Trial Outcomes & Findings for AVB-S6-500 and Durvalumab in Treating Patients With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (NCT NCT04019288)
NCT ID: NCT04019288
Last Updated: 2025-06-11
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
35 months
Results posted on
2025-06-11
Participant Flow
The study recruitment was from December 2019 until November 2022 and all recruitments were done in a medical clinic setting.
Participant milestones
| Measure |
Phase 1
Durvalumab 1500 mg IV every 4 weeks + AVB-S6-500 10 mg/kg IV every 2 weeks
|
Phase 2A
Monotherapy with AVB-S6-500 IV 10 mg/kg every 2 weeks for 6 weeks then combination of Durvalumab 1500 mg IV every 4 weeks + AVB-S6-500 10 mg/kg IV every 2 weeks
|
Phase 2D
Monotherapy with Durvalumab 1500 mg IV every 4 weeks for 6 weeks then combination of Durvalumab 1500 mg IV every 4 weeks + AVB-S6-500 10 mg/kg IV every 2 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
0
|
0
|
|
Overall Study
COMPLETED
|
10
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase 1
Durvalumab 1500 mg IV every 4 weeks + AVB-S6-500 10 mg/kg IV every 2 weeks
|
Phase 2A
Monotherapy with AVB-S6-500 IV 10 mg/kg every 2 weeks for 6 weeks then combination of Durvalumab 1500 mg IV every 4 weeks + AVB-S6-500 10 mg/kg IV every 2 weeks
|
Phase 2D
Monotherapy with Durvalumab 1500 mg IV every 4 weeks for 6 weeks then combination of Durvalumab 1500 mg IV every 4 weeks + AVB-S6-500 10 mg/kg IV every 2 weeks
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
Baseline Characteristics
AVB-S6-500 and Durvalumab in Treating Patients With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Phase 1
n=11 Participants
Durvalumab 1500 mg IV every 4 weeks + AVB-S6-500 10 mg/kg IV every 2 weeks
|
Phase 2A
Monotherapy with AVB-S6-500 IV 10 mg/kg every 2 weeks for 6 weeks then combination of Durvalumab 1500 mg IV every 4 weeks + AVB-S6-500 10 mg/kg IV every 2 weeks
|
Phase 2D
Monotherapy with Durvalumab 1500 mg IV every 4 weeks for 6 weeks then combination of Durvalumab 1500 mg IV every 4 weeks + AVB-S6-500 10 mg/kg IV every 2 weeks
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
—
|
—
|
10 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
—
|
—
|
1 Participants
n=4 Participants
|
|
Age, Continuous
|
56.9 years
n=5 Participants
|
—
|
—
|
56.9 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
—
|
—
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
—
|
—
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
—
|
—
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
—
|
—
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
—
|
—
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
—
|
—
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
—
|
—
|
11 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 35 monthsPopulation: Treatment never progressed passed phase 1.
Outcome measures
| Measure |
Phase 1
n=11 Participants
Durvalumab 1500 mg IV every 4 weeks + AVB-S6-500 10 mg/kg IV every 2 weeks
|
Phase 2A
Monotherapy with AVB-S6-500 IV 10 mg/kg every 2 weeks for 6 weeks then combination of Durvalumab 1500 mg IV every 4 weeks + AVB-S6-500 10 mg/kg IV every 2 weeks
|
Phase 2D
Monotherapy with Durvalumab 1500 mg IV every 4 weeks for 6 weeks then combination of Durvalumab 1500 mg IV every 4 weeks + AVB-S6-500 10 mg/kg IV every 2 weeks
|
|---|---|---|---|
|
Number of Participants With Adverse Events
Grade 1 AEs
|
11 participants
|
—
|
—
|
|
Number of Participants With Adverse Events
Grade 2 AEs
|
9 participants
|
—
|
—
|
|
Number of Participants With Adverse Events
Grade 3 AEs
|
3 participants
|
—
|
—
|
|
Number of Participants With Adverse Events
Grade 2 SAEs
|
2 participants
|
—
|
—
|
|
Number of Participants With Adverse Events
Grade 3 SAEs
|
1 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 35 monthsPopulation: Treatment never progressed passed phase 1.
