Purpose of this Study
We are doing this study to find out if an experimental drug called ADP-A2M4CD8 (the study drug) is a safe and effective option for your cancer when it’s given alone or in combination with nivolumab. The study drug is custom-made for each participant from their own white blood cells or T-cells. We collect these cells using a procedure called leukapheresis.
Who Can Participate?
Eligibility
Adults ages 18-75 who:
- Test positive for certain HLA-A type and MAGE-A4 antigen proteins
- Are diagnosed with ovarian cancer
- Have received at least one round of previous treatment
What is Involved?
Description
If you choose to join this study, you will:
- Provide a blood sample or cheek swab and tumor tissue to test for particular proteins in your body
- Undergo leukapheresis to collect your white blood cells or T-cells to make the study drug
- Receive lympho-depleting chemotherapy
- Take the study drug alone or in combination with nivolumab
- Provide tumor tissue
- Have physical exams, blood draws, and give urine samples
- Have imaging scans (CT and/or MRI)
- Have heart tests (ECG)
Study Details
Full Title
A Phase 2, Open-Label, Randomized, Non-Comparative Clinical Trial of ADP-A2M4CD8 Monotherapy and in Combination With Nivolumab in Subjects With Recurrent Ovarian Cancers (SURPASS-3 STUDY/ GOG-3084)
Principal Investigator
Jeffrey
Clarke
Protocol Number
PRO00114393
NCT ID
NCT05601752
Phase
II
Enrollment Status
Pending Open to Enrollment