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

Recurrent Ovarian Carcinoma Clinical Trial

Official title: Randomized Phase I/II Study of AVB-S6-500 in Combination With Durvalumab (MEDI4736) in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian Cancer

Status Active, not recruiting

Clinical Trial Summary

This trial studies the side effects and best dose of AVB-S6-500 when given together with durvalumab in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that is resistant to platinum therapy or has come back. Immunotherapy with AVB-S6-500 and durvalumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. To determine toxicity profile of the combination of batiraxcept (AVB-S6-500) and durvalumab therapy.

SECONDARY OBJECTIVES:

I. To estimate objective response rate to combination AVB-S6-500 and durvalumab therapy.

II. To estimate the median immune-related progression free survival (irPFS) as well as overall survival (OS) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 after treatment with combination durvalumab and AVB-S6-500.

III. To investigate molecular and immunological changes associated with the combination of AVB-S6-500 and durvalumab; specifically to describe changes in T cell populations (including but not limited to CD3, CD8, CD4, FOXP3) and cell proliferation, as well as report changes in the proportion of macrophage phenotypes M1 and M2 (with phenotypic markers potentially including arginase1, CD11b, PDL-1, and CD206).

EXPLORATORY OBJECTIVES:

I. To evaluate blood and tissue based biomarkers for immune related adverse events and disease progression.

II. To investigate impact and possible sensitization of pretreatment with AVB-S6-500 monotherapy on subsequent combination of durvalumab and AVB-S6-500.

III. To evaluate for molecular and immunologic differences between pre-treatment with single agent AVB-S6-500 as compared to durvalumab.

OUTLINE: This is a phase I, dose-escalation of batiraxcept, followed by a phase II study. In Phase I, patients receive both batiraxcept (intravenously [IV] over 60 minutes on days 1 and 15) and durvalumab (IV over 60 minutes on day 1) every cycle.

In Phase II, patients are randomized to 1 of 2 arms.

ARM I: Patients receive batiraxcept IV over 60 minutes on days 1, 15, and 29 of cycle 0, and on days 1 and 15 of subsequent cycles. Beginning cycle 1, patients also receive durvalumab IV over 60 minutes on day 1. Cycle 0 continues for 6 weeks and subsequent cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive durvalumab IV over 60 minutes on days 1 and 22 of cycle 0 and on day 1 of subsequent cycles. Beginning cycle 1, patients also receive batiraxcept IV over 60 minutes on days 1 and 15. Cycle 0 continues for 6 weeks and subsequent cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 weeks for at least 90 days. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Ovarian Epithelial
• Fallopian Tube Neoplasms
• Ovarian Neoplasms
• Platinum-Resistant Fallopian Tube Carcinoma
• Platinum-Resistant Ovarian Carcinoma
• Platinum-Resistant Primary Peritoneal Carcinoma
• Recurrence
• Recurrent Fallopian Tube Carcinoma
• Recurrent Ovarian Carcinoma
• Recurrent Primary Peritoneal Carcinoma
• Refractory Fallopian Tube Carcinoma
• Refractory Ovarian Carcinoma
• Refractory Primary Peritoneal Carcinoma

• NCT number: NCT04019288
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: October 11, 2019
• Completion date: August 30, 2024