Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cancer Research Institute, New York City | OTHER |
| MedImmune LLC | INDUSTRY |
| Targovax ASA | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This is a two-part Phase 1/2 dose escalation and dose expansion study of an Adenovirus Vector (Ad5/3-D24-GMCSF), Expressing GM-CSF (GM-CSF-encoding adenovirus), ONCOS-102, in combination with anti-programmed death ligand-1 (PD-L1) antibody, durvalumab, in adult subjects with peritoneal disease who have failed prior standard chemotherapy and have histologically confirmed epithelial ovarian cancer or metastatic colorectal cancer.
ONCOS-102 will be administered intraperitoneally (IP) at weekly intervals for 6 weeks.
A bolus dose of 300 mg cyclophosphamide (CPO) will be administered intravenously (IV) 1 to 3 days before the first infusion of ONCOS-102. Durvalumab will be administered by IV infusion once every four weeks (Q4W) for a total of 12 four-week cycles.
Phase 1 of the study is a dose escalation phase, which will use a 3+3 design to evaluate the safety of ONCOS-102 monotherapy before initiation of durvalumab and to identify the recommended combination dose (RCD) of a fixed dose of durvalumab (1500 mg) + ONCOS-102 at 2 dose levels (1 x 10^11 viral particles (VPs) and 3 x 10^11 VPs).
Subjects treated at the RCD of 3 x 10^11 VPs ONCOS-102 will be included in the Phase 2 expansion cohort based on their tumor diagnosis.
Phase 2 of the study is the dose expansion phase, which will further explore the safety and anti-tumor activity for the RCD in 2 expansion cohorts with peritoneal disease:
Simon's 2-Stage MINIMAX Design will be used in Phase 2 for Expansion Cohorts 1 and 2. In the first stage, 18 subjects will be enrolled in Cohort 1 and 13 subjects in Cohort 2 (including the 6 subjects at the RCD from the dose escalation phase).
If 5 or more subjects in Cohort 1, or one or more subjects in Cohort 2, demonstrate clinical benefit (defined as percentage of subjects who are not in progression at end of Week 24), 15 additional subjects will be enrolled in Stage 2 of Cohort 1, and 14 additional subjects will be enrolled in Stage 2 of Cohort 2.
The primary endpoint is the percentage of subjects who are not in progression at the end of Week 24 as measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: ONCOS-102 Dose Escalation | Experimental | ONCOS-102, 1 x 10^11 viral particles (VPs) monotherapy for 6 weeks, followed by durvalumab 1500 mg starting on Day 71. A bolus dose of 300 mg cyclophosphamide (CPO) was administered intravenously (IV) 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused intraperitoneally (IP) in a total volume of 500 mL saline (0.9 mg/mL sodium chloride [NaCl] in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose every 4 weeks (Q4W) for 10 cycles, starting on Day 71. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
|
| Cohort B: ONCOS-102 Dose Escalation | Experimental | ONCOS-102, 1 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
|
| Cohort 1: Epithelial Ovarian Cancer |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONCOS-102 | Biological | ONCOS-102 was administered by intraperitoneal infusion at weekly intervals for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Dose Limiting Toxicities (DLTs) | All Adverse events (AEs) were coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version 19.0 and classified by MedDRA system organ class (SOC) and preferred term. The severity of AEs was assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03. Adverse events (AEs) were reported based on clinical laboratory tests, vital signs, physical examinations, and any other medically indicated assessments, including subject interviews, from the time informed consent was signed through 90 days after the last dose of study treatment. TEAEs are those that occurred or worsened after administration of the first dose of study treatment. Deaths within the AE Reporting Period included all deaths that occurred during the study treatment period, or up to 90 days after the administration of the last dose of study drug or initiation of a new treatment. | up to 31 months (90 days after the last dose of study medication). |
| Progression-free Survival (PFS) at Week 24 as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5, 7, 9, and 11 during study treatment, and during on-study follow-up starting 8 weeks after the last disease assessment. Per RECIST 1.1, target lesions were categorized as follows: complete response (CR): disappearance of all target lesions; partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; PD: ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria. PFS was measured from the date of the first dose of study treatment to the date of earliest disease progression or to the date of death, if disease progression does not occur. Per RECIST 1.1, progressive disease (PD) is defined as a ≥ 20% increase in the sum of the longest diameter of target lesions or the development of new lesions. | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression-free Survival (PFS) as Measured by Response Evaluation in Solid Tumors 1.1 (RECIST 1.1) Using Kaplan-Meier Method | Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5, 7, 9, and 11 during study treatment, and during on-study follow-up starting 8 weeks after the last disease assessment. Per RECIST 1.1, target lesions were categorized as follows: complete response (CR): disappearance of all target lesions; partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; PD: ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria. PFS was measured from the date of the first dose of study treatment to the date of earliest disease progression or to the date of death, if disease progression does not occur. Per RECIST 1.1, progressive disease (PD) is defined as a ≥ 20% increase in the sum of the longest diameter of target lesions or the development of new lesions. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Facility | San Diego | California | 92093-0698 | United States | ||
| Research Facility |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
67 subjects were enrolled and 64 received treatment with study therapy.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A: ONCOS-102 Dose Escalation | ONCOS-102, 1 x 10^11 viral particles (VPs) monotherapy for 6 weeks, followed by durvalumab 1500 mg starting on Day 71. A bolus dose of 300 mg cyclophosphamide (CPO) was administered intravenously (IV) 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused intraperitoneally (IP) in a total volume of 500 mL saline (0.9 mg/mL sodium chloride [NaCl] in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose every 4 weeks (Q4W) for 10 cycles, starting on Day 71. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. . |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 10, 2022 | Aug 4, 2022 |
Not provided
Not provided
The Phase 1 cohorts were enrolled sequentially. In Phase 2, the two expansion cohorts are enrolled in parallel.
