Trial Outcomes & Findings for Olvi-Vec Oncolytic Immunotherapy in Patients With Recurrent or Refractory Ovarian Cancer (NCT NCT02759588)
NCT ID: NCT02759588
Last Updated: 2026-06-12
Results Overview
Determine safety and tolerability of administering 2 consecutive doses of Olvi-Vec via intraperitoneal catheter by the evaluation of the number of participants with related treatment-emergent adverse events (type, frequency, and severity) as assessed by CTCAE 4.03.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
46 participants
Primary outcome timeframe
Change from baseline during Treatment and for 30 days following last dose over average of 2 years.
Results posted on
2026-06-12
Participant Flow
Participants were enrolled at 2 clinical sites in the United States. Enrollment into cohorts based on order of consented and eligible participants into an open cohort.
Participant milestones
| Measure |
Phase 1b - Cohort 1 Participants
Participants treated in Cohort 1 received 2 consecutive intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu.
|
Phase 1b - Cohort 2 Participants
Participants treated in Cohort 2 received 2 consecutive intraperitoneal infusions of Olvi-Vec at 1 x 10e10 pfu
|
Phase 1b - Cohort 3 Participants
Participants treated in Cohort 3 received 2 consecutive intraperitoneal infusions of Olvi-Vec at 2.5 x 10e10 pfu.
|
Phase 2 - Cohort A Participants
Participants treated in Cohort A received 2 consecutive intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu and may or may not have received platinum-doublet chemotherapy with or without bevacizumab.
|
Phase 2 - Cohort C Participants
Participants treated in Cohort C received 2 consecutive intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu and may or may not have received platinum-doublet chemotherapy with or without bevacizumab.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
1
|
22
|
12
|
|
Overall Study
COMPLETED
|
1
|
1
|
0
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
1
|
20
|
11
|
Reasons for withdrawal
| Measure |
Phase 1b - Cohort 1 Participants
Participants treated in Cohort 1 received 2 consecutive intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu.
|
Phase 1b - Cohort 2 Participants
Participants treated in Cohort 2 received 2 consecutive intraperitoneal infusions of Olvi-Vec at 1 x 10e10 pfu
|
Phase 1b - Cohort 3 Participants
Participants treated in Cohort 3 received 2 consecutive intraperitoneal infusions of Olvi-Vec at 2.5 x 10e10 pfu.
|
Phase 2 - Cohort A Participants
Participants treated in Cohort A received 2 consecutive intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu and may or may not have received platinum-doublet chemotherapy with or without bevacizumab.
|
Phase 2 - Cohort C Participants
Participants treated in Cohort C received 2 consecutive intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu and may or may not have received platinum-doublet chemotherapy with or without bevacizumab.
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
5
|
4
|
1
|
18
|
10
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Olvi-Vec Oncolytic Immunotherapy in Patients With Recurrent or Refractory Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Phase 1b - Cohort 1 Participants
n=6 Participants
Participants treated in Cohort 1 received 2 consecutive intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu.
|
Phase 1b - Cohort 2 Participants
n=5 Participants
Participants treated in Cohort 2 received 2 consecutive intraperitoneal infusions of Olvi-Vec at 1 x 10e10 pfu.
|
Phase 1b - Cohort 3 Participants
n=1 Participants
Participants treated in Cohort 3 received 2 consecutive intraperitoneal infusions of Olvi-Vec at 2.5 x 10e10 pfu.
|
Phase 2 - Cohort A Participants
n=22 Participants
Participants received 2 consecutive intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu and received platinum-doublet chemotherapy with or without bevacizumab.
|
Phase 2 - Cohort C Participants
n=12 Participants
Participants received 2 consecutive intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu and received platinum-doublet chemotherapy with or without bevacizumab.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
15 Participants
n=265 Participants
|
8 Participants
n=568 Participants
|
28 Participants
n=22 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
7 Participants
n=265 Participants
|
4 Participants
n=568 Participants
|
18 Participants
n=22 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
22 Participants
n=265 Participants
|
12 Participants
n=568 Participants
|
46 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
4 Participants
n=568 Participants
|
7 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
19 Participants
n=265 Participants
|
8 Participants
n=568 Participants
|
39 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
1 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
1 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
1 Participants
n=22 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
21 Participants
n=265 Participants
|
11 Participants
n=568 Participants
|
43 Participants
n=22 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
1 Participants
n=568 Participants
|
1 Participants
n=22 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=9 Participants
|
5 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
22 Participants
n=265 Participants
|
12 Participants
n=568 Participants
|
46 Participants
n=22 Participants
|
|
Platinum Disease
Platinum-resistant ovarian cancer
|
4 Participants
n=9 Participants
|
3 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
14 Participants
n=265 Participants
|
5 Participants
n=568 Participants
|
27 Participants
n=22 Participants
|
|
Platinum Disease
Platinum-refractory ovarian cancer
|
2 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
6 Participants
n=265 Participants
|
7 Participants
n=568 Participants
|
17 Participants
n=22 Participants
|
|
Platinum Disease
Intermediate platinum-sensitive ovarian cancer
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
2 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
2 Participants
n=22 Participants
|
PRIMARY outcome
Timeframe: Change from baseline during Treatment and for 30 days following last dose over average of 2 years.Population: Participants who received at least 1 dose of Olvi-Vec via intraperitoneal catheter.
