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| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
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This is a Phase 1b/2a, open-label, multi-center, dose-escalation and safety/efficacy evaluation trial of Pexa-Vec plus Cemiplimab in patients with metastatic or unresectable renal cell carcinoma (RCC). The trial consists of a dose-escalation stage, where the maximum feasible dose of Pexa-Vec in combination with Cemiplimab will be determined, followed by an expansion stage. During the expansion patients will receive Cemiplimab alone or in combination with Pexa-Vec, which will be administered either through intravenous (IV) or intratumoral (IT) injection.
For Pexa-Vec IV infusions (Part 1 / Part 2: Arm C and Arm D): Day -7, 1, 8, and 15), patients allocated to Part 1 or Part 2: Arm C or Arm D will receive an IV infusion of Pexa-Vec in approximately 250 mL buffered saline.
For Pexa-Vec IT Injections (Part 2 Arm A + Arm B), patients in Part 2, Arm A (and those in Arm B who progress on Cemiplimab monotherapy) will receive an IT injection of Pexa-Vec in a volume of buffered saline dependent on size of tumor(s).
For administration of Cemiplimab, Cemiplimab will be administered at a dose of 350 mg IV infusion over 30 minutes (±10 minutes) every 3 weeks per manufactures guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1, Dose escalation 3 x 10^8 pfu | Experimental | Pexa-Vec will be administered via IV infusion at a dose of 3 x 10^8 pfu once per week for 4 treatments. Based on the occurrence of dose-limiting toxicities, patients may subsequently be enrolled to receive Pexa-Vec on the same schedule at a dose of 3 x 10^8 pfu. Cemiplimab will be administered via IV infusion every 3 weeks. |
|
| Part 1, Dose escalation 1 x 10^9 pfu | Experimental | Pexa-Vec will be administered via IV infusion at a dose of 1 x 10^9 pfu once per week for 4 treatments. Based on the occurrence of dose-limiting toxicities, patients may subsequently be enrolled to receive Pexa-Vec on the same schedule at a dose of 1 x 10^9 pfu. |
|
| Part 2-Arm A, Pexa-Vec (IT) and Cemiplimab | Experimental | Pexa-Vec will be administered via IT (intratumoral) injection every 2 weeks for 3 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
|
| Part 2-Arm B, Cemiplimab | Experimental | Cemiplimab will be administered via IV infusion every 3 weeks. At disease progression, Pexa-Vec will be administered via IT (intratumoral) injection every 2 weeks for 3 treatments. Cemiplimab will continue every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pexastimogene Devacirepvec (Pexa-Vec) | Biological | Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Participants With Adverse Events From Pexa-Vec Administered by IV Infusions or IT Injections in Combination With IV Cemiplimab | Safety will be determined by assessing the incidence, severity, and frequency of all treatment-emergent adverse events (TEAEs), Grade 3 or greater AEs, serious adverse events (SAEs), laboratory toxicity, AEs requiring discontinuation of study agent(s), and deaths. The severity of all adverse events and laboratory abnormalities is assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. Safety is monitored from the first dose throughout the treatment period (up to a maximum of 1 year) and up to 28 days after the last dose of study treatment. | Through study completion without survival follow-up period, an average of 1 year |
| Overall Response Rate | Overall response rate (ORR) is defined as the proportion of patients whose best overall responses either complete response (CR) or partial response (PR). The best overall response is the best response recorded from the randomization until disease progression. Proportions of patients with a best overall response of CR, disappearance of all target tumors; or PR, at least 30% decrease in the sum of longest diameter of target tumors will be presented by treatment arm along with exact 95% CIs. Analyses will be performed based on central assessments using RECIST v1.1. | Every 9 weeks until documented progression or discontinuation beyond documented progression. After 1 year, every 12 weeks from EOT visit, up to 36 months. |
