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| ID | Type | Description | Link |
|---|---|---|---|
| V937-011 | Other Identifier | Merck Id | |
| 2019-002034-36 | EudraCT Number |
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Business Reasons
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This is a Phase 2 study to assess the efficacy, safety, and tolerability of gebasaxturev administered both intratumorally (ITu) and intravenously (IV) as combination therapy with pembrolizumab (MK-3475) versus pembrolizumab alone in anti-programmed cell death ligand 1 (anti-PD-L1)-treatment-naive participants with advanced/metastatic melanoma. The primary hypothesis of the study is that gebasaxturev administered either ITu or IV in combination with pembrolizumab results in a superior objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR), compared to pembrolizumab alone. This study will be terminated once all participants finish treatment with V937. Participants eligible to continue to receive pembrolizumab will be transferred to MK-3475-587 study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Gebasaxturev + Pembrolizumab | Experimental | Participants receive gebasaxturev at a dose of 1 X 10^9 TCID50 by IV infusion on Days 1, 3, 5, and 8 of Cycle 1 (28-day cycle) and Day 1 of Cycles 2-8 (21-day cycles) plus pembrolizumab 200 mg by IV infusion on Day 8 of Cycle 1 (28-day cycle) and Day 1 of each subsequent 21-day cycle. Gebasaxturev will be administered for up to 8 cycles (up to 6 months). Pembrolizumab will be administered for up to 35 cycles (up to 2 years). |
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| ITu Gebasaxturev + Pembrolizumab | Experimental | Participants receive gebasaxturev at a dose of 3 X 10^8 TCID50 by ITu injection on Days 1, 3, 5, and 8 of Cycle 1 (28-day cycle) and Day 1 of Cycles 2-8 (21-day cycles) plus pembrolizumab 200 mg by IV infusion on Day 8 of Cycle 1 (28-day cycle) and Day 1 of each subsequent 21-day cycle. Gebasaxturev will be administered for up to 8 cycles (up to 6 months). Pembrolizumab will be administered for up to 35 cycles (up to 2 years). |
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| Pembrolizumab | Experimental | Participants receive pembrolizumab 200 mg by IV infusion on Day 8 of Cycle 1 (28-day cycle) and Day 1 of each subsequent 21-day cycle. Pembrolizumab will be administered for up to 35 cycles (up to 2 years). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gebasaxturev IV | Biological | Administered as an IV infusion of 1 X 10^9 TCID50 |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) | ORR was defined as the percentage of participants who experienced a Complete Response (CR: disappearance of all lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions, without evidence of progression based on non-target or new lesions) as assessed by BICR per RECIST 1.1 which was modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR based on modified RECIST 1.1 is presented. | Up to ~ 35 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR | PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD. |
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Inclusion Criteria:
Has histologically or cytologically confirmed diagnosis of advanced/metastatic melanoma.
Has Stage III or Stage IV melanoma.
Must be naive to anti-PD-L1 treatment, talimogene laherparepvec (TVEC) and other oncolytic viruses.
