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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
Open (Enrolling)
Female
Ovarian Cancer

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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