Determine safety and tolerability of administering 2 consecutive doses of Olvi-Vec via intraperitoneal catheter by the evaluation of the number of participants with related treatment-emergent adverse events (type, frequency, and severity) as assessed by CTCAE 4.03.
Outcome measures
| Measure |
Phase 1b - Cohort 1 Participants
n=5 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu.
|
Phase 1b - Cohort 2 Participants
n=5 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 1 x 10e10 pfu.
|
Phase 1b - Cohort 3 Participants
n=1 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 2.5 x 10e10 pfu.
|
Phase 2 - Cohort C Platinum-refractory Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu and received chemotherapy with or without bevacizumab.
|
|---|---|---|---|---|
|
Number of Participants With Related Treatment-emergent Adverse Event [Safety and Tolerability] (Phase 1b)
Participants with Mild, Moderate or Severe related TEAEs
|
5 Participants
|
5 Participants
|
1 Participants
|
—
|
|
Number of Participants With Related Treatment-emergent Adverse Event [Safety and Tolerability] (Phase 1b)
Participants with life-threatening related TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Related Treatment-emergent Adverse Event [Safety and Tolerability] (Phase 1b)
Participants with related TEAEs with outcome of death
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: For participants enrolled in the Phase 2 portion, outcome is from the date of starting chemotherapy until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to 24 months.Population: Evaluable participants who had at least one post-treatment imaging scan.
Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Phase 1b - Cohort 1 Participants
n=7 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu.
|
Phase 1b - Cohort 2 Participants
n=2 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 1 x 10e10 pfu.
|
Phase 1b - Cohort 3 Participants
n=2 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 2.5 x 10e10 pfu.
|
Phase 2 - Cohort C Platinum-refractory Participants
n=7 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu and received chemotherapy with or without bevacizumab.
|
|---|---|---|---|---|
|
Progression-free Survival Following Treatment in Participants Enrolled in the Phase 2 Portion of Study With Platinum-resistant or Platinum-refractory Ovarian Cancer.
|
10 Number of months
Interval 4.0 to
NA = Not reached
|
10.3 Number of months
Interval 4.3 to
NA = Not reached
|
11 Number of months
Interval 5.2 to
NA = Not reached
|
10.1 Number of months
Interval 1.1 to 11.5
|
PRIMARY outcome
Timeframe: Assessed pre-treatment, during treatment at 2- to 3-week intervals and post-treatment assessed up to 24 months.Population: Percent of participants
To assess anti-tumor response by Overall Response Rate by Tumor Marker Cancer Antigen-125 (CA-125) for participants who were enrolled in the Phase 2 portion of this study with platinum-resistant or platinum-refractory ovarian cancer.
Outcome measures
| Measure |
Phase 1b - Cohort 1 Participants
n=10 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu.
|
Phase 1b - Cohort 2 Participants
n=3 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 1 x 10e10 pfu.
|
Phase 1b - Cohort 3 Participants
n=4 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 2.5 x 10e10 pfu.
|
Phase 2 - Cohort C Platinum-refractory Participants
n=7 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu and received chemotherapy with or without bevacizumab.
|
|---|---|---|---|---|
|
Overall Response Rate (ORR) by Tumor Marker Cancer Antigen-125 (CA-125) for Participants Enrolled in the Phase 2 Portion of Study With Platinum-resistant or Platinum-refractory Ovarian Cancer
|
80.0 Percent of participants
|
66.7 Percent of participants
|
75.0 Percent of participants
|
85.7 Percent of participants
|
PRIMARY outcome
Timeframe: For evaluable participants enrolled in the Phase 2 portion of this study with platinum-resistant or platinum-refractory ovarian cancer who were assessed at pre-treatment, during treatment at 6- to 12-week intervals and post-treatment up to 24 months.Population: Evaluable participants with at least one post-treatment imaging scan.