Not provided
Not provided
Not provided
Not provided
ONCOS-102, 3 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
|
| Cohort 2: Metastatic Colorectal Cancer | Experimental | ONCOS-102, 3 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
|
|
| Durvalumab | Drug | Durvalumab was administered by IV infusion once every four weeks for a total of 10 (Cohort A) or 12 four-week cycles. |
|
|
| Cyclophosphamide | Drug | A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. |
|
|
| Up to 29 months |
| Objective Response Rate as Measured by as Measured by Response Evaluation in Solid Tumors 1.1 (RECIST 1.1) | Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5, 7, 9, and 11 during study treatment, and during on-study follow-up starting 8 weeks after the last disease assessment. Per RECIST 1.1, target lesions were categorized as follows: complete response (CR): disappearance of all target lesions; partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; PD: ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria. | Up to 15 months |
| Progression-free Survival (PFS) at Week 24 as Measured by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) | Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5, 7, 9, and 11 during study treatment, and during on-study follow-up starting 8 weeks after the last disease assessment. Per irRECIST, measurable lesions were categorized as follows: immune-related complete response (irCR): Complete disappearance of all target lesions; immune-related partial response (irPR): ≥ 30% decrease from baseline in the Total Measurable Tumor Burden (TMTB); immune-related progressive disease (irPD): ≥ 20% increase from nadir in TMTB; immune-related stable disease (irSD): not meeting above criteria. PFS was measured from the date of the first dose of study treatment to the date of earliest disease progression or to the date of death, if disease progression does not occur. Per irRECIST, irPD is defined as a ≥ 20% increase from nadir in the TMTB. | Up to 24 Weeks |
| Median Progression-free Survival (PFS) by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) as Estimated Using the Kaplan-Meier Method | Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5,7, 9, and 11 during study treatment, and during on-study follow-up starting 8 weeks after the last disease assessment. Per irRECIST, measurable lesions were categorized as follows: immune-related complete response (irCR): Complete disappearance of all target lesions; immune-related partial response (irPR): ≥ 30% decrease from baseline in the total measurable tumor burden (TMTB); immune-related progressive disease (irPD): ≥ 20% increase from nadir in TMTB; immune-related stable disease (irSD): not meeting above criteria. PFS was measured from the date of the first dose of study treatment to the date of earliest disease progression or to the date of death, if disease progression does not occur. Per irRECIST, irPD is defined as a ≥ 20% increase from nadir in the TMTB. | Up to 39 months |
| Objective Response Rate as Measured by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) | Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5, 7, 9, and 11 during study treatment, and during on-study follow-up starting 8 weeks after the last disease assessment. Per irRECIST, measurable lesions were categorized as follows: immune-related complete response (irCR): Complete disappearance of all target lesions; immune-related partial response (irPR): ≥ 30% decrease from baseline in the total measurable tumor burden (TMTB); immune-related progressive disease (irPD): ≥ 20% increase from nadir in TMTB; immune-related stable disease (irSD): not meeting above criteria. | Up to 15 months |
| Median Overall Survival (OS) as Estimated Using the Kaplan-Meier Method | After completion of treatment, all subjects were followed for survival every 6 months up to 3 years following initiation of study treatment or until June 25, 2022 when all post-study follow-up was completed. OS was measured from the date of the first dose of study treatment to the date of death or last follow-up (June 25, 2022 when the last follow-up data was collected or earlier). Subjects lost to follow-up are censored on the date when they were last known to be alive. | Up to 39 months |
| Miami |
| Florida |
| 33136 |
| United States |
| Research Facility | Buffalo | New York | 14263 | United States |
| Research Facility | New York | New York | 10065 | United States |
| Research Facility | Toledo | Ohio | 43614 | United States |
| Research Facility | Charlottesville | Virginia | 22903 | United States |
| FG001 | Cohort B: ONCOS-102 Dose Escalation | ONCOS-102, 1 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
| FG002 | Cohort 1: Epithelial Ovarian Cancer | ONCOS-102, 3 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
