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

May 25, 2012
January 23, 2014
November 2012
December 2014   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT01611558 on ClinicalTrials.gov Archive Site
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
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 Immune-Related Progressive Disease (irPD) ] [ Designated as safety issue: No ]
Best overall response rate (BORR) assessed according to immune-related response criteria (irRC), as well as separately by Modified World Health Organization criteria (mWHO) criteria, and by CA125 Rustin criteria
Not Provided
Not Provided
 
Phase II Study of Ipilimumab Monotherapy in Recurrent Platinum Sensitive Ovarian Cancer Patients
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

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

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

Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Cancer
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
Experimental: Arm: Ipilimumab
Intervention: Biological: Ipilimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2016
December 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
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.
United States
 
NCT01611558
CA184-201
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP