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| ID | Type | Description | Link |
|---|---|---|---|
| 20110263 | Other Identifier | Sponsor | |
| 2008-006140-20 | EudraCT Number |
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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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The objective of this study is to evaluate the efficacy and safety of treatment with talimogene laherparepvec compared to subcutaneously administered GM-CSF in patients with unresectable Stage IIIb, IIIc and Stage IV melanoma. The efficacy endpoints of the study aim to demonstrate overall clinical benefit for patients treated with talimogene laherparepvec as compared to GM-CSF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GM-CSF | Active Comparator | Granulocyte macrophage colony-stimulating factor (GM-CSF) was administered at a dose of 125 μg/m²/day subcutaneously for 14 days, followed by a 14-day rest period for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months. |
|
| Talimogene Laherparepvec | Experimental | Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose of talimogene laherparepvec was at a concentration of 10⁶ plaque forming units (PFU)/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talimogene laherparepvec | Biological | Up to 4 mL of 10⁸ pfu/mL/per intratumoral injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Durable Response Rate | 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. | From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Cancer Center | Tucson | Arizona | 85724 | United States | ||
| University of Arkansas for Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26014293 | Result | Andtbacka RH, Kaufman HL, Collichio F, Amatruda T, Senzer N, Chesney J, Delman KA, Spitler LE, Puzanov I, Agarwala SS, Milhem M, Cranmer L, Curti B, Lewis K, Ross M, Guthrie T, Linette GP, Daniels GA, Harrington K, Middleton MR, Miller WH Jr, Zager JS, Ye Y, Yao B, Li A, Doleman S, VanderWalde A, Gansert J, Coffin RS. Talimogene Laherparepvec Improves Durable Response Rate in Patients With Advanced Melanoma. J Clin Oncol. 2015 Sep 1;33(25):2780-8. doi: 10.1200/JCO.2014.58.3377. Epub 2015 May 26. | |
| 31171039 |
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Patients were assigned at a 2:1 ratio using central random assignment to receive intralesional talimogene laherparepvec or subcutaneous granulocyte macrophage colony-stimulating factor (GM-CSF). Randomization was stratified by site of first recurrence, presence of liver metastases, disease stage, and prior nonadjuvant systemic treatment.
Eligible patients were adults with histologically confirmed, not surgically resectable, stage IIIB - IV melanoma suitable for direct or ultrasound-guided injection.
Among those randomized, the first patient enrolled 29 April 2009 and last patient enrolled 8 June 2011.
1 patient randomized 3 times is counted once under talimogene laherparepvec.
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| ID | Title | Description |
|---|---|---|
| FG000 | GM-CSF | Granulocyte macrophage colony-stimulating factor (GM-CSF) was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| GM-CSF | Biological | 125 µg/m² subcutaneous injection |
|
|
| Objective Response Rate | 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. | From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months. |
| Duration of Response | 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. | From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months. |
| Response Onset | 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. | From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months. |
| Time to Treatment Failure | 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. | From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months. |
| Response Interval | 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. | From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months. |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| University of California San Diego, Moores Cancer Center | La Jolla | California | 92093 | United States |
| UCLA Medical Center | Los Angeles | California | 90095 | United States |
| San Francisco Oncology Associates | San Francisco | California | 94115 | United States |
| Northern California Melanoma Center, St. Mary's Medical Center | San Francisco | California | 94117 | United States |
| John Wayne Cancer Institute | Santa Monica | California | 90404 | United States |
| Redwood Regional Medical Group Inc, North Bay Melanoma Program | Sebastopol | California | 95472 | United States |
| University of Colorado Cancer Center | Aurora | Colorado | 80014 | United States |
| Baptist Cancer Institute | Jacksonville | Florida | 32207 | United States |
| Lakeland Regional Cancer Center | Lakeland | Florida | 33805 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Mount Sinai Medical Center CCOP | Miami Beach | Florida | 33140 | United States |
| MD Anderson Cancer Center Orlando | Orlando | Florida | 32806 | United States |