To assess anti-tumor response by Overall Response Rate (ORR) defined as disease control rate (DCR = CR + PR + SD≥15 weeks) by RECIST 1.1 criteria: Complete Response (CR) is a disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions; stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to quality for progressive disease; Progressive Disease (PD) is at least a 20% increase in sum of longest diameter of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions.
Outcome measures
| Measure |
Phase 1b - Cohort 1 Participants
n=8 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu.
|
Phase 1b - Cohort 2 Participants
n=3 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 1 x 10e10 pfu.
|
Phase 1b - Cohort 3 Participants
n=3 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 2.5 x 10e10 pfu.
|
Phase 2 - Cohort C Platinum-refractory Participants
n=5 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu and received chemotherapy with or without bevacizumab.
|
|---|---|---|---|---|
|
Overall Response Rate (ORR) by RECIST 1.1 for Participants Enrolled in the Phase 2 Portion of the Study With Platinum-resistant or Platinum-refractory Ovarian Cancer
|
87.5 Percent of participants
|
33.3 Percent of participants
|
33.3 Percent of participants
|
60.0 Percent of participants
|
SECONDARY outcome
Timeframe: Assessed post-treatment at 6 to 12 week intervals or until disease progression or death from any cause, whichever comes first, assessed up to 24 months.Population: Participants who had at least one post-treatment imaging scan.
Participants enrolled in the Phase 1b study were assessed for best overall response to treatment with therapeutic intent by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. criteria: Complete Response (CR) is a disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions; stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to quality for progressive disease; Progressive Disease (PD) is at least a 20% increase in sum of longest diameter of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions.
Outcome measures
| Measure |
Phase 1b - Cohort 1 Participants
n=2 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu.
|
Phase 1b - Cohort 2 Participants
n=1 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 1 x 10e10 pfu.
|
Phase 1b - Cohort 3 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 2.5 x 10e10 pfu.
|
Phase 2 - Cohort C Platinum-refractory Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu and received chemotherapy with or without bevacizumab.
|
|---|---|---|---|---|
|
Evaluation of Tumor Response to Treatment for Participants Enrolled in the Phase 1b Portion of This Study
Complete Response
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Evaluation of Tumor Response to Treatment for Participants Enrolled in the Phase 1b Portion of This Study
Partial Response
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Evaluation of Tumor Response to Treatment for Participants Enrolled in the Phase 1b Portion of This Study
Stable Disease
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Evaluation of Tumor Response to Treatment for Participants Enrolled in the Phase 1b Portion of This Study
Progressive Disease
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Evaluation of Tumor Response to Treatment for Participants Enrolled in the Phase 1b Portion of This Study
Unevaluable
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed pre-treatment, during treatment and post-treatment at 6 to 12 week intervals, assessed up to 24 months.Population: Participants were evaluated by GCIG CA-125 response criteria.
CA-125 according to the Gynecologic Cancer Intergroup (GCIG) is measured by at least a 50% reduction in CA-125 levels from pre-treatment sample which is confirmed and maintained for at least 28 days. Pre-treatment CA-125 sample must be at least twice the upper limit of normal and obtained within 2 weeks prior to starting treatment.
Outcome measures
| Measure |
Phase 1b - Cohort 1 Participants
n=2 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu.
|
Phase 1b - Cohort 2 Participants
n=1 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 1 x 10e10 pfu.
|
Phase 1b - Cohort 3 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 2.5 x 10e10 pfu.
|
Phase 2 - Cohort C Platinum-refractory Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu and received chemotherapy with or without bevacizumab.
|
|---|---|---|---|---|
|
CA-125 Response in Participants Enrolled in the Phase 1b Portion of This Study
|
2 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of starting chemotherapy until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to 24 months.Population: Participants with at least 1 post-treatment imaging scan.
To assess the number of months of progression-free survival (PFS) by RECIST 1.1.