Has 2 lesions as defined below:
Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
Demonstrates adequate organ function
Male participants refrain from donating sperm during the intervention period and for at least 120 days after the last dose of study intervention PLUS are either abstinent from heterosexual intercourse OR agree to use approved contraception during that period
Female participants are not pregnant or breastfeeding and are not a woman of childbearing potential (WOCBP) OR are a WOCBP that agrees to use contraception during the treatment and for at least 120 days after the last dose of study intervention
Has measurable disease per RECIST 1.1
Is able to provide newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART), defined as:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital ( Site 0008) | Detroit | Michigan | 48202 | United States | ||
| Rutgers Cancer Institute of New Jersey ( Site 0002) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35387488 | Derived | Deng JZ, Rustandi RR, Barbacci D, Swartz AR, Gulasarian A, Loughney JW. Reverse-Phase Ultra-Performance Chromatography Method for Oncolytic Coxsackievirus Viral Protein Separation and Empty to Full Capsid Quantification. Hum Gene Ther. 2022 Jul;33(13-14):765-775. doi: 10.1089/hum.2022.013. Epub 2022 Jun 1. |
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous (IV) Gebasaxturev + IV Pembrolizumab | Participants received gebasaxturev at a dose of 1 X 10^9 50% tissue culture infectious dose (TCID50) by IV infusion on Days 1, 3, 5, and 8 of Cycle 1 (28-day cycle) and Day 1 of Cycles 2-8 (21-day cycles) plus pembrolizumab 200 mg by IV infusion on Day 8 of Cycle 1 (28-day cycle) and Day 1 of each subsequent 21-day cycle. Gebasaxturev was administered for up to 8 cycles (up to 6 months). Pembrolizumab was administered for up to 35 cycles (up to 2 years). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2022 |
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| Gebasaxturev ITu | Biological | Administered as an ITu injection of 3 X 10^8 TCID50 |
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| Pembrolizumab | Drug | Administered as an IV infusion of 200 mg |
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| Up to ~ 35 months |
| Duration of Response (DOR) | For participants who demonstrated a confirmed complete response (CR: disappearance of all lesions) or confirmed Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions, without evidence of progression based on non-target or new lesions.) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurred first. RECIST 1.1 was adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ and was assessed by BICR for this outcome measure. | Up to ~ 35 months |
| Objective Response Rate (ORR) Per RECIST 1.1, as Assessed by the Investigator | ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 as assessed by the investigator modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR based on modified RECIST 1.1 was presented. | Up to ~ 35 months |
| Progression Free Survival (PFS) RECIST 1.1, as Assessed by the Investigator | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1 as assessed by the investigator, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. | Up to ~ 35 months |
| Duration of Response (DOR) Per RECIST 1.1, as Assessed by the Investigator | For participants who demonstrated a confirmed complete response (CR: disappearance of all lesions) or confirmed Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by the investigator, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. | Up to ~ 35 months |
| Overall Survival (OS) | OS is the time from randomization to death due to any cause. | Up to ~ 35 months |
| Percentage of Participants Who Experienced an Adverse Event (AE) | An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. | Up to ~ 37 months |
| Percentage of Participants Who Discontinued Study Drug Due to an AE | An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. | Up to ~ 27 months |
| New Brunswick |
| New Jersey |
| 08903 |
| United States |
| Providence Portland Medical Center [Portland, OR] ( Site 0005) | Portland | Oregon | 97213 | United States |
| Northwest Medical Specialties, PLLC ( Site 0006) | Tacoma | Washington | 98405 | United States |
| The Queen Elizabeth Hospital ( Site 0143) | Woodville | South Australia | 5011 | Australia |
| Alfred Health ( Site 0142) | Melbourne | Victoria | 3004 | Australia |
| Fiona Stanley Hospital ( Site 0141) | Murdoch | Western Australia | 6150 | Australia |
| FALP-UIDO ( Site 2062) | Santiago | Region M. de Santiago | 6900941 | Chile |
| Bradfordhill-Clinical Area ( Site 2061) | Santiago | Region M. de Santiago | 8420383 | Chile |
| Centre Georges Francois Leclerc ( Site 2025) | Dijon | Cote-d Or | 21079 | France |
| CHU de Grenoble Hopital Nord ( Site 2027) | La Tronche | Isere | 38700 | France |
| Universitaetsklinikum Tuebingen-Hautklinik ( Site 2001) | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Universitaetsklinikum Regensburg ( Site 2007) | Regensburg | Bavaria | 93053 | Germany |
| Universitaetsklinikum Leipzig AOeR ( Site 2005) | Leipzig | Saxony | 04103 | Germany |
| Rambam Health Care Campus-Oncology Division ( Site 0040) | Haifa | 3109601 | Israel |
| Hadassah Ein Kerem Medical Center ( Site 0042) | Jerusalem | 9112001 | Israel |
| Chaim Sheba Medical Center ( Site 0041) | Ramat Gan | 5262000 | Israel |
| Istituto Europeo di Oncologia ( Site 2040) | Milan | 20141 | Italy |
| Policlinico Le Scotte - A.O. Senese ( Site 2039) | Siena | 53100 | Italy |
| Oslo Universitetssykehus Radiumhospitalet ( Site 0060) | Oslo | 0424 | Norway |
