Phase II Study of Ipilimumab Monotherapy in Recurrent Platinum Sensitive Ovarian Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01611558
First received: May 25, 2012
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

To assess the incidence of drug-related adverse events of Grade 3 or higher during the induction period of Ipilimumab.


Condition Intervention Phase
Ovarian Cancer
Biological: Ipilimumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Incidence of drug-related adverse events of grade 3 or higher during the induction period of Ipilimumab [ Time Frame: Up to Week 24 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Best overall response rate (BORR) [ Time Frame: Weeks, 6, 12, 18, and 24 during induction phase, and every 12 weeks during maintenance phase until Progressive Disease (PD) by RECIST v1.1 ] [ Designated as safety issue: No ]
    BORR is defined as the proportion of all response assessable treated subjects whose best response at any time during the study to date following initiation of therapy is confirmed complete response (CR) or confirmed partial response (PR). This will be assessed separately by response evaluation criteria in solid tumors (RECIST) v1.1 criteria and by CA125 Rustin criteria.


Estimated Enrollment: 40
Study Start Date: November 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm: Ipilimumab
Intravenous (IV) solution, IV, 10 mg/kg, Once every 3 weeks for 4 doses; then once every 12 weeks starting at Week 24, Until disease progression or unacceptable toxicity (for a maximum treatment period of 3 years from the first dose)
Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS-734016

Detailed Description:

Condition: Ovarian Cancer, Second Line, Third Line, or Fourth Line

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01611558

Locations
United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
United States, Florida
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30308
United States, Illinois
Dr. Sudarshan K. Sharma, Ltd.
Hinsdale, Illinois, United States, 60521
United States, Indiana
Indiana University Health Melvin And Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Women'S Cancer Care
Covington, Louisiana, United States, 70433
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Metrohealth Medical Center
Cleveland, Ohio, United States, 44109
United States, Oklahoma
Peggy And Charles Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Tulsa Cancer Institute
Tulsa, Oklahoma, United States, 74146
United States, Pennsylvania
Magee-Womens Hospital Of Upmc
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01611558     History of Changes
Other Study ID Numbers: CA184-201
Study First Received: May 25, 2012
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on September 18, 2014