| FG003 | Cohort 2: Metastatic Colorectal Cancer | ONCOS-102, 3 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
|
| COMPLETED | Completed includes all subjects who completed 12 cycles of treatment. |
|
| NOT COMPLETED |
|
|
All subjects who received at least one dose of study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A: ONCOS-102 Dose Escalation | ONCOS-102, 1 x 10^11 viral particles (VPs) monotherapy for 6 weeks, followed by durvalumab 1500 mg starting on Day 71. A bolus dose of 300 mg cyclophosphamide (CPO) was administered intravenously (IV) 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused intraperitoneally (IP) in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose every 4 weeks (Q4W) for 10 cycles, starting on Day 71. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. . |
| BG001 | Cohort BL ONCOS-102 Dose Escalation | ONCOS-102, 1 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
| BG002 | Cohort 1: Epithelial Ovarian Cancer | ONCOS-102, 3 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
| BG003 | Cohort 2: Metastatic Colorectal Cancer | ONCOS-102, 3 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Dose Limiting Toxicities (DLTs) | All Adverse events (AEs) were coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version 19.0 and classified by MedDRA system organ class (SOC) and preferred term. The severity of AEs was assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03. Adverse events (AEs) were reported based on clinical laboratory tests, vital signs, physical examinations, and any other medically indicated assessments, including subject interviews, from the time informed consent was signed through 90 days after the last dose of study treatment. TEAEs are those that occurred or worsened after administration of the first dose of study treatment. Deaths within the AE Reporting Period included all deaths that occurred during the study treatment period, or up to 90 days after the administration of the last dose of study drug or initiation of a new treatment. | All subjects who received at least one dose of study medication. | Posted | Count of Participants | Participants | up to 31 months (90 days after the last dose of study medication). |
|
|
| |||||||||||||||||||||||||||
| Primary | Progression-free Survival (PFS) at Week 24 as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5, 7, 9, and 11 during study treatment, and during on-study follow-up starting 8 weeks after the last disease assessment. Per RECIST 1.1, target lesions were categorized as follows: complete response (CR): disappearance of all target lesions; partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; PD: ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria. PFS was measured from the date of the first dose of study treatment to the date of earliest disease progression or to the date of death, if disease progression does not occur. Per RECIST 1.1, progressive disease (PD) is defined as a ≥ 20% increase in the sum of the longest diameter of target lesions or the development of new lesions. | All subjects who received at least one dose of study medication. | Posted | Count of Participants | Participants | Up to 24 weeks |
| |||||||||||||||||||||||||||||
| Secondary | Median Progression-free Survival (PFS) as Measured by Response Evaluation in Solid Tumors 1.1 (RECIST 1.1) Using Kaplan-Meier Method | Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5, 7, 9, and 11 during study treatment, and during on-study follow-up starting 8 weeks after the last disease assessment. Per RECIST 1.1, target lesions were categorized as follows: complete response (CR): disappearance of all target lesions; partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; PD: ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria. PFS was measured from the date of the first dose of study treatment to the date of earliest disease progression or to the date of death, if disease progression does not occur. Per RECIST 1.1, progressive disease (PD) is defined as a ≥ 20% increase in the sum of the longest diameter of target lesions or the development of new lesions. | All subjects who received at least one dose of study medication. | Posted | Median | 95% Confidence Interval | months | Up to 29 months |
| ||||||||||||||||||||||||||||
| Secondary | Objective Response Rate as Measured by as Measured by Response Evaluation in Solid Tumors 1.1 (RECIST 1.1) | Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5, 7, 9, and 11 during study treatment, and during on-study follow-up starting 8 weeks after the last disease assessment. Per RECIST 1.1, target lesions were categorized as follows: complete response (CR): disappearance of all target lesions; partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; PD: ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria. | All subjects who received at least one dose of study medication and had a baseline and at least one post-baseline disease assessment. | Posted | Count of Participants | Participants | Up to 15 months |