Outcome measures
| Measure |
Phase 1b - Cohort 1 Participants
n=2 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu.
|
Phase 1b - Cohort 2 Participants
n=1 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 1 x 10e10 pfu.
|
Phase 1b - Cohort 3 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 2.5 x 10e10 pfu.
|
Phase 2 - Cohort C Platinum-refractory Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu and received chemotherapy with or without bevacizumab.
|
|---|---|---|---|---|
|
Determine Progression-free Survival Following Treatment (Phase 1b)
|
11.6 Number of months
Interval 11.6 to
NA = Not reached
|
16.7 Number of months
Interval 16.7 to 16.7
|
—
|
—
|
SECONDARY outcome
Timeframe: By medical chart review until death or 3 years from the date of last treatment whichever comes first.Population: Participants who received at least 1 dose of Olvi-Vec treatment and chemotherapy with or without bevacizumab were included in this analysis.
To determine overall survival (OS) in the participant population.
Outcome measures
| Measure |
Phase 1b - Cohort 1 Participants
n=2 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu.
|
Phase 1b - Cohort 2 Participants
n=1 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 1 x 10e10 pfu.
|
Phase 1b - Cohort 3 Participants
n=13 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 2.5 x 10e10 pfu.
|
Phase 2 - Cohort C Platinum-refractory Participants
n=11 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu and received chemotherapy with or without bevacizumab.
|
|---|---|---|---|---|
|
Overall Survival
|
33.6 Number of months
Interval 33.6 to
NA = Not reached
|
61.7 Number of months
Interval 61.7 to
NA = Not reached
|
18.5 Number of months
Interval 11.3 to 23.8
|
12.7 Number of months
Interval 3.2 to 15.7
|
SECONDARY outcome
Timeframe: Approximately 24 monthsPopulation: Participants who had at least 1 post-treatment imaging scan.
Defined as the percentage of patients who have achieved CR + PR + SD by RECIST 1.1.
Outcome measures
| Measure |
Phase 1b - Cohort 1 Participants
n=2 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu.
|
Phase 1b - Cohort 2 Participants
n=1 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 1 x 10e10 pfu.
|
Phase 1b - Cohort 3 Participants
n=11 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 2.5 x 10e10 pfu.
|
Phase 2 - Cohort C Platinum-refractory Participants
n=8 Participants
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu and received chemotherapy with or without bevacizumab.
|
|---|---|---|---|---|
|
Clinical Benefit Rate
|
100 Percent of participants
|
100 Percent of participants
|
91 Percent of participants
|
100 Percent of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed post-treatment at 6 to 12 week intervals or until disease progression or death from any cause, whichever comes first, assessed up to 24 months.Population: This exploratory endpoint is considered not evaluable (NE) based on Immune-related response assessment criteria not being met.
This exploratory outcome measure evaluates participants' best overall response to treatment with oncolytic immunotherapy assessed by Immune-related Response Criteria (immune-related complete response, immune-related partial response, immune-related stable disease, or immune-related progressive disease).
Outcome measures
Outcome data not reported
Adverse Events
Phase 1b - Cohort 1
Serious events: 2 serious events
Other events: 5 other events
Deaths: 5 deaths
Phase 1b - Cohort 2
Serious events: 1 serious events
Other events: 5 other events
Deaths: 5 deaths
Phase 1b - Cohort 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Phase 2 - Cohort A
Serious events: 5 serious events
Other events: 22 other events
Deaths: 22 deaths
Phase 2 - Cohort C
Serious events: 2 serious events
Other events: 11 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Phase 1b - Cohort 1
n=6 participants at risk
Participants treated in Cohort 1 received 2 IP infusions at 3 x 10e9 pfu.
|
Phase 1b - Cohort 2
n=5 participants at risk
Participants treated in Cohort 2 received 2 IP infusions at 1 x 10e10 pfu.
|
Phase 1b - Cohort 3
n=1 participants at risk
Participants treated in Cohort 3 received 2 IP infusions at 2.5 x 10e10 pfu.
|
Phase 2 - Cohort A
n=22 participants at risk
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu and received chemotherapy with or without bevacizumab.
|
Phase 2 - Cohort C
n=11 participants at risk
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu and received chemotherapy with or without bevacizumab.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
4.5%
1/22 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
9.1%
1/11 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
13.6%
3/22 • Number of events 3 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
General disorders
Asthenia
|
16.7%
1/6 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
General disorders
Fatigue
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
9.1%
1/11 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
20.0%
1/5 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
4.5%
1/22 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
Other adverse events
| Measure |
Phase 1b - Cohort 1
n=6 participants at risk
Participants treated in Cohort 1 received 2 IP infusions at 3 x 10e9 pfu.
|
Phase 1b - Cohort 2
n=5 participants at risk
Participants treated in Cohort 2 received 2 IP infusions at 1 x 10e10 pfu.
