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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 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: June 25, 2014
Last verified: May 2014

May 25, 2012
June 25, 2014
August 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 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
Other Names:
  • Yervoy
  • BMS-734016
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)
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: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.
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
May 2014

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