| Number of Participants With Dose Limiting Toxicities of Pexa-Vec Administered by IV Infusions in Combination With Cemiplimab (Part 1 Only) | Dose-limiting toxicity (DLT) was assessed to determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of Pexa-Vec. Patients were observed for DLTs during the IV treatment phase through Day 29. DLTs are evaluated based on the severity and frequency of adverse events and laboratory abnormalities using NCI CTCAE Version 5.0. | The 29-day cycle of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Defined as the date of the first study treatment to the date of first documented radiographic tumor progression or death due to any cause, whichever occurs first (RECIST v1.1). Progression free survival will be presented descriptively using Kaplan-Meier curves. Summary statistics from the Kaplan-Meier distributions will be determined, including median PFS and 25% and 75% quartiles with corresponding 95% CIs. The proportions of patients. |
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Inclusion Criteria:
Histologically or cytologically confirmed metastatic or unresectable clear cell renal cell carcinoma (ccRCC)
Part 2 Arm D ONLY: Patients must be refractory to anti PD-1 or anti-PD-L1 (either as monotherapy or in-combination with other approved checkpoint inhibitors or targeted therapies according to their approved label) and patients must meet all of the following criteria:
Naive to systemic therapy for RCC or have progressed after, or were intolerant of, prior systemic therapy.
Measurable disease based on RECIST v1.1 criteria. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
Karnofsky performance status of 70-100
Age ≥20 years old (or appropriate age of consent for the region)
Adequate hematological, hepatic, and renal function
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SillaJen Inc. | SillaJen, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 2644 University of California, Irvine | Irvine | California | 92868 | United States | ||
| Site 2641 University of Miami |
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| Label | URL |
|---|---|
| Related Info | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Abstract | View IPD |
A total of 141 patients were screened for eligibility prior to group assignment, which included 8 patients for Part 1 and 133 patients for Part 2. Of these, 46 patients failed the screening process (2 patients in Part 1 and 44 patients in Part 2). Consequently, a total of 95 eligible patients were enrolled and assigned to the study groups (6 patients in Part 1 and 89 patients in Part 2).
Patients with histologically or cytologically confirmed metastatic or unresectable clear cell Renal Cell Carcinoma (RCC) were recruited for this study. The recruitment took place at 17 study centers across the United States, South Korea, and Australia. The first patient was enrolled on June 19, 2018, and the last patient completed the study on February 16, 2023. It was noted that there were some recruitment limitations due to intratumoral injection constraints.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1 3 x 10^8 Pfu | Part 1 will determine the MTD/MFD of Pexa-Vec, when given in combination with Cemiplimab at a dose of 350 mg. Dosage cohorts per IV infusion: Dose Level 1: 3 x 10^8 pfu Dose Level 2: 1 x 10^9 pfu Pexa-Vec IV Infusion will be administered weekly x 4 treatments starting on study Day -7 (Days 7, 1, 8, and 15 [Window: -1/+7 days]). Cemiplimab IV infusion will be administered every 3 weeks, at a dose of 350 mg, starting on study Day 1 (Day 1, 22, 43…) [Window: ±3 days] |
| 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 | Yes | No | No | Study Protocol: Protocol JX594-REN026 Ex-US Amendment 9 | Nov 24, 2020 |
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| Part 2-Arm C, Pexa-Vec (IV) and Cemiplimab | Experimental | Pexa-Vec will be administered via IV infusion once per week for 4 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
|
| Part 2-Arm D, Pexa-Vec (IV) and Cemiplimab | Experimental | Pexa-Vec will be administered via IV infusion once per week for 4 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
|
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| Cemiplimab | Biological | Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
|
| Every 9 weeks until documented progression or discontinuation beyond documented progression. After 1 year, every 12 weeks from EOT visit, up to 36 months |
