STOMP OUT: A Phase 2 Study To Evaluate The Effects Of Ivonescimab In Patients With Unresectable/Metastatic Adrenocortical Carcinoma (ACC) Or Unresectable Pheochromocytoma/Paraganglioma (PPGL)
M.D. Anderson Cancer Center
Summary
To learn if ivonescimab can help to control previously treated, locally advanced or metastatic ACC or PPGL.
Description
Primary Objectives To estimate objective response rate (ORR) in both arms. Secondary Objectives 1. To estimate progression free survival in both arms 2. To estimate overall survival in both arms 3. To estimate disease control rate 4. To evaluate safety of the study drug in both arms
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Eligibility Criteria 1. 18 years of age or older. Because no dosing or adverse event data are currently available on the use of Ivonescimab in participants \<18 years of age, children are excluded from this study. 2. Histological confirmation of ACC or PPGL. Histological confirmation of ACC based on either: i). Weiss Score of ≥ 3 in participants who had earlier surgical resection (Lin-Weiss-Bisceglia system will be used for oncocytic ACC) OR ii). biopsy results compatible with ACC in the context of clinical setting highly suggestive of ACC (adrenal mass \> 4 cm invading surrounding organs or…
Interventions
- DrugIvonescimab
Given by IV
Location
- MD Anderson Cancer CenterHouston, Texas