| |||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) at Week 24 as Measured by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) | Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5, 7, 9, and 11 during study treatment, and during on-study follow-up starting 8 weeks after the last disease assessment. Per irRECIST, measurable lesions were categorized as follows: immune-related complete response (irCR): Complete disappearance of all target lesions; immune-related partial response (irPR): ≥ 30% decrease from baseline in the Total Measurable Tumor Burden (TMTB); immune-related progressive disease (irPD): ≥ 20% increase from nadir in TMTB; immune-related stable disease (irSD): not meeting above criteria. PFS was measured from the date of the first dose of study treatment to the date of earliest disease progression or to the date of death, if disease progression does not occur. Per irRECIST, irPD is defined as a ≥ 20% increase from nadir in the TMTB. | All subjects who received at least one dose of study medication and had a baseline and at least one post-baseline disease assessment. | Posted | Count of Participants | Participants | Up to 24 Weeks |
| |||||||||||||||||||||||||||||
| Secondary | Median Progression-free Survival (PFS) by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) as Estimated Using the Kaplan-Meier Method | Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5,7, 9, and 11 during study treatment, and during on-study follow-up starting 8 weeks after the last disease assessment. Per irRECIST, measurable lesions were categorized as follows: immune-related complete response (irCR): Complete disappearance of all target lesions; immune-related partial response (irPR): ≥ 30% decrease from baseline in the total measurable tumor burden (TMTB); immune-related progressive disease (irPD): ≥ 20% increase from nadir in TMTB; immune-related stable disease (irSD): not meeting above criteria. PFS was measured from the date of the first dose of study treatment to the date of earliest disease progression or to the date of death, if disease progression does not occur. Per irRECIST, irPD is defined as a ≥ 20% increase from nadir in the TMTB. | All subjects who received at least one dose of study medication. | Posted | Median | 95% Confidence Interval | months | Up to 39 months |
| ||||||||||||||||||||||||||||
| Secondary | Objective Response Rate as Measured by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) | Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 28 days before the first dose of study treatment), at cycles 3, 5, 7, 9, and 11 during study treatment, and during on-study follow-up starting 8 weeks after the last disease assessment. Per irRECIST, measurable lesions were categorized as follows: immune-related complete response (irCR): Complete disappearance of all target lesions; immune-related partial response (irPR): ≥ 30% decrease from baseline in the total measurable tumor burden (TMTB); immune-related progressive disease (irPD): ≥ 20% increase from nadir in TMTB; immune-related stable disease (irSD): not meeting above criteria. | All subjects who received at least one dose of study medication and had a baseline and at least one post-baseline disease assessment. | Posted | Count of Participants | Participants | Up to 15 months |
| |||||||||||||||||||||||||||||
| Secondary | Median Overall Survival (OS) as Estimated Using the Kaplan-Meier Method | After completion of treatment, all subjects were followed for survival every 6 months up to 3 years following initiation of study treatment or until June 25, 2022 when all post-study follow-up was completed. OS was measured from the date of the first dose of study treatment to the date of death or last follow-up (June 25, 2022 when the last follow-up data was collected or earlier). Subjects lost to follow-up are censored on the date when they were last known to be alive. | All subjects who received at least one dose of study medication. | Posted | Median | 95% Confidence Interval | months | Up to 39 months |
|
AEs were collected up to 31 months (90 days after the last dose of study medication). All AEs occurring between the signing of informed consent and the off-study date (i.e., through 90 days after the last dose of study treatment) are documented, regardless of a causal relationship to study drug. All-cause mortality includes all deaths which were reported up for up to 39 months.