| Disease Control Rate | Defined as the proportion of patients whose best overall response is either complete response (CR), partial response (PR), or stable disease (SD). (RECIST v1.1) | Every 9 weeks until documented progression or discontinuation beyond documented progression. After 1 year, every 12 weeks from EOT visit, up to 36 months |
| Overall Survival | Overall survival is defined as the time from first study treatment until death from any cause. For patients not known to have died at the time of the analysis, overall survival will be censored on the date they were last known to be alive. If a patient withdraws early, overall survival will not be censored at the date of withdrawal unless this is the date they were last known to be alive. Date of death will be obtained from the death certificate (preferable) or from a written statement from the primary care or attending physician, or from death registry data. Additionally, for censored date, the latest date of (in the following order): End of Treatment visit(EOT) / Last Radiologic Timepoint(LastRTP) / End of Study(EOS) / Last Drug Date(D.LastDrug) / before cutoff date(2023-02-16) is the censored date. | Every 9 weeks until documented progression or discontinuation beyond documented progression. After 1 year, every 12 weeks from EOT visit, up to 36 months |
| Miami |
| Florida |
| 33136 |
| United States |
| Site 2643 Washington University | St Louis | Missouri | 63141 | United States |
| Site 2642 Billings Clinic | Billings | Montana | 59101 | United States |
| Site 2646 The Ohio State University | Columbus | Ohio | 43201 | United States |
| Site 2632 Flinders Medical Centre | Bedford Park | SA5042 | Australia |
| Site 2631 | Camperdown | Australia |
| Site 2612 Kyungpook National University Chilgok Hospital | Daegu | 41404 | South Korea |
| Site 2616 Chungnam National University Hospital | Daejeon | 35015 | South Korea |
| Site 2618 Chonnam National University Hwasun Hospital | Gwangju | 58128 | South Korea |
| Site 2622 Gachon University Gil Medical Center | Incheon | South Korea |
| Site 2614 Gyeongsang National University Hospital | Jinju | 52727 | South Korea |
| Site 2613 Dong-A University Hospital | Pusan | 49201 | South Korea |
| Site 2619 Pusan National University Hospital | Pusan | 49241 | South Korea |
| Site 2617 CHA University, CHA Bundang Medical Center | Seongnam | 35015 | South Korea |
| Site 2620 Seoul National University Bundang Hospital | Seongnam-si | 13620 | South Korea |
| Site 2615 Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Site 2610 Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Site 2623 Ajou University Hospital | Suwon | 16499 | South Korea |
| Site 2625 Wonju Severance Christian Hospital | Wŏnju | 50612 | South Korea |
| Site 2624 Pusan National University Yangsan Hospital | Yangsan | 50612 | South Korea |
| FG001 | Part 1 1 x 10^9 Pfu | Part 1 will determine the MTD/MFD of Pexa-Vec, when given in combination with Cemiplimab at a dose of 350 mg. Dosage cohorts per IV infusion: Dose Level 1: 3 x 10^8 pfu Dose Level 2: 1 x 10^9 pfu Pexa-Vec IV Infusion will be administered weekly x 4 treatments starting on study Day -7 (Days 7, 1, 8, and 15 [Window: -1/+7 days]). Cemiplimab IV infusion will be administered every 3 weeks, at a dose of 350 mg, starting on study Day 1 (Day 1, 22, 43…) [Window: ±3 days] |
| FG002 | Part 2-Arm A, Pexa-Vec (IT) and Cemiplimab | Pexa-Vec will be administered via IT (intratumoral) injection every 2 weeks for 3 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
| FG003 | Part 2-Arm B, Cemiplimab | Cemiplimab will be administered via IV infusion every 3 weeks. At disease progression, Pexa-Vec will be administered via IT (intratumoral) injection every 2 weeks for 3 treatments. Cemiplimab will continue every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
| FG004 | Part 2-Arm C, Pexa-Vec (IV) and Cemiplimab | Pexa-Vec will be administered via IV infusion once per week for 4 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