Outcome measures
| Measure |
Phase 1
n=11 Participants
Durvalumab 1500 mg IV every 4 weeks + AVB-S6-500 10 mg/kg IV every 2 weeks
|
Phase 2A
Monotherapy with AVB-S6-500 IV 10 mg/kg every 2 weeks for 6 weeks then combination of Durvalumab 1500 mg IV every 4 weeks + AVB-S6-500 10 mg/kg IV every 2 weeks
|
Phase 2D
Monotherapy with Durvalumab 1500 mg IV every 4 weeks for 6 weeks then combination of Durvalumab 1500 mg IV every 4 weeks + AVB-S6-500 10 mg/kg IV every 2 weeks
|
|---|---|---|---|
|
To Estimate Objective Response Rate to Combination AVB-S6-500 and Durvalumab Therapy
|
11 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 35 monthsPopulation: Treatment never progressed passed phase 1.
Outcome measures
| Measure |
Phase 1
n=11 Participants
Durvalumab 1500 mg IV every 4 weeks + AVB-S6-500 10 mg/kg IV every 2 weeks
|
Phase 2A
Monotherapy with AVB-S6-500 IV 10 mg/kg every 2 weeks for 6 weeks then combination of Durvalumab 1500 mg IV every 4 weeks + AVB-S6-500 10 mg/kg IV every 2 weeks
|
Phase 2D
Monotherapy with Durvalumab 1500 mg IV every 4 weeks for 6 weeks then combination of Durvalumab 1500 mg IV every 4 weeks + AVB-S6-500 10 mg/kg IV every 2 weeks
|
|---|---|---|---|
|
To Estimate the Median Immune-related Progression Free Survival (irPFS) as Well as Overall Survival OS by RECIST 1.1 After Treatment With Combination Durvalumab and AVB-S6-500
PFS
|
1.81 Months
Interval 1.71 to 2.4
|
—
|
—
|
|
To Estimate the Median Immune-related Progression Free Survival (irPFS) as Well as Overall Survival OS by RECIST 1.1 After Treatment With Combination Durvalumab and AVB-S6-500
OS
|
4.53 Months
Interval 2.1 to 24.74
|
—
|
—
|
SECONDARY outcome
Timeframe: 35 monthsPopulation: Treatment never progressed passed phase 1.
Serum fractions will be isolated from blood samples collected in EDTA-free tubes and will be used to measure GAS6 suppression, which will be analyzed by Altasciences.
Outcome measures
| Measure |
Phase 1
n=11 Participants
Durvalumab 1500 mg IV every 4 weeks + AVB-S6-500 10 mg/kg IV every 2 weeks
|
Phase 2A
Monotherapy with AVB-S6-500 IV 10 mg/kg every 2 weeks for 6 weeks then combination of Durvalumab 1500 mg IV every 4 weeks + AVB-S6-500 10 mg/kg IV every 2 weeks
|
Phase 2D
Monotherapy with Durvalumab 1500 mg IV every 4 weeks for 6 weeks then combination of Durvalumab 1500 mg IV every 4 weeks + AVB-S6-500 10 mg/kg IV every 2 weeks
|
|---|---|---|---|
|
To Investigate Molecular and Immunological Changes Associated With the Combination of AVBS6-500 and Durvalumab.