| WITS Clinical Research CMJAH Clinical Trial Site ( Site 0101) | Johannesburg | Gauteng | 2193 | South Africa |
| Clinical Research Unit - University of Pretoria ( Site 0102) | Pretoria | Gauteng | 0002 | South Africa |
| Wilgers Oncology Centre ( Site 0103) | Pretoria | Gauteng | 0081 | South Africa |
| Little Company of Mary Hospital ( Site 0100) | Pretoria | Gauteng | 0181 | South Africa |
| Cape Town Oncology Trials Pty Ltd ( Site 0104) | Cape Town | Western Cape | 7570 | South Africa |
| Seoul National University Hospital ( Site 1992) | Seoul | 03080 | South Korea |
| Severance Hospital Yonsei University Health System ( Site 1993) | Seoul | 03722 | South Korea |
| Onkologikoa - Instituto Oncologico de San Sebastian ( Site 0088) | Donostia / San Sebastian | Gipuzkoa | 20014 | Spain |
| Clinica Universitaria de Navarra. ( Site 0082) | Pamplona | Navarre | 31008 | Spain |
| Hospital Clinico Universitario de Valencia ( Site 0090) | Valencia | Valenciana, Comunitat | 46010 | Spain |
| FG001 | Intratumoral (ITu) Gebasaxturev + IV Pembrolizumab | Participants received gebasaxturev at a dose of 3 X 10^8 TCID50 by ITu injection on Days 1, 3, 5, and 8 of Cycle 1 (28-day cycle) and Day 1 of Cycles 2-8 (21-day cycles) plus pembrolizumab 200 mg by IV infusion on Day 8 of Cycle 1 (28-day cycle) and Day 1 of each subsequent 21-day cycle. Gebasaxturev was administered for up to 8 cycles (up to 6 months). Pembrolizumab was administered for up to 35 cycles (up to 2 years). |
| FG002 | Pembrolizumab IV | Participants received pembrolizumab 200 mg by IV infusion on Day 8 of Cycle 1 (28-day cycle) and Day 1 of each subsequent 21-day cycle. Pembrolizumab was administered for up to 35 cycles (up to 2 years). |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous (IV) Gebasaxturev + IV Pembrolizumab | Participants received gebasaxturev at a dose of 1 X 10^9 50% tissue culture infectious dose (TCID50) by IV infusion on Days 1, 3, 5, and 8 of Cycle 1 (28-day cycle) and Day 1 of Cycles 2-8 (21-day cycles) plus pembrolizumab 200 mg by IV infusion on Day 8 of Cycle 1 (28-day cycle) and Day 1 of each subsequent 21-day cycle. Gebasaxturev was administered for up to 8 cycles (up to 6 months). Pembrolizumab was administered for up to 35 cycles (up to 2 years). |
| BG001 | Intratumoral (ITu) Gebasaxturev + IV Pembrolizumab | Participants received gebasaxturev at a dose of 3 X 10^8 TCID50 by ITu injection on Days 1, 3, 5, and 8 of Cycle 1 (28-day cycle) and Day 1 of Cycles 2-8 (21-day cycles) plus pembrolizumab 200 mg by IV infusion on Day 8 of Cycle 1 (28-day cycle) and Day 1 of each subsequent 21-day cycle. Gebasaxturev was administered for up to 8 cycles (up to 6 months). Pembrolizumab was administered for up to 35 cycles (up to 2 years). |
| BG002 | Pembrolizumab IV | Participants received pembrolizumab 200 mg by IV infusion on Day 8 of Cycle 1 (28-day cycle) and Day 1 of each subsequent 21-day cycle. Pembrolizumab was administered for up to 35 cycles (up to 2 years). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Cancer M Staging at Baseline | Randomization was stratified based on 4 metastatic melanoma subsets: M1a (nonvisceral (distant cutaneous, subcutaneous, nodal); M1b (lung); M1c (noncentral nervous system (CNS) visceral); and M1d (involves the CNS), as defined by the AJCC (American Joint Committee on Cancer) Cancer Staging Manual, Eighth Edition. M1c and M1d have different prognoses compared to M1a and M1b, warranting stratification. | Count of Participants | Participants |
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| 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 | Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) | ORR was defined as the percentage of participants who experienced a Complete Response (CR: disappearance of all lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions, without evidence of progression based on non-target or new lesions) as assessed by BICR per RECIST 1.1 which was modified for this study to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR based on modified RECIST 1.1 is presented. | All allocated participants included in the treatment group to which they were allocated. | Posted | Number | 90% Confidence Interval | Percentage of Participants | Up to ~ 35 months |
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| Secondary | Progression Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR | PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD. | All allocated participants included in the treatment group to which they were allocated. | Posted | Median | 95% Confidence Interval | Months | Up to ~ 35 months |
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| Secondary | Duration of Response (DOR) | For participants who demonstrated a confirmed complete response (CR: disappearance of all lesions) or confirmed Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions, without evidence of progression based on non-target or new lesions.) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurred first. RECIST 1.1 was adjusted for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ and was assessed by BICR for this outcome measure. | All allocated participants included in the treatment group to which they were allocated. | Posted | Median | Full Range | Months | Up to ~ 35 months |
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| Secondary | Objective Response Rate (ORR) Per RECIST 1.1, as Assessed by the Investigator | ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 as assessed by the investigator modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR based on modified RECIST 1.1 was presented. | All allocated participants included in the treatment group to which they were allocated. | Posted | Number | 90% Confidence Interval | Percentage of Participants | Up to ~ 35 months |