| FG005 | Part 2-Arm D, Pexa-Vec (IV) and Cemiplimab | Pexa-Vec will be administered via IV infusion once per week for 4 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1 : 3 x 10^8 Pfu | Part 1 will determine the MTD/MFD of Pexa-Vec, when given in combination with Cemiplimab at a dose of 350 mg. Dosage cohorts per IV infusion: Dose Level 1: 3 x 10^8 pfu Dose Level 2: 1 x 10^9 pfu Pexa-Vec IV Infusion will be administered weekly x 4 treatments starting on study Day -7 (Days 7, 1, 8, and 15 [Window: -1/+7 days]). Cemiplimab IV infusion will be administered every 3 weeks, at a dose of 350 mg, starting on study Day 1 (Day 1, 22, 43…) [Window: ±3 days] |
| BG001 | Part 1 : 1 x 10^9 Pfu | Part 1 will determine the MTD/MFD of Pexa-Vec, when given in combination with Cemiplimab at a dose of 350 mg. Dosage cohorts per IV infusion: Dose Level 1: 3 x 10^8 pfu Dose Level 2: 1 x 10^9 pfu Pexa-Vec IV Infusion will be administered weekly x 4 treatments starting on study Day -7 (Days 7, 1, 8, and 15 [Window: -1/+7 days]). Cemiplimab IV infusion will be administered every 3 weeks, at a dose of 350 mg, starting on study Day 1 (Day 1, 22, 43…) [Window: ±3 days] |
| BG002 | Part 2-Arm A, Pexa-Vec (IT) and Cemiplimab | Pexa-Vec will be administered via IT (intratumoral) injection every 2 weeks for 3 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
| BG003 | Part 2-Arm B, Cemiplimab | Cemiplimab will be administered via IV infusion every 3 weeks. At disease progression, Pexa-Vec will be administered via IT (intratumoral) injection every 2 weeks for 3 treatments. Cemiplimab will continue every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
| BG004 | Part 2-Arm C, Pexa-Vec (IV) and Cemiplimab | Pexa-Vec will be administered via IV infusion once per week for 4 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
| BG005 | Part 2-Arm D, Pexa-Vec (IV) and Cemiplimab | Pexa-Vec will be administered via IV infusion once per week for 4 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
| BG006 | 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Region of Enrollment refers to the geographical locations (countries) where participants were enrolled and received study treatment. This study was conducted at 17 clinical sites across the United States, the Republic of Korea, and Australia | Number | Participants |
| ||||||||||
| Baseline Tumor Size | Baseline tumor size is defined as the sum of the diameters of all target lesions identified at screening. Measurements were performed using Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) and evaluated by central radiologic review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. | The number of participants analyzed for this baseline measure is lower than the overall number of enrolled participants in each arm because valid baseline tumor size measurements per Central Radiologic Review (Central RECIST 1.1) were not available or evaluable for all enrolled participants. | Mean | Standard Deviation | Centimeters (cm) |
|
| 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 | Number and Percentage of Participants With Adverse Events From Pexa-Vec Administered by IV Infusions or IT Injections in Combination With IV Cemiplimab | Safety will be determined by assessing the incidence, severity, and frequency of all treatment-emergent adverse events (TEAEs), Grade 3 or greater AEs, serious adverse events (SAEs), laboratory toxicity, AEs requiring discontinuation of study agent(s), and deaths. The severity of all adverse events and laboratory abnormalities is assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. Safety is monitored from the first dose throughout the treatment period (up to a maximum of 1 year) and up to 28 days after the last dose of study treatment. | The safety group had 88 subjects and the ITT group had 89 subjects, which is the correct value as the table safety group had 88 subjects (Arm B 16 subjects). | Posted | Count of Participants | Participants | Through study completion without survival follow-up period, an average of 1 year |
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| Primary | Overall Response Rate | Overall response rate (ORR) is defined as the proportion of patients whose best overall responses either complete response (CR) or partial response (PR). The best overall response is the best response recorded from the randomization until disease progression. Proportions of patients with a best overall response of CR, disappearance of all target tumors; or PR, at least 30% decrease in the sum of longest diameter of target tumors will be presented by treatment arm along with exact 95% CIs. Analyses will be performed based on central assessments using RECIST v1.1. | Posted | Number | 95% Confidence Interval | percentage of participants | Every 9 weeks until documented progression or discontinuation beyond documented progression. After 1 year, every 12 weeks from EOT visit, up to 36 months. |
