A Phase II Safety and Efficacy Study of Ipilimumab Monotherapy in Recurrent Platinum Sensitive Ovarian Cancer Subjects

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%
Grade 3-4 AE: 50%

Conclusion

Encouraging anti-tumor activity, but serious side effects observed

Reference

ClinicalTrials.gov, NCT01611558
https://clinicaltrials.gov/ct2/show/NCT01611558?term=NCT01611558&rank=1