Advanced/Metastatic Melanoma
Conditions
Keywords
programmed cell death 1 (PD-1, PD1), programmed cell death ligand 1 (PD-L1, PDL1), programmed cell death ligand 2 (PD-L2, PDL2), Coxsackievirus A21, Intracellular Adhesion Molecule-1 (ICAM-1)
Brief summary
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.
Interventions
BIOLOGICALGebasaxturev IV
Administered as an IV infusion of 1 X 10\^9 TCID50
BIOLOGICALGebasaxturev ITu
Administered as an ITu injection of 3 X 10\^8 TCID50
DRUGPembrolizumab
Administered as an IV infusion of 200 mg
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: * At least 1 cutaneous or subcutaneous lesion that is amenable to IT injection and biopsy and measurable per RECIST 1.1 * At least 1 distant and/or discrete noninjected lesion that is amenable to biopsy and measurable per RECIST 1.1 * 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: * Must have Cluster of Differentiation 4 (CD4)+ T-cell count \>350 cells/mm\^3 at time of screening * Must have achieved and maintained virologic suppression * Must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks prior to study entry * The combination ART regimen must not contain any antiretroviral medication other than abacavir, dolutegravir, emtricitabine, lamivudine, raltegravir, rilpivirine, or tenofovir
Exclusion criteria
* Has had chemotherapy, definitive radiation, or biological cancer therapy or an investigational agent or investigational device within 4 weeks prior to the first dose of study intervention or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier * Has ocular melanoma * Has radiographic evidence of major blood vessel infiltration * Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug * Has an active autoimmune disease that has required systemic treatment in the past 2 years except vitiligo or resolved childhood asthma/atopy * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the study requirements * Has undergone allogeneic hematopoietic stem cell transplantation within the last 5 years * Has not fully recovered from major surgery without significant detectable infection * Active cardiovascular disease (\<6 months prior to enrollment), myocardial infarction (\<6 months prior to enrollment), unstable angina, congestive heart failure or serious cardiac arrhythmia requiring medication * Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or other agents such as cytotoxic T-lymphocyte-associated protein-4 (CTLA-4), OX-40, Cluster of Differentiation 137 (CD137) * Has received a live vaccine within 30 days prior to the first dose of study drug * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy in excess of replacement doses or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug * Has a known additional malignancy that is progressing or has required active treatment within the past 2 years * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has hypersensitivity to pembrolizumab and/or any of its excipients * Has hypersensitivity to gebasaxturev or any of its excipients * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis * Has an active infection requiring systemic therapy * Has a known history of Hepatitis B or known active Hepatitis C virus infection * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator * Has had an allogenic tissue/solid organ transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Up to ~ 35 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DOR) | Up to ~ 35 months | 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. |
| Objective Response Rate (ORR) Per RECIST 1.1, as Assessed by the Investigator | Up to ~ 35 months | 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. |
| Progression Free Survival (PFS) RECIST 1.1, as Assessed by the Investigator | Up to ~ 35 months | 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. |
| Progression Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR | Up to ~ 35 months | 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. |
| Overall Survival (OS) | Up to ~ 35 months | OS is the time from randomization to death due to any cause. |
| Percentage of Participants Who Experienced an Adverse Event (AE) | Up to ~ 37 months | 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. |
| Percentage of Participants Who Discontinued Study Drug Due to an AE | Up to ~ 27 months | 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. |
| Duration of Response (DOR) Per RECIST 1.1, as Assessed by the Investigator | Up to ~ 35 months | 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. |
Countries
Australia, Chile, France, Germany, Israel, Italy, Norway, South Africa, South Korea, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 28 |
| 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). | 28 |
| 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). | 29 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 13 | 12 | 7 |
| Overall Study | Participation in Study Terminated by Sponsor | 12 | 14 | 18 |
| Overall Study | Physician Decision | 1 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 3 |
Baseline characteristics
| Characteristic | Intratumoral (ITu) Gebasaxturev + IV Pembrolizumab | Total | Intravenous (IV) Gebasaxturev + IV Pembrolizumab | Pembrolizumab IV |
|---|---|---|---|---|
| Age, Continuous | 58.3 Years STANDARD_DEVIATION 13.6 | 61.2 Years STANDARD_DEVIATION 12.2 | 64.8 Years STANDARD_DEVIATION 10.5 | 60.5 Years STANDARD_DEVIATION 11.9 |
| Cancer M Staging at Baseline M1a | 9 Participants | 25 Participants | 7 Participants | 9 Participants |
| Cancer M Staging at Baseline M1b | 3 Participants | 14 Participants | 6 Participants | 5 Participants |
| Cancer M Staging at Baseline M1c | 14 Participants | 35 Participants | 12 Participants | 9 Participants |
| Cancer M Staging at Baseline M1d | 1 Participants | 3 Participants | 1 Participants | 1 Participants |
| Cancer M Staging at Baseline Missing | 1 Participants | 8 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 11 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 72 Participants | 25 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 8 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 73 Participants | 23 Participants | 26 Participants |
| Sex: Female, Male Female | 10 Participants | 29 Participants | 8 Participants | 11 Participants |
| Sex: Female, Male Male | 18 Participants | 56 Participants | 20 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 14 / 28 | 12 / 28 | 9 / 29 |
| other Total, other adverse events | 27 / 28 | 27 / 28 | 22 / 26 |
| serious Total, serious adverse events | 8 / 28 | 5 / 28 | 4 / 26 |
Outcome results
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.