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| Primary | Number of Participants With Dose Limiting Toxicities of Pexa-Vec Administered by IV Infusions in Combination With Cemiplimab (Part 1 Only) | Dose-limiting toxicity (DLT) was assessed to determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of Pexa-Vec. Patients were observed for DLTs during the IV treatment phase through Day 29. DLTs are evaluated based on the severity and frequency of adverse events and laboratory abnormalities using NCI CTCAE Version 5.0. | As per the study protocol, Dose-Limiting Toxicity (DLT) was assessed only in Part 1 (dose-escalation phase) to determine the maximum tolerated dose. Therefore, Part 2 arms are not included in this outcome measure. Participants in Part 1 were analyzed separately by dose level (3 x 10^8 pfu and 1 x 10^9 pfu). The reported value of 0 represents the actual clinical result that no participant experienced a DLT during the observation period. | Posted | Number | participants | The 29-day cycle of therapy |
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| Secondary | Progression Free Survival | Defined as the date of the first study treatment to the date of first documented radiographic tumor progression or death due to any cause, whichever occurs first (RECIST v1.1). Progression free survival will be presented descriptively using Kaplan-Meier curves. Summary statistics from the Kaplan-Meier distributions will be determined, including median PFS and 25% and 75% quartiles with corresponding 95% CIs. The proportions of patients. | Posted | Median | 80% Confidence Interval | Months | Every 9 weeks until documented progression or discontinuation beyond documented progression. After 1 year, every 12 weeks from EOT visit, up to 36 months |
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| Secondary | Disease Control Rate | Defined as the proportion of patients whose best overall response is either complete response (CR), partial response (PR), or stable disease (SD). (RECIST v1.1) | Posted | Number | 95% Confidence Interval | percentage of participants | Every 9 weeks until documented progression or discontinuation beyond documented progression. After 1 year, every 12 weeks from EOT visit, up to 36 months |
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| Secondary | Overall Survival | Overall survival is defined as the time from first study treatment until death from any cause. For patients not known to have died at the time of the analysis, overall survival will be censored on the date they were last known to be alive. If a patient withdraws early, overall survival will not be censored at the date of withdrawal unless this is the date they were last known to be alive. Date of death will be obtained from the death certificate (preferable) or from a written statement from the primary care or attending physician, or from death registry data. Additionally, for censored date, the latest date of (in the following order): End of Treatment visit(EOT) / Last Radiologic Timepoint(LastRTP) / End of Study(EOS) / Last Drug Date(D.LastDrug) / before cutoff date(2023-02-16) is the censored date. | Posted | Median | 80% Confidence Interval | month | Every 9 weeks until documented progression or discontinuation beyond documented progression. After 1 year, every 12 weeks from EOT visit, up to 36 months |
|
All-Cause Mortality was assessed throughstudy completion, up to 36 months; all adverse events were collected through studycompletion with survival follow-up period, an average of 1 year"
AE which is a medical occurrence or deterioration of a pre-existing medical condition occurring after initiation of study treatment and even if the event is not considered to be related to the study treatment(s) will be collected. Part 2-Arm B, Cemiplimab" Arm/Group differs between the All-Cause Mortality and Serious/Other Adverse Events because all-Cause Mortality assessed in entire population and Serious/Other Adverse Events assessed in treated population.
