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

This study is currently recruiting participants.
Verified December 2012 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01611558
First received: May 25, 2012
Last updated: December 7, 2012
Last verified: December 2012
History of Changes
  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:

Drug Information available for: Ipilimumab
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • The 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:
  • BORR defined as the proportion of all 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) [ Time Frame: Weeks, 6, 12, 18, and 24 during induction phase, and every 12 weeks during maintenance phase until Progressive Disease (PD) by mWHO ] [ Designated as safety issue: No ]
    Best overall response rate (BORR) assessed according to Modified World Health Organization criteria (mWHO) criteria, immune-related response criteria (irRC), and by CA125 Rustin criteria


Estimated Enrollment: 40
Study Start Date: August 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 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

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

Locations
United States, Illinois
Dr. Sudarshan K. Sharma, Ltd. Recruiting
Hinsdale, Illinois, United States, 60521
Contact: Sudarshan K Sharma, Site 017     630-856-6757        
United States, Louisiana
Women's Cancer Care Recruiting
Covington, Louisiana, United States, 70433
Contact: Patricia S Braly, Site 003     504-885-8220        
United States, Massachusetts
Dana-Farber Cancer Inst Recruiting
Boston, Massachusetts, United States, 02115
Contact: Ursula Matulonis, Site 011     617-632-6191        
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Ursula Matulonis, 0022     617-667-9235        
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Dr. Mark Einstein, Site 005     718-920-6648        
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Rachel Grisham, Site 010     646-888-4219        
United States, North Carolina
The Charlotte-Mecklenburg Hospital Authority 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, Oklahoma
University Of Oklahoma Peggy & Charles Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Katherine Moxley, Site 0018     405-271-8777        
Tulsa Cancer Institute, Pllc Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Daron Street, Site 013     918-499-2000        
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More 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: December 7, 2012
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 May 23, 2013