Time frame: Up to ~ 35 months
Population: All allocated participants included in the treatment group to which they were allocated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intravenous (IV) Gebasaxturev + IV Pembrolizumab | 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) | 46.4 Percentage of Participants |
| Intratumoral (ITu) Gebasaxturev + IV Pembrolizumab | 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) | 39.3 Percentage of Participants |
| Pembrolizumab IV | 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) | 34.5 Percentage of Participants |
p-value: 0.181290% CI: [-9.5, 32.5]Stratified Miettinen & Nurminen method
p-value: 0.354890% CI: [-16.2, 25.5]Stratified Miettinen & Nurminen method
90% CI: [-14.6, 28.2]
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.
Time frame: Up to ~ 35 months
Population: All allocated participants included in the treatment group to which they were allocated.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous (IV) Gebasaxturev + IV Pembrolizumab | Duration of Response (DOR) | NA Months |
| Intratumoral (ITu) Gebasaxturev + IV Pembrolizumab | Duration of Response (DOR) | NA Months |
| Pembrolizumab IV | Duration of Response (DOR) | NA Months |
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.
Time frame: Up to ~ 35 months
Population: All allocated participants included in the treatment group to which they were allocated.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous (IV) Gebasaxturev + IV Pembrolizumab | Duration of Response (DOR) Per RECIST 1.1, as Assessed by the Investigator | NA Months |
| Intratumoral (ITu) Gebasaxturev + IV Pembrolizumab | Duration of Response (DOR) Per RECIST 1.1, as Assessed by the Investigator | NA Months |
| Pembrolizumab IV | Duration of Response (DOR) Per RECIST 1.1, as Assessed by the Investigator | NA Months |
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.
Time frame: Up to ~ 35 months
Population: All allocated participants included in the treatment group to which they were allocated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intravenous (IV) Gebasaxturev + IV Pembrolizumab | Objective Response Rate (ORR) Per RECIST 1.1, as Assessed by the Investigator | 39.3 Percentage of Participants |
| Intratumoral (ITu) Gebasaxturev + IV Pembrolizumab | Objective Response Rate (ORR) Per RECIST 1.1, as Assessed by the Investigator | 39.3 Percentage of Participants |
| Pembrolizumab IV | Objective Response Rate (ORR) Per RECIST 1.1, as Assessed by the Investigator | 41.4 Percentage of Participants |
90% CI: [-23.1, 19.2]
90% CI: [-23.1, 19.2]
90% CI: [-21.2, 21.2]
Secondary
Overall Survival (OS)
OS is the time from randomization to death due to any cause.
Time frame: Up to ~ 35 months
Population: All allocated participants included in the treatment group to which they were allocated.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous (IV) Gebasaxturev + IV Pembrolizumab | Overall Survival (OS) | 17.5 Months |
| Intratumoral (ITu) Gebasaxturev + IV Pembrolizumab | Overall Survival (OS) | 24.1 Months |
| Pembrolizumab IV | Overall Survival (OS) | NA Months |
95% CI: [0.71, 3.79]
95% CI: [0.47, 2.68]
95% CI: [0.64, 3.02]
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.
Time frame: Up to ~ 27 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intravenous (IV) Gebasaxturev + IV Pembrolizumab | Percentage of Participants Who Discontinued Study Drug Due to an AE | 14.3 Percentage of Participants |
| Intratumoral (ITu) Gebasaxturev + IV Pembrolizumab | Percentage of Participants Who Discontinued Study Drug Due to an AE | 7.1 Percentage of Participants |
| Pembrolizumab IV | Percentage of Participants Who Discontinued Study Drug Due to an AE | 3.8 Percentage of Participants |
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.
Time frame: Up to ~ 37 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intravenous (IV) Gebasaxturev + IV Pembrolizumab | Percentage of Participants Who Experienced an Adverse Event (AE) | 100 Percentage of Participants |
| Intratumoral (ITu) Gebasaxturev + IV Pembrolizumab | Percentage of Participants Who Experienced an Adverse Event (AE) | 100 Percentage of Participants |
| Pembrolizumab IV | Percentage of Participants Who Experienced an Adverse Event (AE) | 84.6 Percentage of Participants |
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.
Time frame: Up to ~ 35 months
Population: All allocated participants included in the treatment group to which they were allocated.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous (IV) Gebasaxturev + IV Pembrolizumab | Progression Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR | 12.7 Months |
| Intratumoral (ITu) Gebasaxturev + IV Pembrolizumab | Progression Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR | 7.3 Months |
| Pembrolizumab IV | Progression Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR | 8.6 Months |
95% CI: [0.5, 2.27]
95% CI: [0.51, 2.29]
95% CI: [0.5, 2.04]
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.
Time frame: Up to ~ 35 months
Population: All allocated participants included in the treatment group to which they were allocated.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intravenous (IV) Gebasaxturev + IV Pembrolizumab | Progression Free Survival (PFS) RECIST 1.1, as Assessed by the Investigator | 4.6 Months |
| Intratumoral (ITu) Gebasaxturev + IV Pembrolizumab | Progression Free Survival (PFS) RECIST 1.1, as Assessed by the Investigator | 6.5 Months |
| Pembrolizumab IV | Progression Free Survival (PFS) RECIST 1.1, as Assessed by the Investigator | 15.4 Months |
95% CI: [0.7, 3.02]
95% CI: [0.62, 2.68]
95% CI: [0.6, 2.22]