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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 | Part 1 3 x 10^8 Pfu | Part 1 will determine the MTD/MFD of Pexa-Vec, when given in combination with Cemiplimab at a dose of 350 mg. Dosage cohorts per IV infusion: Dose Level 1: 3 x 10^8 pfu Dose Level 2: 1 x 10^9 pfu Pexa-Vec IV Infusion will be administered weekly x 4 treatments starting on study Day -7 (Days 7, 1, 8, and 15 [Window: -1/+7 days]). Cemiplimab IV infusion will be administered every 3 weeks, at a dose of 350 mg, starting on study Day 1 (Day 1, 22, 43…) [Window: ±3 days] | 1 | 3 | 2 | 3 | 3 | 3 |
| EG001 | Part 1 1 x 10^9 Pfu | Part 1 will determine the MTD/MFD of Pexa-Vec, when given in combination with Cemiplimab at a dose of 350 mg. Dosage cohorts per IV infusion: Dose Level 1: 3 x 10^8 pfu Dose Level 2: 1 x 10^9 pfu Pexa-Vec IV Infusion will be administered weekly x 4 treatments starting on study Day -7 (Days 7, 1, 8, and 15 [Window: -1/+7 days]). Cemiplimab IV infusion will be administered every 3 weeks, at a dose of 350 mg, starting on study Day 1 (Day 1, 22, 43…) [Window: ±3 days] | 0 | 3 | 1 | 3 | 3 | 3 |
| EG002 | Part 2-Arm A, Pexa-Vec (IT) and Cemiplimab | Pexa-Vec will be administered via IT (intratumoral) injection every 2 weeks for 3 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) | 3 | 15 | 6 | 15 | 15 | 15 |
| EG003 | Part 2-Arm B, Cemiplimab | Cemiplimab will be administered via IV infusion every 3 weeks. At disease progression, Pexa-Vec will be administered via IT (intratumoral) injection every 2 weeks for 3 treatments. Cemiplimab will continue every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) | 2 | 16 | 6 | 15 | 15 | 15 |
| EG004 | Part 2-Arm C, Pexa-Vec (IV) and Cemiplimab | Pexa-Vec will be administered via IV infusion once per week for 4 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) | 5 | 30 | 11 | 30 | 30 | 30 |
| EG005 | Part 2-Arm D, Pexa-Vec (IV) and Cemiplimab | Pexa-Vec will be administered via IV infusion once per week for 4 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) | 5 | 28 | 11 | 28 | 28 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Histiocytosis haematophagic | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Septic shock | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Asthenia | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Systematic Assessment |
| |
| Brain cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Systematic Assessment |
| |
| Brain neoplasm benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Renal vein thrombosis | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | CTCAE (5.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Fibrin D dimer increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Device occlusion | Product Issues | CTCAE (5.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Nail infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
| |
| Amylase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Disclosure Representative | SillaJen Biotherapeutics, Inc. | (415) 281-8886 | medical_affairs@kr.sillajen.com |
| Jan 23, 2024 |
| Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Protocol JX594-REN026 Amendment 9 | Nov 24, 2020 | Jan 23, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 27, 2023 | Jan 23, 2024 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000627974 | cemiplimab |
Not provided
Not provided
Not provided
|
|
|
|
|
|
| South Korea |
|
|
| Australia |
|
|
|
| Serious adverse events |
|
| AEs requiring discontinuation of study agent(s) |
|
| Deaths according to NCI-CTC V5 |
|
| OG002 | Part 2-Arm A, Pexa-Vec (IT) and Cemiplimab | Pexa-Vec will be administered via IT (intratumoral) injection every 2 weeks for 3 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
| OG003 | Part 2-Arm B, Cemiplimab | Cemiplimab will be administered via IV infusion every 3 weeks. At disease progression, Pexa-Vec will be administered via IT (intratumoral) injection every 2 weeks for 3 treatments. Cemiplimab will continue every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