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| Secondary | Progression Free Survival (PFS) RECIST 1.1, as Assessed by the Investigator | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1 as assessed by the investigator, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. | All allocated participants included in the treatment group to which they were allocated. | Posted | Median | 95% Confidence Interval | Months | Up to ~ 35 months |
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| Secondary | Duration of Response (DOR) Per RECIST 1.1, as Assessed by the Investigator | For participants who demonstrated a confirmed complete response (CR: disappearance of all lesions) or confirmed Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by the investigator, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. | All allocated participants included in the treatment group to which they were allocated. | Posted | Median | Full Range | Months | Up to ~ 35 months |
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| Secondary | Overall Survival (OS) | OS is the time from randomization to death due to any cause. | All allocated participants included in the treatment group to which they were allocated. | Posted | Median | 95% Confidence Interval | Months | Up to ~ 35 months |
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| Secondary | Percentage of Participants Who Experienced an Adverse Event (AE) | An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. | All randomized participants who received at least one dose of study medication. Participants were analyzed in the treatment arm corresponding to the study treatment they actually received. | Posted | Number | Percentage of Participants | Up to ~ 37 months |
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| Secondary | Percentage of Participants Who Discontinued Study Drug Due to an AE | An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. | All randomized participants who received at least one dose of study medication. Participants were analyzed in the treatment arm corresponding to the study treatment they actually received. | Posted | Number | Percentage of Participants | Up to ~ 27 months |
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Up to ~ 37 months
All-cause mortality (ACM) was analyzed in all randomized participants. Safety analyses were conducted in all randomized participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA 26.0 preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intravenous (IV) Gebasaxturev + IV Pembrolizumab | Participants received gebasaxturev at a dose of 1 X 10^9 50% tissue culture infectious dose (TCID50) by IV infusion on Days 1, 3, 5, and 8 of Cycle 1 (28-day cycle) and Day 1 of Cycles 2-8 (21-day cycles) plus pembrolizumab 200 mg by IV infusion on Day 8 of Cycle 1 (28-day cycle) and Day 1 of each subsequent 21-day cycle. Gebasaxturev was administered for up to 8 cycles (up to 6 months). Pembrolizumab was administered for up to 35 cycles (up to 2 years). | 14 | 28 | 8 | 28 | 27 | 28 |
| EG001 | Intratumoral (ITu) Gebasaxturev + IV Pembrolizumab | Participants received gebasaxturev at a dose of 3 X 10^8 TCID50 by ITu injection on Days 1, 3, 5, and 8 of Cycle 1 (28-day cycle) and Day 1 of Cycles 2-8 (21-day cycles) plus pembrolizumab 200 mg by IV infusion on Day 8 of Cycle 1 (28-day cycle) and Day 1 of each subsequent 21-day cycle. Gebasaxturev was administered for up to 8 cycles (up to 6 months). Pembrolizumab was administered for up to 35 cycles (up to 2 years). | 12 | 28 | 5 | 28 | 27 | 28 |
| EG002 | Pembrolizumab IV | Participants received pembrolizumab 200 mg by IV infusion on Day 8 of Cycle 1 (28-day cycle) and Day 1 of each subsequent 21-day cycle. Pembrolizumab was administered for up to 35 cycles (up to 2 years). | 9 | 29 | 4 | 26 | 22 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
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| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
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| Adrenal insufficiency | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Axillary pain | General disorders | MedDRA 26.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 26.0 | Systematic Assessment |
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| Overlap syndrome | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Septic rash | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
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| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
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| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
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| Prostatic adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
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| Eosinophilia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
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| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 26.0 | Systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA 26.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Xerosis | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 26.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Vitiligo | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 26.0 | Systematic Assessment |
|
This study was terminated due to the sponsor's development decision.
