A Phase II Safety and Efficacy Study of Ipilimumab Monotherapy Following Completion of Chemotherapy in Recurrent Platinum Sensitive Ovarian Cancer Subjects With Residual Measurable Disease
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer
Female
Ovarian Cancer
Trial Information
A Phase II Safety and Efficacy Study of Ipilimumab Monotherapy Following Completion of Chemotherapy in Recurrent Platinum Sensitive Ovarian Cancer Subjects With Residual Measurable Disease
Condition: Ovarian Cancer, Second Line, Third Line, or Fourth Line
Inclusion Criteria:
- Recurrent Platinum Sensitive
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Exclusion Criteria:
- Platinum Refractory ovarian cancer
- More than 4 lines of prior therapy
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The incidence of drug-related adverse events of grade 3 or higher during the induction period of Ipilimumab
Outcome Time Frame:
Up to Week 24
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA184-201
NCT ID:
NCT01611558
Start Date:
August 2012
Completion Date:
March 2016
Related Keywords:
- Ovarian Cancer
- Ovarian Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| Montefiore Medical Center | Bronx, New York 10467-2490 |
| Duke University Medical Center | Durham, North Carolina 27710 |
| Dana-Farber Cancer Inst | Boston, Massachusetts 02115 |
| Tulsa Cancer Institute, Pllc | Tulsa, Oklahoma 74136 |
| Dr. Sudarshan K. Sharma, Ltd. | Hinsdale, Illinois 60521 |
| Women's Cancer Care | Covington, Louisiana 70433 |
| The Charlotte-Mecklenburg Hospital Authority | Charlotte, North Carolina 28204 |
| University Of Oklahoma Peggy & Charles Stephenson Cancer Center | Oklahoma City, Oklahoma 73104 |