| OG004 | Part 2-Arm C, Pexa-Vec (IV) and Cemiplimab | Pexa-Vec will be administered via IV infusion once per week for 4 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
| OG005 | Part 2-Arm D, Pexa-Vec (IV) and Cemiplimab | Pexa-Vec will be administered via IV infusion once per week for 4 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
|
|
Part 1 will determine the MTD/MFD of Pexa-Vec, when given in combination with Cemiplimab at a dose of 350 mg. Dosage cohorts per IV infusion: Dose Level 1: 3 x 10^8 pfu Dose Level 2: 1 x 10^9 pfu Pexa-Vec IV Infusion will be administered weekly x 4 treatments starting on study Day -7 (Days 7, 1, 8, and 15 [Window: -1/+7 days]). Cemiplimab IV infusion will be administered every 3 weeks, at a dose of 350 mg, starting on study Day 1 (Day 1, 22, 43…) [Window: ±3 days] |
|
|
| OG002 | Part 2-Arm A, Pexa-Vec (IT) and Cemiplimab | Pexa-Vec will be administered via IT (intratumoral) injection every 2 weeks for 3 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
| OG003 | Part 2-Arm B, Cemiplimab | Cemiplimab will be administered via IV infusion every 3 weeks. At disease progression, Pexa-Vec will be administered via IT (intratumoral) injection every 2 weeks for 3 treatments. Cemiplimab will continue every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
| OG004 | Part 2-Arm C, Pexa-Vec (IV) and Cemiplimab | Pexa-Vec will be administered via IV infusion once per week for 4 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
| OG005 | Part 2-Arm D, Pexa-Vec (IV) and Cemiplimab | Pexa-Vec will be administered via IV infusion once per week for 4 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
|
|
| OG002 |
| Part 2-Arm A, Pexa-Vec (IT) and Cemiplimab |
Pexa-Vec will be administered via IT (intratumoral) injection every 2 weeks for 3 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
| OG003 | Part 2-Arm B, Cemiplimab | Cemiplimab will be administered via IV infusion every 3 weeks. At disease progression, Pexa-Vec will be administered via IT (intratumoral) injection every 2 weeks for 3 treatments. Cemiplimab will continue every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
| OG004 | Part 2-Arm C, Pexa-Vec (IV) and Cemiplimab | Pexa-Vec will be administered via IV infusion once per week for 4 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
| OG005 | Part 2-Arm D, Pexa-Vec (IV) and Cemiplimab | Pexa-Vec will be administered via IV infusion once per week for 4 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
|
|
Part 1 will determine the MTD/MFD of Pexa-Vec, when given in combination with Cemiplimab at a dose of 350 mg. Dosage cohorts per IV infusion: Dose Level 1: 3 x 10^8 pfu Dose Level 2: 1 x 10^9 pfu Pexa-Vec IV Infusion will be administered weekly x 4 treatments starting on study Day -7 (Days 7, 1, 8, and 15 [Window: -1/+7 days]). Cemiplimab IV infusion will be administered every 3 weeks, at a dose of 350 mg, starting on study Day 1 (Day 1, 22, 43…) [Window: ±3 days] |
| OG002 | Part 2-Arm A, Pexa-Vec (IT) and Cemiplimab | Pexa-Vec will be administered via IT (intratumoral) injection every 2 weeks for 3 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
| OG003 | Part 2-Arm B, Cemiplimab | Cemiplimab will be administered via IV infusion every 3 weeks. At disease progression, Pexa-Vec will be administered via IT (intratumoral) injection every 2 weeks for 3 treatments. Cemiplimab will continue every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
| OG004 | Part 2-Arm C, Pexa-Vec (IV) and Cemiplimab | Pexa-Vec will be administered via IV infusion once per week for 4 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
| OG005 | Part 2-Arm D, Pexa-Vec (IV) and Cemiplimab | Pexa-Vec will be administered via IV infusion once per week for 4 treatments. Cemiplimab will be administered via IV infusion every 3 weeks. Pexastimogene Devacirepvec (Pexa-Vec): Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells Cemiplimab: Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1) |
|
|