| H. Lee Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Palm Beach Cancer Institute | West Palm Beach | Florida | 33401 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Cancer Care Center at Lutheran General Hospital | Park Ridge | Illinois | 60068 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| Investigative Clinical Research of Indiana | Indianapolis | Indiana | 46254 | United States |
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66205 | United States |
| James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | United States |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| Hubert H Humphrey Cancer Center | Robbinsdale | Minnesota | 55422 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Kansas City Cancer Center | Kansas City | Missouri | 66210 | United States |
| St. Louis University Hospital | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Methodist Estabrook Cancer Center | Omaha | Nebraska | 68114 | United States |
| Mountainside Hospital | Morristown | New Jersey | 07962 | United States |
| New Mexico Cancer Care Alliance | Albuquerque | New Mexico | 87109 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Columbia Medical University | New York | New York | 10032 | United States |
| Mount Sinai School of Medicine | New York | New York | 10032 | United States |
| University of North Carolina At Chapel Hill School of Medicine | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| Gabrail Cancer Center | Canton | Ohio | 44718 | United States |
| Barrett Cancer Center | Cincinnati | Ohio | 45267 | United States |
| Cleveland Clinic Foundation, Taussig Cancer Center | Cleveland | Ohio | 44195 | United States |
| Earle A Chiles Research Institute, Providence Cancer Center | Portland | Oregon | 97213 | United States |
| St Luke's Hospital & Health Network | Bethlehem | Pennsylvania | 18015 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02905 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Institute for Translational Oncology Research | Greenville | South Carolina | 29605 | United States |
| Vanderbilt Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| Texas Cancer Center, Abilene | Abilene | Texas | 79701 | United States |
| Mary Crowley Medical Research Center | Dallas | Texas | 75246 | United States |
| University of Texas - MD Anderson | Houston | Texas | 77030 | United States |
| Texas Oncology, Allison Cancer Center | Midland | Texas | 79701 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| Oncology and Hematology Associates of Southwest Virginia, Inc. | Salem | Virginia | 24153 | United States |
| Aurora/St. Luke's Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G2M9 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| GVI Oncology | Port Elizabeth | Eastern Cape | 6045 | South Africa |
| Dr. Fourie & Bonnet | Bloemfontein | Free State | 9301 | South Africa |
| Medical Oncology Centre of Rosebank | Johannesburg | Gauteng | 2196 | South Africa |
| Wits Donald Gordon Clinical Trial Site | Parktown | Guateng | 2193 | South Africa |
| University of Pretoria | Pretoria | Guateng | 0001 | South Africa |
| Mary Potter Oncology Centre | Pretoria | Guateng | 0075 | South Africa |
| Hopelands Cancer Centre | Pietermaritzburg | KwaZulu-Natal | 3201 | South Africa |
| Wilgers Oncology Center | Hatfield | Pretoria | 0028 | South Africa |
| GVI Onocology Clinical Trials Unit | Cape Town | Western Cape | 7500 | South Africa |
| GVI Oncology Centre | Cape Town | Western Cape | South Africa |
| University of Birmingham | Birmingham | B15 2TT | United Kingdom |
| Addenbrookes Hospital | Cambridge | CB2 0QQ | United Kingdom |
| Broomfield Hospital | Chelmsford | CM1 7ET | United Kingdom |
| St. James's University Hospital | Leeds | LS9 7TF | United Kingdom |
| Leicester Royal Infirmary | Leicester | LE1 5WW | United Kingdom |
| Royal Free Hospital | London | NW3 2QG | United Kingdom |
| St. George's University of London | London | SW17 0RE | United Kingdom |
| Royal Marsden Hospital | London | SW3 6JJ | United Kingdom |
| Clatterbridge Centre for Oncology | Metropolitan Borough of Wirral | CH63 4JY | United Kingdom |
| Freeman Hospital | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| Nottingham City Hospital | Nottingham | NG5 1PB | United Kingdom |
| Churchill Hospital | Oxford | OX3 7LJ | United Kingdom |
| Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
| Derived |
| Andtbacka RHI, Collichio F, Harrington KJ, Middleton MR, Downey G, Ӧhrling K, Kaufman HL. Final analyses of OPTiM: a randomized phase III trial of talimogene laherparepvec versus granulocyte-macrophage colony-stimulating factor in unresectable stage III-IV melanoma. J Immunother Cancer. 2019 Jun 6;7(1):145. doi: 10.1186/s40425-019-0623-z. |
| 28923101 | Derived | Kaufman HL, Andtbacka RHI, Collichio FA, Wolf M, Zhao Z, Shilkrut M, Puzanov I, Ross M. Durable response rate as an endpoint in cancer immunotherapy: insights from oncolytic virus clinical trials. J Immunother Cancer. 2017 Sep 19;5(1):72. doi: 10.1186/s40425-017-0276-8. |
| FG001 | Talimogene Laherparepvec | Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose of talimogene laherparepvec was at a concentration of 10⁶ plaque forming units (PFU)/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months. |
| Intent-to-treat Population |
|
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GM-CSF | GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months. |
