Safety and Efficacy of Anti-CD47, ALX148 in Combination with Liposomal Doxorubicin and Pembrolizumab in Patients with Recurrent Platinum-resistant Ovarian Cancer: Phase II Study
Immunotherapy with immune checkpoint inhibitors, including pembrolizumab, have emerged as a promising option in several solid cancers with durable effect and low toxicity profile. However, the benefit is limited to smaller subset of solid tumors. This trial involves the enhancement of current immune checkpoint-based immunotherapy with ALX148, an agent that inhibits CD47 (a trans-membrane protein that is highly expressed on the surface of many solid tumors as compared to normal cells).
• Participants must have recurrent epithelial ovarian cancer.
• Platinum-resistant disease: Patients who recur within \< 6 months of prior platinum-based therapy excluding those with primary platinum refractory disease (see exclusion criteria).
• Following histology types are acceptable: high grade serous or high grade endometrioid, clear cells, high grade translational cell, poorly differentiated or undifferentiated carcinomas, mixed histology (including one of above histology).
• 0-3 prior lines in platinum-resistant setting.
• Known BRCA status or willing to be tested.
• Up to 5 prior lines of therapy are allowed.
• Participants must have measurable disease based on RECIST 1.1 with at least one target lesion.
• Participants must have an ECOG performance status of 0-1.
• Participants must be female, Age \>18 years. Because no dosing or AE data are currently available on the use of pembrolizumab in combination with ALX148 in participants ≤18 years of age, children are excluded from this study.
⁃ Participants must have normal organ and marrow function as defined below within 14 days of enrollment unless otherwise indicated.
⁃ Participants must have the ability to understand and the willingness to sign a written informed consent document.
⁃ Negative serum or urine pregnancy test at screening for women of childbearing potential.
⁃ Willing to use highly effective contraception throughout the study and for at least 4 months after last treatment administration if childbearing potential exists.
⁃ Availability of an archival FFPE tumor tissue block from primary diagnosis specimen, metastatic, or recurrent site. If an FFPE tissue block cannot be provided then 15 unstained slides (10 microns, 10 slides minimum) will be acceptable. Please refer to the laboratory manual for complete details.