A Phase II Study of Ivonescimab Combined With Intraperitoneal Paclitaxel in Patients With High-Grade Metastatic Appendiceal Adenocarcinoma (AA)
M.D. Anderson Cancer Center
Summary
To evaluate the safety and effectiveness of Ivonescimab combined with intraperitoneal paclitaxel (IP PTX) in patients with unresectable metastatic high-grade Appendiceal Adenocarcinoma (AA).
Description
PRIMARY OBJECTIVES To evaluate the safety and efficacy as measured by the disease control rate (DCR) of Ivonescimab combined with IP PTX in patients with unresectable metastatic high-grade AA SECONDARY OBJECTIVES: I. To evaluate progression free survival (PFS) following treatment with ivonescimab and IP PTX in patients with unresectable metastatic high-grade AA. II. To evaluate overall survival following treatment with ivonescimab and IP PTX in patients with unresectable metastatic high-grade AA. III. To evaluate the prognostic value of biochemical response including serum tumor markers an…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria * Age 18 years and above. There will be no upper age restriction * ECOG performance status 0-2 * Participants must have histologically confirmed diagnosis of unresectable metastatic AA. The determination of appendiceal origin may rely on pathologic features combined with clinical or radiographic evidence in the event that the appendix remains in situ. * Participants will have undergone no more than two prior lines of systemic therapy. The last dose of systemic therapy will have been no less than 2 weeks prior to initiation of therapy. * Participants must have adequate nutri…
Interventions
- DrugIvonescimab
Given by IV
- DrugIP PTX
Given by IP port
Location
- UT MD Anderson Cancer CenterHouston, Texas