AEs that occur or worsen in severity after the first dose of study treatment are considered treatment emergent (i.e., TEAEs). AE documentation includes onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A: ONCOS-102 Dose Escalation | ONCOS-102, 1 x 10^11 viral particles (VPs) monotherapy for 6 weeks, followed by durvalumab 1500 mg starting on Day 71. A bolus dose of 300 mg cyclophosphamide (CPO) was administered intravenously (IV) 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused intraperitoneally (IP) in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose every 4 weeks (Q4W) for 10 cycles, starting on Day 71. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. . | 3 | 4 | 3 | 4 | 4 | 4 |
| EG001 | Cohort B ONCOS-102 Dose Escalation | ONCOS-102, 1 x 10^11 VPs + durvalumab 1500 mg starting on day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. | 3 | 5 | 3 | 5 | 5 | 5 |
| EG002 | Cohort 1: Epithelial Ovarian Cancer | ONCOS-102, 3 x 10^11 VPs + durvalumab 1500 mg starting on day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. | 16 | 19 | 9 | 19 | 19 | 19 |
| EG003 | Cohort 2: Metastatic Colorectal Cancer | ONCOS-102, 3 x 10^11 VPs + durvalumab 1500 mg starting on day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. | 28 | 36 | 22 | 36 | 36 | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocarditis | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Infusion site erythema | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Blood culture positive | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Metastases to the ovary | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cyanosis | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Thyroiditis | Endocrine disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal distention | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Anal ulcer | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rectal tenesmus | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Catheter site related reaction | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Complication associated with device | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Early satiety | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Infusion site pruritus | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Infusion site rash | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Infusion site swelling | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Mass | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Medical device site discharge | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Corona virus infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Carbohydrate antigen 125 increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA (19.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Migraine with aura | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Urine flow decreased | Renal and urinary disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pelvic discomfort | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Infusion site erythema | General disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Skipper | Ludwig Institute for Cancer Research | 12124501539 | jskipper@lcr.org |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 26, 2021 | Aug 4, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D010051 | Ovarian Neoplasms |
| D001063 | Appendiceal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002430 | Cecal Neoplasms |
| D002429 | Cecal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000613593 | durvalumab |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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 |
|
| OG003 | Cohort 2: Metastatic Colorectal Cancer | ONCOS-102, 3 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
|
| Treatment-related Adverse Event (TRAE) |
|
|
| Serious Adverse Event (SAE) |
|
|
| Treatment-related SAE |
|
|
| Dose-limiting Toxicity (DLT) |
|
|
| Death |
|
|
| DLTs |
|
|
| OG001 | Cohort B: ONCOS-102 Dose Escalation | ONCOS-102, 1 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
| OG002 | Cohort 1: Epithelial Ovarian Cancer | ONCOS-102, 3 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
| OG003 | Cohort 2: Metastatic Colorectal Cancer | ONCOS-102, 3 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
|
|
| OG001 | Cohort B: ONCOS-102 Dose Escalation | ONCOS-102, 1 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
| OG002 | Cohort 1: Epithelial Ovarian Cancer | ONCOS-102, 3 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
| OG003 | Cohort 2: Metastatic Colorectal Cancer | ONCOS-102, 3 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
|
|
| OG001 | Cohort B: ONCOS-102 Dose Escalation | ONCOS-102, 1 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
| OG002 | Cohort 1: Epithelial Ovarian Cancer | ONCOS-102, 3 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
| OG003 | Cohort 2: Metastatic Colorectal Cancer | ONCOS-102, 3 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
|
|
| OG001 | Cohort B: ONCOS-102 Dose Escalation | ONCOS-102, 1 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
| OG002 | Cohort 1: Epithelial Ovarian Cancer | ONCOS-102, 3 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
| OG003 | Cohort 2: Metastatic Colorectal Cancer | ONCOS-102, 3 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
|
|
| OG001 | Cohort B: ONCOS-102 Dose Escalation | ONCOS-102, 1 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
| OG002 | Cohort 1: Epithelial Ovarian Cancer | ONCOS-102, 3 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
| OG003 | Cohort 2: Metastatic Colorectal Cancer | ONCOS-102, 3 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
|
|
| OG001 | Cohort B: ONCOS-102 Dose Escalation | ONCOS-102, 1 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
| OG002 | Cohort 1: Epithelial Ovarian Cancer | ONCOS-102, 3 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
| OG003 | Cohort 2: Colorectal Cancer | ONCOS-102, 3 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
|
|
| OG001 |
| Cohort B: ONCOS-102 Dose Escalation |
ONCOS-102, 1 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
| OG002 | Cohort 1: Epithelial Ovarian Cancer | ONCOS-102, 3 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
| OG003 | Cohort 2: Metastatic Colorectal Cancer | ONCOS-102, 3 x 10^11 VPs + durvalumab 1500 mg starting on Day 15. A bolus dose of 300 mg cyclophosphamide (CPO) was administered IV 1 to 3 days before the first infusion of ONCOS-102. ONCOS-102 was infused IP in a total volume of 500 mL saline (0.9 mg/mL NaCl in water for injection) by gravity feed or per institutional procedures for IP infusions. ONCOS-102 was to be administered weekly for a total of 6 weeks, starting on Day 1. Durvalumab was administered as an intravenous (IV) infusion at a fixed dose of 1500 mg in either 0.9% (w/v) saline or dextrose Q4W for 12 cycles, starting on Day 15. Optional durvalumab treatment extension beyond the initial 12-cycle treatment period was allowed for subjects who complete the 12-cycle treatment period with Stable Disease or better. |
|
|