | 18 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2: Cutaneous Squamous Cell Carcinoma (CSCC) | 1 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2: Basal Cell Carcinoma (BCC) | 2 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2: Colorectal Adenocarcinoma (CRC) | 2 | 10 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Part 1: Monotherapy Group A | 0 | 23 |
1 to 10 of 2,052Source ClinicalTrials.gov
See all 2,052 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: Monotherapy Group A | 21 | 23 |
| Total, all-cause mortality | Part 1: Monotherapy Group B | 3 | 5 |
| Total, all-cause mortality | Part 1: Combination Therapy Group A | 22 | 24 |
| Total, all-cause mortality | Part 1: Combination Therapy Group B | 14 | 22 |
| Total, all-cause mortality | Part 2: Hormone Receptor Positive Breast Cancer (HRBC) | 8 | 10 |
| Total, all-cause mortality | Part 2: Triple Negative Breast Cancer (TNBC) | 13 | 18 |
| Total, all-cause mortality | Part 2: Cutaneous Squamous Cell Carcinoma (CSCC) | 5 | 10 |
| Total, all-cause mortality | Part 2: Basal Cell Carcinoma (BCC) | 4 | 5 |
| Total, all-cause mortality | Part 2: Colorectal Adenocarcinoma (CRC) | 8 | 10 |
| Total, other adverse events | Part 1: Monotherapy Group A | 23 | 23 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40156118 | DERIVED |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02509507
GET https://conductscience.org/api/trials/v1/NCT02509507/registered?page=2