| BG001 | Talimogene Laherparepvec | Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Scale used to assess how a patient's disease is progressing, how the disease affects the daily living abilities of the patient: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self care, confined to a bed or chair > 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead. | Number | participants |
| |||||||||||||||
| Tumor, Node, Metastasis (TNM) Disease Stage | Stage IIIB: Ulcerated lesion and 1 lymph node or 2-3 nodes with micrometastasis, or any-depth lesion with no ulceration, and 1 lymph node or 2-3 nodes with macrometastasis; Stage IIIC: Ulcerated lesion and 1 lymph node with macrometastasis; 2-3 nodes with macrometastasis or ≥4 metastatic lymph nodes, matted lymph nodes, or in-transit met(s)/satellite(s); Stage IV: M1a: Spread to skin, subcutaneous tissue, or lymph nodes; normal lactate dehydrogenase (LDH) level; M1b: Spread to lungs, normal LDH; M1c: Spread to all other visceral organs, normal LDH or any distant disease with elevated LDH. | Number | participants |
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| Line of Therapy | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Durable Response Rate | 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. | Intent-to-treat population (all participants randomized to receive study treatment), excluding one participant who was randomized three times. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months. |
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| Secondary | Overall Survival | 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. | Intent-to-treat population | Posted | Median | 95% Confidence Interval | months | 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. |
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| Secondary | Objective Response Rate | 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. | Intent-to-treat population | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months. |
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| Secondary | Duration of Response | 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. | Participants with an objective response (CR or PR) per EAC assessment. | Posted | Median | 95% Confidence Interval | months | From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months. |
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| Secondary | Response Onset | 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. | Participants with an objective response (CR or PR) per EAC assessment. | Posted | Median | 95% Confidence Interval | months | From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months. |
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| Secondary | Time to Treatment Failure | 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. | Intent to treat population | Posted | Median | 95% Confidence Interval | months | From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months. |
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| Secondary | Response Interval | 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. | Participants with an objective response (CR or PR) per Investigator assessment. | Posted | Median | 95% Confidence Interval | months | From randomization until the data cut-off date of 21 December 2012; median follow-up time was 20 months. |
|
From first dose of study drug until 30 days after the last dose; Median duration of treatment was 10 weeks (range 0.6 to 72 weeks) in GM-CSF group and 23 weeks (range 0.1 to 78.9 weeks) in the talimogene laherparepvec group.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GM-CSF | GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months. | 17 | 127 | 112 | 127 | ||
| EG001 | Talimogene Laherparepvec | Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months. | 75 | 292 | 282 | 292 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Delayed recovery from anaesthesia | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Radiation associated pain | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Wound decomposition | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Melanoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Plasmacytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Central nervous system lesion | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pneumocephalus | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Glomerulonephritis | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Renal papillary necrosis | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| Vitiligo | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen, Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000629782 | talimogene laherparepvec |
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| C081222 | sargramostim |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
Not provided
| Male |
|
| Black |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Other |
|
| 1 |
|
| Missing |
|
| Stage IIIC |
|
| Stage IV M1a |
|
| Stage IV M1b |
|
| Stage IV M1c |
|
| Missing |
|
| Second Line or Greater |
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ plaque forming units (PFU)/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months. |
|
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