|
Phase 1b - Cohort 3
n=1 participants at risk
Participants treated in Cohort 3 received 2 IP infusions at 2.5 x 10e10 pfu.
|
Phase 2 - Cohort A
n=22 participants at risk
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu and received chemotherapy with or without bevacizumab.
|
Phase 2 - Cohort C
n=11 participants at risk
Participants received 2 consecutive days of intraperitoneal infusions of Olvi-Vec at 3 x 10e9 pfu and received chemotherapy with or without bevacizumab.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
13.6%
3/22 • Number of events 3 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
9.1%
1/11 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
4.5%
1/22 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
4.5%
1/22 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
16.7%
1/6 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
4.5%
1/22 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Number of events 2 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
22.7%
5/22 • Number of events 5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
18.2%
2/11 • Number of events 2 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • Number of events 4 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
60.0%
3/5 • Number of events 3 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
68.2%
15/22 • Number of events 15 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
18.2%
2/11 • Number of events 2 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
20.0%
1/5 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
40.0%
2/5 • Number of events 2 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
100.0%
1/1 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
4.5%
1/22 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
9.1%
1/11 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
9.1%
2/22 • Number of events 2 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
18.2%
2/11 • Number of events 2 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
80.0%
4/5 • Number of events 4 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
100.0%
1/1 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
68.2%
15/22 • Number of events 15 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
27.3%
3/11 • Number of events 3 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • Number of events 2 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
20.0%
1/5 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
68.2%
15/22 • Number of events 15 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
45.5%
5/11 • Number of events 5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
13.6%
3/22 • Number of events 3 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
9.1%
2/22 • Number of events 2 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
General disorders
Asthenia
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
9.1%
2/22 • Number of events 2 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
18.2%
2/11 • Number of events 2 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
General disorders
Chills
|
33.3%
2/6 • Number of events 2 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
100.0%
5/5 • Number of events 5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
22.7%
5/22 • Number of events 5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
45.5%
5/11 • Number of events 5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
General disorders
Fatigue
|
33.3%
2/6 • Number of events 2 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
20.0%
1/5 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
36.4%
8/22 • Number of events 8 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
36.4%
4/11 • Number of events 4 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
General disorders
Influenza like illness
|
16.7%
1/6 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
General disorders
Malaise
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
18.2%
2/11 • Number of events 2 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
27.3%
6/22 • Number of events 6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
27.3%
3/11 • Number of events 3 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
General disorders
Pyrexia
|
33.3%
2/6 • Number of events 2 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
60.0%
3/5 • Number of events 3 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
68.2%
15/22 • Number of events 15 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
72.7%
8/11 • Number of events 8 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
13.6%
3/22 • Number of events 3 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
18.2%
2/11 • Number of events 2 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
9.1%
2/22 • Number of events 2 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
9.1%
1/11 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
16.7%
1/6 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
1/6 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
16.7%
1/6 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
18.2%
2/11 • Number of events 2 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
9.1%
1/11 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
20.0%
1/5 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
4.5%
1/22 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
20.0%
1/5 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
16.7%
1/6 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
13.6%
3/22 • Number of events 3 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
27.3%
3/11 • Number of events 3 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
9.1%
1/11 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
9.1%
1/11 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
20.0%
1/5 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
9.1%
1/11 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
9.1%
1/11 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
9.1%
1/11 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
4.5%
1/22 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
18.2%
2/11 • Number of events 2 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
4.5%
1/22 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
9.1%
1/11 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Nervous system disorders
Paresthesia
|
16.7%
1/6 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Nervous system disorders
Somnolence
|
33.3%
2/6 • Number of events 2 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Psychiatric disorders
Confusional state
|
16.7%
1/6 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
4.5%
1/22 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
9.1%
1/11 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
9.1%
1/11 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
16.7%
1/6 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
9.1%
1/11 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
9.1%
1/11 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
9.1%
2/22 • Number of events 2 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
9.1%
2/22 • Number of events 2 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
4.5%
1/22 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
9.1%
1/11 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
4.5%
1/22 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Vascular disorders
Flushed
|
0.00%
0/6 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
9.1%
1/11 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
|
Vascular disorders
Lymphoedema
|
16.7%
1/6 • Number of events 1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/5 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/1 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/22 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
0.00%
0/11 • During GL-ONC1 treatment and until the 30-day Post-treatment for an average of 2 years.
|
Additional Information
Terry A. Chamberlin, CCRA - Executive Director, Clinical Trial Operations
Genelux Corportion
Phone: 619-865-6759
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60