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Jul 11, 2024 |
| Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008545 | Melanoma |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| 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 |
|---|---|
| C582435 | pembrolizumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| M1b |
|
| M1c |
|
| M1d |
|
| Missing |
|
| Stratified Miettinen & Nurminen method |
To ensure adequate number of participants, strata were combined according to sSAP when one treatment had 0 participants in a particular stratum. |
| 0.3548 |
| Mean Difference (Net) |
| 4.8 |
| 2-Sided |
| 90 |
| -16.2 |
| 25.5 |
| Superiority |
| Difference in % | 7.1 | 2-Sided | 90 | -14.6 | 28.2 | Other | Difference in percentage based on Miettinen & Nurminen method. |
| OG002 | Pembrolizumab IV | Participants received pembrolizumab 200 mg by IV infusion on Day 8 of Cycle 1 (28-day cycle) and Day 1 of each subsequent 21-day cycle. Pembrolizumab was administered for up to 35 cycles (up to 2 years). |
|
|
|
| OG002 | Pembrolizumab IV | Participants received pembrolizumab 200 mg by IV infusion on Day 8 of Cycle 1 (28-day cycle) and Day 1 of each subsequent 21-day cycle. Pembrolizumab was administered for up to 35 cycles (up to 2 years). |
|
|
| OG002 | Pembrolizumab IV | Participants received pembrolizumab 200 mg by IV infusion on Day 8 of Cycle 1 (28-day cycle) and Day 1 of each subsequent 21-day cycle. Pembrolizumab was administered for up to 35 cycles (up to 2 years). |
|
|
|
| OG002 | Pembrolizumab IV | Participants received pembrolizumab 200 mg by IV infusion on Day 8 of Cycle 1 (28-day cycle) and Day 1 of each subsequent 21-day cycle. Pembrolizumab was administered for up to 35 cycles (up to 2 years). |
|
|
|
| OG002 | Pembrolizumab IV | Participants received pembrolizumab 200 mg by IV infusion on Day 8 of Cycle 1 (28-day cycle) and Day 1 of each subsequent 21-day cycle. Pembrolizumab was administered for up to 35 cycles (up to 2 years). |
|
|
Participants received pembrolizumab 200 mg by IV infusion on Day 8 of Cycle 1 (28-day cycle) and Day 1 of each subsequent 21-day cycle. Pembrolizumab was administered for up to 35 cycles (up to 2 years). |
|
|
|
| OG002 | Pembrolizumab IV | Participants received pembrolizumab 200 mg by IV infusion on Day 8 of Cycle 1 (28-day cycle) and Day 1 of each subsequent 21-day cycle. Pembrolizumab was administered for up to 35 cycles (up to 2 years). |
|
|
| OG002 | Pembrolizumab IV | Participants received pembrolizumab 200 mg by IV infusion on Day 8 of Cycle 1 (28-day cycle) and Day 1 of each subsequent 21-day cycle. Pembrolizumab was administered for up to 35 cycles (up to 2 years). |
|
|