Trial · NCT04019288

AVB-S6-500 and Durvalumab in Treating Patients With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

NCT04019288, Phase 1, Phase 2, Terminated, M.D. Anderson Cancer Center; results first posted 2025-06-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. AVB-S6-500 and Durvalumab in Treating Patients With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Trials, record NCT04019288. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04019288

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: AVB-S6-500 and Durvalumab in Treating Patients With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT number: NCT04019288
Status: Terminated
Phases: Phase 1, Phase 2
Enrollment: 12 participants, actual
Lead sponsor: M.D. Anderson Cancer Center
Conditions: Platinum-Resistant Fallopian Tube Carcinoma, Platinum-Resistant Ovarian Carcinoma, Platinum-Resistant Primary Peritoneal Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Refractory Fallopian Tube Carcinoma, Refractory Ovarian Carcinoma, Refractory Primary Peritoneal Carcinoma
Interventions: Batiraxcept, Durvalumab
First posted: 2019-07-15
Last updated: 2025-06-11
Results first posted: 2025-06-11

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Adverse Events	35 months
Secondary	To Estimate Objective Response Rate to Combination AVB-S6-500 and Durvalumab Therapy	35 months
Secondary	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	35 months
Secondary	To Investigate Molecular and Immunological Changes Associated With the Combination of AVBS6-500 and Durvalumab.	35 months	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.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Adverse Events	35 months	Treatment never progressed passed phase 1.	participants	NUMBER
SECONDARY	To Estimate Objective Response Rate to Combination AVB-S6-500 and Durvalumab Therapy	35 months	Treatment never progressed passed phase 1.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	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	35 months	Treatment never progressed passed phase 1.	Months	MEDIAN
SECONDARY	To Investigate Molecular and Immunological Changes Associated With the Combination of AVBS6-500 and Durvalumab.	35 months	Treatment never progressed passed phase 1.	ng/mL	MEDIAN

Source ClinicalTrials.gov

Results by group9

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Adverse Events	Phase 1	Grade 1 AEs	11		participants
Number of Participants With Adverse Events	Phase 1	Grade 2 AEs	9		participants
Number of Participants With Adverse Events	Phase 1	Grade 3 AEs	3		participants
Number of Participants With Adverse Events	Phase 1	Grade 2 SAEs	2		participants
Number of Participants With Adverse Events	Phase 1	Grade 3 SAEs	1		participants
To Estimate Objective Response Rate to Combination AVB-S6-500 and Durvalumab Therapy	Phase 1		11		Participants
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	Phase 1	PFS	1.81	95% Confidence Interval 1.71 to 2.40	Months
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	Phase 1	OS	4.53	95% Confidence Interval 2.10 to 24.74	Months
To Investigate Molecular and Immunological Changes Associated With the Combination of AVBS6-500 and Durvalumab.	Phase 1		30.5	Full Range 5.6 to 45.1	ng/mL

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Phase 1	11
Overall Study	STARTED	Phase 2A	0
Overall Study	STARTED	Phase 2D	0
Overall Study	COMPLETED	Phase 1	10
Overall Study	COMPLETED	Phase 2A	0
Overall Study	COMPLETED	Phase 2D	0
Overall Study	NOT COMPLETED	Phase 1	1
Overall Study	NOT COMPLETED	Phase 2A	0
Overall Study	NOT COMPLETED	Phase 2D	0

Source ClinicalTrials.gov

Adverse events96

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anemia	Blood and lymphatic system disorders	Phase 1	2	11	5
other	Anemia	Blood and lymphatic system disorders	Phase 2A	0	0
other	Anemia	Blood and lymphatic system disorders	Phase 2D	0	0
other	Alanine aminotransferase increased	Investigations	Phase 1	1	11	1
other	Alanine aminotransferase increased	Investigations	Phase 2A		0
other	Alanine aminotransferase increased	Investigations	Phase 2D		0
other	Alkaline phosphatase increased	Investigations	Phase 1	1	11	1
other	Alkaline phosphatase increased	Investigations	Phase 2A		0
other	Alkaline phosphatase increased	Investigations	Phase 2D		0
other	Anorexia	Metabolism and nutrition disorders	Phase 1	2	11	2

1 to 10 of 96Source ClinicalTrials.gov

See all 96 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase 1	1	11
Total, all-cause mortality	Phase 2A	0	0
Total, all-cause mortality	Phase 2D	0	0
Total, other adverse events	Phase 1	11	11
Total, other adverse events	Phase 2A	0	0
Total, other adverse events	Phase 2D	0	0
Total, serious adverse events	Phase 1	3	11
Total, serious adverse events	Phase 2A	0	0
Total, serious adverse events	Phase 2D	0	0

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA016672	The University of Texas MD Anderson Cancer Center Support Grant (CCSG)	KOONG, ALBERT	UNIVERSITY OF TX MD ANDERSON CAN CTR	NATIONAL CANCER INSTITUTE	1985 to 2026

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04019288

GET https://conductscience.org/api/trials/v1/NCT04019288/events?page=2

API reference For AI assistants