Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

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
Type
Interventional
Phase
Phase 1Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

PRIMARY OBJECTIVES: I. To determine toxicity profile of the combination of anti-AXL fusion protein AVB-S6-500 (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...

PRIMARY OBJECTIVES: I. To determine toxicity profile of the combination of anti-AXL fusion protein AVB-S6-500 (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 anti-AXL fusion protein AVB-S6-500, followed by a phase II study. In Phase I, patients receive both anti-AXL fusion protein AVB-S6-500 (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 anti-AXL fusion protein AVB-S6-500 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 anti-AXL fusion protein AVB-S6-500 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.

Tracking Information

NCT #
NCT04019288
Collaborators
  • Aravive Biologics Inc
  • AstraZeneca
  • National Cancer Institute (NCI)
Investigators
Principal Investigator: Amir A Jazaeri M.D. Anderson Cancer Center