|
30.5 ng/mL
Interval 5.6 to 45.1
|
—
|
—
|
Adverse Events
Phase 1
Serious events: 3 serious events
Other events: 11 other events
Deaths: 1 deaths
Phase 2A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 2D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1
n=11 participants at risk
Durvalumab 1500 mg IV every 4 weeks + AVB-S6-500 10 mg/kg IV every 2 weeks
|
Phase 2A
Monotherapy with AVB-S6-500 IV 10 mg/kg every 2 weeks for 6 weeks then combination of Durvalumab 1500 mg IV every 4 weeks + AVB-S6-500 10 mg/kg IV every 2 weeks
|
Phase 2D
Monotherapy with Durvalumab 1500 mg IV every 4 weeks for 6 weeks then combination of Durvalumab 1500 mg IV every 4 weeks + AVB-S6-500 10 mg/kg IV every 2 weeks
|
|---|---|---|---|
|
General disorders
Infusion related reaction
|
18.2%
2/11 • Number of events 3 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Infections and infestations
Lung Infection
|
9.1%
1/11 • Number of events 1 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
Other adverse events
| Measure |
Phase 1
n=11 participants at risk
Durvalumab 1500 mg IV every 4 weeks + AVB-S6-500 10 mg/kg IV every 2 weeks
|
Phase 2A
Monotherapy with AVB-S6-500 IV 10 mg/kg every 2 weeks for 6 weeks then combination of Durvalumab 1500 mg IV every 4 weeks + AVB-S6-500 10 mg/kg IV every 2 weeks
|
Phase 2D
Monotherapy with Durvalumab 1500 mg IV every 4 weeks for 6 weeks then combination of Durvalumab 1500 mg IV every 4 weeks + AVB-S6-500 10 mg/kg IV every 2 weeks
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
18.2%
2/11 • Number of events 5 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Investigations
Alanine aminotransferase increased
|
9.1%
1/11 • Number of events 1 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Investigations
Alkaline phosphatase increased
|
9.1%
1/11 • Number of events 1 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Anorexia
|
18.2%
2/11 • Number of events 2 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Investigations
Aspartate aminotransferase increased
|
27.3%
3/11 • Number of events 3 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Gastrointestinal disorders
Bloating
|
9.1%
1/11 • Number of events 1 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Gastrointestinal disorders
Constipation
|
36.4%
4/11 • Number of events 5 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Number of events 1 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Investigations
Creatinine increased
|
27.3%
3/11 • Number of events 3 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Gastrointestinal disorders
Diarrhea
|
9.1%
1/11 • Number of events 1 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
1/11 • Number of events 2 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
General disorders
Fatigue
|
27.3%
3/11 • Number of events 4 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Number of events 1 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
9.1%
1/11 • Number of events 1 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Endocrine disorders
Hyperparathyroidism
|
9.1%
1/11 • Number of events 1 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Vascular disorders
Hypertension
|
9.1%
1/11 • Number of events 1 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.1%
1/11 • Number of events 1 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Metabolism and nutrition disorders
Hyponatremia
|
27.3%
3/11 • Number of events 4 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
General disorders
Infusion related reaction
|
9.1%
1/11 • Number of events 1 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Investigations
Investigations - Other, TSH decreased
|
9.1%
1/11 • Number of events 1 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Investigations
Investigations - Other, GGT increased
|
9.1%
1/11 • Number of events 1 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Investigations
Lipase increased
|
9.1%
1/11 • Number of events 1 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Infections and infestations
Lung infection
|
9.1%
1/11 • Number of events 1 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Investigations
Lymphocyte count decreased
|
9.1%
1/11 • Number of events 1 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Gastrointestinal disorders
Nausea
|
45.5%
5/11 • Number of events 6 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
18.2%
2/11 • Number of events 2 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Investigations
Serum amylase increased
|
18.2%
2/11 • Number of events 3 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Nervous system disorders
Tremor
|
9.1%
1/11 • Number of events 1 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Gastrointestinal disorders
Vomiting
|
27.3%
3/11 • Number of events 5 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
|
Investigations
White blood cell decreased
|
9.1%
1/11 • Number of events 1 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
—
0/0 • 35 months
NCI CTCAE version 4.03
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place