Trial ID # | NCT01611558 |
Phase | II |
Drug Class | Immunotherapy: Checkpoint Inhibitors/CTLA-4 |
Drug Name | Ipilimumab |
Alternate Drug Names | Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, MDX-010, Yervoy |
Drugs in Trial | Ipilimumab |
Eligible Participant | Platinum sensitive recurrence and PR, SD or PD in most recent chemotherapy, ≤ 4 prior therapies |
Patients Enrolled | 49 |
Therapy Setting | Recurrence |
Study Design | Open-Label, Non-randomized |
Endpoints | ORR, evaluated per RECIST |
Efficacy | ORR: 10.3% (n=39) |
Clinically Significant Adverse Events | Serious AE: 45% |
Conclusion | Encouraging anti-tumor activity, but serious side effects observed |
Reference | ClinicalTrials.gov, NCT01611558 |