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

This study is currently recruiting participants.
Verified January 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01611558
First received: May 25, 2012
Last updated: January 23, 2014
Last verified: January 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 according to immune-related response criteria (irRC), as well as 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 Biological: 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01611558

Contacts
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations
United States, Connecticut
Yale University School Of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Contact: Alessandro Santin, Site 012    203-785-4796      
United States, Florida
Florida Hospital Cancer Institute Recruiting
Orlando, Florida, United States, 32804
Contact: Robert Holloway, Site 009    407-303-2498      
H. Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Robert Wenham, Site 0020    813-972-8329      
United States, Georgia
Winship Cancer Institute, Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: William Read, Site 0019    404-778-1900      
Georgia Regents University Recruiting
Augusta, Georgia, United States, 30912-3335
Contact: Sharad A Ghamande, Site 002         
United States, Illinois
Dr. Sudarshan K. Sharma, Ltd. Recruiting
Hinsdale, Illinois, United States, 60521
Contact: Sudarshan K Sharma, Site 0017         
United States, Indiana
Indiana University Melvin And Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Daniela Matei, Site 014    317-274-2153      
United States, Louisiana
Women'S Cancer Care Recruiting
Covington, Louisiana, United States, 70433
Contact: Patricia S Braly, Site 003         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Ursula Matulonis, Site 0022         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Ursula Matulonis, Site 011    617-632-6191      
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Mark H Einstein, Site 005    718-920-6648      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Rachel Grisham, Site 010    212-639-2153      
United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
Contact: James Hall, Site 008    980-442-2000      
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Angeles Alvarez Secord, Site 001    919-575-7213      
United States, Ohio
Metrohealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109-1998
Contact: Peter Rose, Site 0021    216-778-5154      
United States, Oklahoma
Peggy And Charles Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Katherine Moxley, Site 0018         
Tulsa Cancer Institute Recruiting
Tulsa, Oklahoma, United States, 74146
Contact: Daron Street, Site 013    918-292-8574      
United States, Pennsylvania
Local Institution Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Site 0024         
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: January 23, 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 April 16, 2014